Total body irradiation dose and risk of subsequent neoplasms following allogeneic hematopoietic cell transplantation.

We examined the impact of total body irradiation (TBI) dose and fractionation on risk of subsequent malignant neoplasms (SMNs) in the era of reduced-intensity and nonmyeloablative conditioning regimens for hematopoietic cell transplantation (HCT). Among 4905 1-year survivors of allogeneic HCT for hematologic malignancies (N = 4500) or nonmalignant disorders (N = 405) who received transplants between 1969 and 2014, we identified 581 SMNs (excluding squamous and basal cell of skin) in 499 individuals. With a median length of follow-up of 12.5 years, the cumulative incidence of SMNs by 30 years after HCT was 22.0%. Compared with age-, sex-, and calendar year-matched Surveillance, Epidemiology, and End Results (SEER) population rates, the standardized incidence ratio (SIR) of SMNs was increased 2.8-fold. The highest SIRs were for SMNs of bones (SIR, 28.8), oral cavity (SIR, 13.8), skin (SIR, 7.3), central nervous system (SIR, 6.0), and endocrine organs (SIR, 4.9). The highest excess absolute risks (EARs) were seen with breast cancer (EAR, 2.2) and cancers of the oral cavity (EAR, 1.5) and skin (EAR, 1.5) per 1000 person-years. The highest incidence of SMNs was in survivors exposed to unfractionated (600-1000 cGy) or high-dose fractionated (1440-1750 cGy) TBI. For patients receiving low-dose TBI, the incidence was comparable to myeloablative chemotherapy alone, although still twofold higher than in the general population. These data demonstrate a strong effect of TBI dose, dose fractionation, and risk of SMNs after HCT. The cumulative incidence of SMNs increases with follow-up time; thus, HCT survivors require lifetime monitoring for early detection and effective therapy of SMNs.

14th International HLA and Immunogenetics Workshop: report on the HLA component of type 1 diabetes.

The type 1 diabetes (T1D) component of the 13th International Histocompatibility Workshop (IHW) obtained microsatellite (msat) and human leukocyte antigen (HLA)-DR/DQ data on case/control and family samples through an international collaboration. The aim was to detect the effects of susceptibility loci on the HLA complex independent of the primary determinants in the class II region (HLA-DR/DQ). As part of the activity of the 14th International HLA and Immunogenetics Workshop (14th IHIWS), a T1D workshop was held to present analyses of the 13th IHW data and to discuss the current status of knowledge about the genetics of T1D. These data are now available online through dbMHC, a web-based resource established by the National Center for Biotechnology. Continuing work since the 13th IHW has resulted in published work showing heterogeneity of DR3 haplotypes in data sets from the 13th IHW and Human Biological Data Interchange (HBDI). In addition, we identified markers that define DRB1*1501 DQB1*0602 haplotypes conferring reduced protection from diabetes in a Swedish 13th IHW data set. Further analyses of the 13th IHW data set not only showed some significant results but also demonstrated extensive heterogeneity reminiscent of non-HLA genes. The haplotype analysis in HBDI families identified two msats with significant effects on susceptibility and statistically significant age of onset effects at class III markers that are not because of linkage disequilibrium, with class I alleles known to affect age of onset. The above studies underscore the importance of refining our understanding of susceptibility associated with genes in the HLA complex.

Chronic kidney disease in long-term survivors of hematopoietic cell transplant.

We conducted a cohort study to identify risk factors of chronic kidney disease (CKD) among long-term survivors of hematopoietic cell transplant (HCT). We studied 1635 patients transplanted at the Fred Hutchinson Cancer Research Center (FHCRC) between 1991 and 2002, who survived to day +131 after transplant and had serum creatinine measured on at least two occasions after day +131. CKD was defined as a glomerular filtration rate < 60 ml/min/m(2) on two occasions separated by at least 30 days between days 100 and 540 post transplant. Cox regression models estimated hazard ratios (HRs) describing associations between demographic data, clinical variables and the risk of developing CKD. A total of 376 patients (23%) developed CKD at a median of 191 days post transplant (range 131-516 days). An increased risk of CKD was associated with acute renal failure (ARF) (HR=1.7, 95% confidence interval (CI) 1.3-2.1), acute graft-vs-host disease (aGVHD) grade II (HR=2.0, 95% CI 1.4-2.9) and grades III/IV (HR=3.1, 95% CI 2.1-4.6) and chronic GVHD (HR=1.8, 95% CI 1.4-2.2). Total body irradiation (TBI) (HR=1.0, 95% CI 0.8-1.3) was not associated with an increased risk of CKD. CKD is relatively common among survivors of HCT. The presence of ARF and GVHD, but not receipt of TBI, appears to be associated with the occurrence of CKD.

CYP98A3 from Arabidopsis thaliana is a 3'-hydroxylase of phenolic esters, a missing link in the phenylpropanoid pathway.

The 4- and 5-hydroxylations of phenolic compounds in plants are catalyzed by cytochrome P450 enzymes. The 3-hydroxylation step leading to the formation of caffeic acid from p-coumaric acid remained elusive, however, alternatively described as a phenol oxidase, a dioxygenase, or a P450 enzyme, with no decisive evidence for the involvement of any in the reaction in planta. In this study, we show that the gene encoding CYP98A3, which was the best possible P450 candidate for a 3-hydroxylase in the Arabidopsis genome, is highly expressed in inflorescence stems and wounded tissues. Recombinant CYP98A3 expressed in yeast did not metabolize free p-coumaric acid or its glucose or CoA esters, p-coumaraldehyde, or p-coumaryl alcohol, but very actively converted the 5-O-shikimate and 5-O-d-quinate esters of trans-p-coumaric acid into the corresponding caffeic acid conjugates. The shikimate ester was converted four times faster than the quinate derivative. Antibodies directed against recombinant CYP98A3 specifically revealed differentiating vascular tissues in stem and root. Taken together, these data show that CYP98A3 catalyzes the synthesis of chlorogenic acid and very likely also the 3-hydroxylation of lignin monomers. This hydroxylation occurs on depsides, the function of which was so far not understood, revealing an additional and unexpected level of networking in lignin biosynthesis.

Relapse after allogeneic bone marrow transplantation for refractory anemia is increased by shielding lungs and liver during total body irradiation.

Patients with the refractory anemia (RA) subtype of myelodysplastic syndrome who undergo allogeneic bone marrow transplantation (BMT) have a low risk of relapse, but they have a high risk of nonrelapse mortality when prepared with conventional preparative regimens. To try to reduce nonrelapse mortality, we treated 14 RA patients with a modified approach to total body irradiation (TBI) followed by cyclophosphamide (CY) and HLA-identical sibling BMT. Median patient age was 44 years (range, 28 to 65 years). Patients received TBI with shielding of the right lobe of the liver and both lungs followed by electron beam boosts to shielded ribs. Total radiation exposure in nonshielded areas was 12 Gy (n = 10), 10 Gy (n = 3), or 6 Gy (n = 1). After TBI, patients received CY at 120 mg/kg over 2 days, followed by transplantation of unmanipulated bone marrow. All patients initially achieved engraftment with donor cells, although 2 patients had subsequent reemergence of host hematopoiesis without evidence of disease relapse. Five patients died of transplantation-related causes between 22 and 1262 days post-BMT. Four patients relapsed between 157 and 1096 days post-BMT. These 14 patients were compared with 46 historical controls with RA who received conventional CY/TBI or busulfan/CY preparative regimens. Patients in the experimental group had a similar nonrelapse mortality rate compared with the historical control group (29% versus 37%, respectively; P = .8), but a higher relapse rate (34% versus 2%, P = .0004) and a lower disease-free survival (38% versus 61%, P = .16). We conclude that this modified TBI approach is associated with an unacceptably high risk of relapse for patients with RA undergoing BMT.

A high-performance liquid chromatographic method for the determination of 8-oxo-7,8-dihydro-2'-deoxyguanosine in urine from man and rat.

The renally excreted amount of 8-oxo-7,8-dihydro-2'-deoxyguanosine (oxo(8)dG) is a potential marker of oxidative DNA damage by reactive oxygen species. We have developed a high-performance liquid chromatographic (HPLC) method to determine oxo(8)dG in urine from humans and Wistar rats. First, 300 microl of filtered urine is prefractionated by solid phase extraction (BAKERBOND SPE C(18) Polar Plus column). Then, the HPLC separation of the fraction containing oxo(8)dG is performed using four HPLC columns (two cation exchange and two C(18) columns) in series with an automated column switching technique. Quantification of oxo(8)dG is performed by electrochemical detection (Coulochem II, ESA Inc.). Limit of detection was 0.4 nM oxo(8)dG. Recovery of oxo(8)dG added respectively in 11 or 8 concentration steps (range, 4-74 or 2-23 nM) to a pooled human or rat urine was 104.1 +/- 4.3 or 104.5 +/- 7.7%. Precision of sixfold analysis of a pooled human or rat urine carried out respectively on the same day was 2.2 or 2.4% relative standard deviation. Normal excretion rates of oxo(8)dG in healthy adult humans (five females, six males; body weight, 70.7 +/- 11 kg) and male Wistar rats (body weight, 309 +/- 13 g) were 281.7 +/- 179.1 and 333.2 +/- 47.4 pmol oxo(8)dG/day/kg weight, respectively.

Renal excretion of 8-oxo-7,8-dihydro-2'-deoxyguanosine in Wistar rats with increased O(2) consumption due to cold stress.

DNA damage by reactive oxygen species is of special interest in the development of cancer and in aging. The renally excreted amount of 8-oxo-7,8-dihydro-2'-deoxyguanosine (oxo(8)dG) is a potential noninvasive marker of oxidative DNA damage. The respiratory chain of mitochondria is one source for the formation of reactive oxygen species. In the present study we investigated in Wistar rats (n = 7; mean body weight at start, 307.4 +/- 11 g) the effect of an increased O(2) consumption, i.e., energy expenditure, due to cold stress on the renally excreted amount of oxo(8)dG. First, the rats were housed for 4 days at 23.5 degrees C (basic period, BP), and then for 6 days at 10 degrees C (cold stress period, CSP), and finally for 3 days at 23.5 degrees C (recovery period, RP). The O(2) consumption (L O(2)/day/kg weight) was significantly (P < 0.0001) on average 50% higher in CSP (69.0 +/- 3.9) than in BP (45.8 +/- 4.8), and similar in BP and RP (44.3 +/- 5.4). The average renal excretion of oxo(8)dG (pmol/day/kg weight) was significantly (P < 0.025) on average 13% higher in CSP (375.5 +/- 27.7) than in BP (333.2 +/- 47. 4) and similar in BP and RP (331.8 +/- 34.3). Maximum increase in oxo(8)dG excretion of on average 17% was on the third to fifth day of the CSP. This study reveals that an increase in O(2) consumption of 50% resulted in a much lower increase in the renal excretion of oxo(8)dG.

Whole-body degradation rates of transfer-, ribosomal-, and messenger ribonucleic acids and resting metabolic rate in 3- to 18-year-old humans.

Whole-body degradation rates of transfer, ribosomal, and messenger RNA were determined noninvasively in 3-, 6-, 10-, 14-, and 18-y-old female and male subjects (n = 14 per age group per sex) under normal living conditions. The method for determining the RNA degradation rates is based on measuring the renal excretion rates of special RNA catabolites (modified ribonucleosides and nucleobases) by HPLC. Resting metabolic rates were calculated for the same subjects by their body weights using formulas taken from literature. We found high correlations between the degradation rates of the different RNA classes (micromoles per day per kilogram body weight) and the resting metabolic rate (kilojoules per day per kilogram body weight): in females (n = 70), r = 0.75-0.82 and in males (n = 70), r = 0.68-0.79 (p<0.0001). We conclude that a causal relationship exists between the whole-body degradation rates of the different RNA classes and the resting metabolic rate. Therefore, in healthy subjects noninvasive determinations of RNA degradation rates could be very useful to assess the resting metabolic rate.

Development of scores to measure the effects of nutrition counselling on the overall diet: A pilot study in children and adolescents.

An intervention study by documented dietary counselling was carried out in a sample of 9 children and adolescents (12-15 years) living in a full-time institution in Dortmund. Three weighed dietary records were collected over 3-7 days, one before and one after each of two individual nutrition counselling sessions, which were based on the recommended intake of food groups defined by the Optimized Mixed Diet (OMD), a quantitative preventive dietary conception for children and adolescents. As univariate dietary parameters (e.g., cholesterol intake), which are often used to show the effectiveness of nutrition counselling, do not take into account the multivariate complexitiy of nutrition, we developed 3 multivariate scores to measure the effectiveness of nutrition counselling. They are defined as: Recommended Food group change Score (RFS): Average change in the amounts of the deviations (%) from the reference food groups values (OMD = 100 %) before and after counselling taking into account the aim (eat mor/less) of the counselling session, exclusively based on the food groups addressed during counselling. Total Food group change Score (TFS): Average change in the amounts of the deviations (%) from the reference food group values (OMD = 100 %) before and after counselling based on all food groups consumed. Nutrient Improvement Score (NIS): Average change in the negative deviations (%) of 8 vitamins and 8 minerals from the German reference values for nutrient intake (Deutsche Gesellschaft für Ernährung (DGE) = 100 %) before and after counselling. On average, the intakes of the food groups mentioned during the first counselling session improved considerably (RFS = +36 %), the change in the intake of all food groups was small (TFS = +6 %) and the nutrient intakes did not improve (NIS = 0 %). From the second counselling session the values of the RFS was +10 %, of the TFS was +6% and of the NIS +3 %. This means that the success of counselling on one dietary criterion does not guarantee success on others. Our food and nutrient based scores together with a detailed food intake assessment give an example of multivariate measurements of nutrition counselling outcomes.

Fruit juice consumption and the prevalence of obesity and short stature in german preschool children: results of the DONALD Study. Dortmund Nutritional and Anthropometrical Longitudinally Designed.

BACKGROUND: In recent years, a possible association between excessive consumption of fruit juice (> or =12 fl oz per day) and short stature and/or obesity has been discussed. The association among the consumption of fruit juice, anthropometric indices, and the overall diet was examined during a 3-year period in a sample of healthy preschool children participating in the Dortmund Nutritional and Anthropometrical Longitudinally Designed (DONALD) Study. METHODS: Two hundred five children were examined annually at the ages of 3, 4, and 5 years. Dietary intake was calculated from 3-day weighed diet records. Height was measured using a stadiometer. Weight was measured using an electronic scale. RESULTS: Five children consumed excessive fruit juice continually in all three records, 10 children in two records, and 23 children in one record. None of the five children with repeatedly excessive fruit juice consumption was obese or short. Growth velocity, body mass index, and height standard deviation score were not correlated with fruit juice consumption. Consumption of fruit juice was inversely correlated with the consumption of all other beverages and the total consumption of all other food. The intake of protein, fat, and carbohydrates of children consuming excessive fruit juice was closer to the international dietary preventive guidelines than the intake of children consuming low amounts of fruit juice. CONCLUSIONS: In the study sample, even repeatedly excessive fruit juice consumption had no influence on anthropometric indices. The results do not justify a general warning or a general promotion regarding high fruit juice consumption in preschool children's diets.

Vitamin intake of 3- to 36-month-old German infants and children--results of the DONALD-Study.

Infants and young children are a vulnerable group with regard to nutrition. However, there is a lack of information about the dietary composition of healthy German infants and children. Therefore, the intake of vitamins (A, C, E, B1, B2, B6, folate, niacin) was assessed in 354 healthy German infants and children aged 3 to 36 months from 3-day-weighed diet records and compared with German, European and US reference values. Intake of all B-vitamins (B1, B2, B6, folate, niacin) increased during the first 3 years of life, whereas intake of vitamin E decreased. Intake of vitamin A and C varied between age groups. The highest levels of the nutrient densities of most vitamins were found at the end of the first year of life. Depending on the reference values chosen, the vitamin supply of the study population ranged between sufficient and very good. The reported satisfactory intake of vitamins in infants and young children in this study gives rise to the question of whether the current extent of fortification of commercial infant food in Germany is necessary.

Marrow transplantation from unrelated donors for patients with severe aplastic anemia who have failed immunosuppressive therapy.

Allogeneic marrow transplantation offers curative therapy for patients with aplastic anemia. We analyzed retrospective results in 141 patients with severe aplastic anemia who received transplants between 1988 and 1995 from an unrelated volunteer donor identified through the National Marrow Donor Program (NMDP). All patients had failed one or more courses of immunosuppressive therapy. Of the patients, 121 (86%) received a radiation-containing conditioning regimen, and 20 (14%) were given chemotherapy only. Based on serologic human leukocyte antigen (HLA) typing (class I and II), 105 patients (74%) received HLA-matched marrow, and 36 (26%) received marrow mismatched for at least one HLA-A, -B, or -DR antigen. Allele-level (molecular) typing for HLA-DRB1 was available in 108 donor-recipient pairs; 77 patients received DRB -matched and 31 DRB1-mismatched transplants. All but 13% of patients were given a cyclosporine-containing regimen for graft-vs.-host disease (GVHD) prophylaxis, and 45 patients (32%) received marrow that was T cell-depleted. Among 131 evaluable patients, 116 (89%) achieved sustained engraftment and 15 (11%) did not. Among patients with engraftment, acute GVHD of grades II-IV developed in 60 patients (52%) and extensive chronic GVHD in 24 patients at risk (31%). Currently, 51 patients (36%) are surviving at 11-94 months (median 36) after transplantation. All but five have Karnofsky scores > or =80. Patients who received a serologically matched transplant fared somewhat better than did patients given a serologically mismatched transplant p = 0.03). Patients with donors matched by both serology and allele-level DRB1 typing had significantly better survival than DRB1-mismatched patients with 56 vs. 15% surviving at 3 years p = 0.001). Outcome in patients transplanted within 3 years of diagnosis was superior to that among patients transplanted with greater delay. Major causes of death were graft failure, GVHD, and infections. These data suggest that unrelated marrow transplantation offers successful therapy for a proportion of patients who have failed immunosuppressive therapy.

Consumption of fortified food between 1985 and 1996 in 2- to 14-year-old German children and adolescents.

Since the 1980s, fortified food plays an increasing role in food marketing in Germany. However, there is a lack of data concerning fortified food consumption. We therefore evaluated dietary information of the DONALD Study. A total of 2251 3-days weighed records between 1986 and 1996 from 637 different subjects aged between 2 and 14 years (mean: 6.6 years) were evaluated. Food products were defined as fortified if enriched at least with one of the following nutrients: vitamin A (including provitamin A carotenoids), E, B1, B2, B6, C, niacin, folate, calcium, magnesium, potassium, iron or phosphate. Products were grouped in 'Diary products', 'Cereals', 'Beverages', 'Instant Beverages', 'Sweets/biscuits', 'Fats/oils', and 'Beikost' (i.e. dietetic food intended for infants and young children under 4 years). Over the last 11 years almost all children and adolescents consumed fortified food products. Excluding the food group 'Fats/oils' the proportion of consumers of fortified food increased by about 20% between 1986 and 1996. During the same period the consumption rate increased up to five-fold for the food group 'Beverages' and fourfold for 'Cereals'. Since 1988, a relatively constant consumption ratio of 62-68 different fortified products per 100 consumers has been found. 'Beverages' showed the highest food-group-specific diversity. In Germany, vitamins are more often used than minerals to fortify food, whereas vitamin C is the most frequent added nutrient. We found some interesting time trends in the use of vitamins and minerals for fortification with a continuous increase in the use of vitamin C and E. Only vitamin A showed a decrease in use during the study period. Finally, we found a decreasing number of consumers of all fortified products at the end of the study period.

Macronutrient intake of 3- to 36-month-old German infants and children: results of the DONALD Study. Dortmund Nutritional and Anthropometric Longitudinally Designed Study.

The intake of macronutrients (protein, fat, fatty acids, carbohydrates, added sugars, fiber) was assessed in 354 healthy German infants and children aged 3-36 months from 3-day weighed diet records. The intake of protein ranged between 7 and 14% of energy intake. Fat intake decreased from 3 months (breast-fed boys and girls, 48%; formula-fed boys/girls, 41/44%) to 12 months (boys/girls, 33/36%) due to the increasing consumption of commercial weaning foods, and then increased again up to 36 months (boys/girls, 40/43%). Intake of added sugars decreased during the first 12 months and then increased again, but only slightly exceeded the limit of 10%. Intake of dietary fiber was highest at the age of 1 year (boys/girls, 2.7/2.3 g/MJ). The macronutrient intake was in accordance with other German and European surveys, but deviated considerably from the respective recommendations.

Role of unusual amino acid residues in the proximal and distal heme regions of a plant P450, CYP73A1.

CYP73A1 is a typical plant P450 in terms of its function and primary sequence. The enzyme catalyzes the 4-hydroxylation of trans-cinnamic acid, the first oxidative step in the phenylpropanoid pathway. Its primary protein sequence exhibits some particular landmarks which are characteristic of plant P450 enzymes. The most interesting is a proline residue (Pro448), very unusual in animal P450s, just C-terminal to the invariant heme-binding cysteine. To determine the role of this proline, we substituted it with valine, isoleucine, or phenylalanine, residues found in animal P450s, using site-directed mutagenesis. Expression of the wild type and mutants in yeast indicated that replacement of Pro448 led to disruption of the heme-protein interaction, loss of catalytic activity, and either impaired expression or destabilization of the apoprotein. Pro448 is thus essential for the correct insertion of heme in the apoprotein. Another typical feature of CYP73A proteins is the presence of an alanine-alanine motif (Ala306-Ala307) on the presumed N-terminal edge of the cleft in the central part of the I helix. This cleft faces the iron on the distal side of the heme and is proposed to be essential for catalysis. Substitution of each or both Ala306 and Ala307 residues with glycines showed that they are critical for the stability of the protein and influence the positioning of the substrate in the active site. Results are discussed with reference to the structural X-ray data that are available for bacterial P450 proteins.

Underreporting of energy intake in 1 to 18 year old German children and adolescents.

It is generally accepted that self-reported food intakes underestimate habitual energy intake (underreporting). Underreporting is often addressed by computing the ratio of measured energy intake to predicted basal metabolic rate (EI:BMR). We used this ratio to study differences between not plausible records (NPR) and plausible records (PR) according to recalculated cut-off values for EI:BMR ratios (< 0.97 to 1.07; age- and sex-dependent) in cross-sectional data of 1,032 3d weighed diet records of 1 to 18 year old children and adolescents. Underreporting (in 5% of total subjects) was age and sex dependent: about 1% in the 1 to 5 year old children, 2% (3%) in the 6 to 13 year old males (females) and 12% (20%) in the adolescent males (females), respectively. To analyse differences between subgroups with PR vs. NPR we therefore concentrated on the 14 to 18 year olds. Male (female) subjects with NPR vs. PR had a 40% lower total EI: 7.4 MJ/d (5.3 MJ/d) vs. 11.5 MJ/d (8.0 MJ/d), respectively. In both sexes with NPR vs. PR, EI per meal was lower. Females with NPR vs. PR had a higher body mass index (kg:m2), recorded fewer meals per day, and had a shorter time span between the first and last meal per day. Furthermore, females with NPR vs. PR had higher intakes per MJ of water, protein, fiber, sodium, iron, niacin, zinc, and protein in percent of total EI, but a lower intake of added sugars per MJ. Males with NPR vs. PR answered significantly more often that they usually eat more, had a higher water intake per MJ, and a higher Ca:P. The observed differences between groups with PR and NPR indicate different food habits or dietary recording behavior. Therefore, validity in dietary studies cannot be achieved by simply excluding underreporters.

Macronutrient intake of 1 to 18 year old German children and adolescents.

In a sample of 627 healthy German children and adolescents between the age of 1 and 18 years the intake of macronutrients (protein, fat, carbohydrates) and their specific subgroups (animal protein, saturated (SFA), monounsaturated (MUFA) and polyunsaturated fatty acids (PUFA), cholesterol, added sugars, dietary fiber) were assessed from 3d weighed diet records. The medians of the nutrient intake (% of energy) were 13% protein (2/3 animal), 38% fat, 49% carbohydrates, 17% SFA, 16% MUFA, 5% PUFA, 12% added sugars and (per MJ) 34 mg cholesterol, 1.9 g dietary fiber. The macronutrient patterns were almost uniform across the age and sex groups with the exception of lower fat, PUFA, and sugar intakes in the 1 year olds. The findings were almost in accordance with former and current dietary surveys in Germany and neighboring countries. Several findings, particularly the high SFA and low fiber intake, differed considerably from the diet for the prevention of the chronic diseases related to nutrition in western societies which is recommended for this age range. Based on the findings of this study, a preventive dietary concept for German children and adolescents was proposed.

Measured consumption of commercial infant food products in German infants: results from the DONALD study. Dortmund Nutritional and Anthropometrical Longitudinally Designed.

BACKGROUND: Commercial food products intended for infants form an important part of the diet. Such products are defined as special dietetic food by food legislation. However, quantitative consumption data in the context of the current European Community (EC) food regulations have not been available up to now. METHODS: Six hundred eighty 3-day weighed diet records from 3-, 6-, 9-, and 12-month-old infants involved in the DONALD (Dortmund Nutritional and Anthropometrical Longitudinally Designed) Study were evaluated regarding overall and individual consumption of commercial infant food (CIF). Here, CIF was allocated to the food categories of the current EC directives. RESULTS: Four hundred eighteen varieties of infant food were recorded. The total CIF (formulae; beikost [any food or drink other than breast milk or infant and follow-on formulae]) reached percentages of the total food intake (including breast milk) of 51% (47%; 4%), 62% (33%; 29%), 53% (20%; 32%), and 37% (13%; 24%) at the ages of 3, 6, 9 and 12 months, respectively. Approximately 55% (95%) of the 3-month-old infants (range, 6-12 months) consumed some sort of CIF, but the highest amounts were observed at 6 months and the highest numbers of consumers at 9 months. Depending on the definition of "high consumers" of CIF, the individual consumption quantities (in grams per kilogram per day) differed by a maximum of 60% but high consumers were always found in the 6-month-old group. CONCLUSION: The high proportions of CIF in the diet during a critical developmental period call for a guaranteed high nutritional and safety quality of CIF and for realistic data on consumption patterns.