A randomized trial of vitamin D3 supplementation in children: dose-response effects on vitamin D metabolites and calcium absorption.

CONTEXT: Changes in serum vitamin D metabolites and calcium absorption with varying doses of oral vitamin D3 in healthy children are unknown. OBJECTIVE: Our objective was to examine the dose-response effects of supplemental vitamin D3 on serum vitamin D metabolites and calcium absorption in children living at two U.S. latitudes. DESIGN: Black and white children (n = 323) participated in a multisite (U.S. latitudes 34° N and 40° N), triple-masked trial. Children were randomized to receive oral vitamin D3 (0, 400, 1000, 2000, and 4000 IU/d) and were sampled over 12 weeks in winter. Serum 25-hydroxyvitamin D (25(OH)D) and 1,25-dihydroxyvitamin D (1,25(OH)2D) were measured using RIA and intact PTH (iPTH) by immunoradiometric assay. Fractional calcium absorption was determined from an oral stable isotope 44Ca (5 mg) in a 150-mg calcium meal. Nonlinear and linear regression models were fit for vitamin D metabolites, iPTH, and calcium absorption. RESULTS: The mean baseline 25(OH)D value for the entire sample was 70.0 nmol/L. Increases in 25(OH)D depended on dose with 12-week changes ranging from -10 nmol/L for placebo to 76 nmol/L for 4000 IU. Larger 25(OH)D gains were observed for whites vs blacks at the highest dose (P < .01). Gains for 1,25(OH)2D were not significant (P = .07), and decreases in iPTH were not dose-dependent. There was no dose effect of vitamin D on fractional calcium absorption when adjusted for pill compliance, race, sex, or baseline 25(OH)D. CONCLUSION: Large increases in serum 25(OH)D with vitamin D3 supplementation did not increase calcium absorption in healthy children living at 2 different latitudes. Supplementation with 400 IU/d was sufficient to maintain wintertime 25(OH)D concentrations in healthy black, but not white, children.

[Ethnicity and vitamin D]. / Ethnicité et vitamine D.

Cohort studies, mainly US, show that vitamin D deficiency is more common in African-American population. Social and environmental factors play a role but the difference in skin color is essential. Despite low 25-hydroxyvitamin D concentrations, a lower risk of fragility or fracture exists in these populations. Vitamin D deficiency is a contributing factor in many chronic diseases. There is a relationship between vitamin D deficiencies, progression of chronic kidney disease and increased relative risk of mortality. If the ethnicity of patients is now taken into account to estimate renal function, probably specific recommendations for vitamin D deficiency are needed.

Mixture of ferric sodium ethylenediaminetetraacetate (NaFeEDTA) and ferrous sulfate: an effective iron fortificant for complementary foods for young Chinese children.

BACKGROUND: Ferric sodium ethylenediaminetetraacetate (NaFeEDTA) enhances iron absorption in the presence of phytate. However, the amount of NaFeEDTA that would have to be added to a complementary food to provide the necessary intake of iron for an infant or young child if NaFeEDTA were the sole iron fortificant exceeds the Acceptable Daily Intake (ADI) of EDTA for this age group. EDTA increases iron absorption at a molar ratio EDTA:iron of less than 1:1. OBJECTIVE: To determine whether iron absorption is enhanced with a mixture offerrous sulfate (FeSO4) and NaFeEDTA. METHODS: Two studies with a crossover design were conducted in separate groups of 14 and 15 children aged 24 to 31 months. A complementary food consisting of millet porridge with cabbage, tofu, and pork-filled wheat flour dumplings was fortified with 2 mg iron as either FeSO4 or NaFeEDTA (study 1) or 4 mg iron as FeSO4 or a mixture of 2 mg each of FeSO4 and NaFeEDTA (study 2). Iron absorption was determined based on erythrocyte incorporation of stable iron isotopes. RESULTS: In study 1, the geometric mean (± SD) iron absorption was 8.0% (3.1, 20.8) and 9.2% (3.1, 27.0) from food fortified with FeSO4 and NaFeEDTA, respectively. In study 2, iron absorption was significantly higher from food fortified with 4 mg iron as 1:1 mixture of FeSO4/NaFeEDTA than from food fortified with FeSO4; the geometric mean iron absorption was 6.4% (3.0, 13.5) and 4.1% (1.9, 8.9), respectively. CONCLUSIONS: The enhancing effect of EDTA on iron absorption is less strong in composite meals containing enhancers; nevertheless, the equal mixture of FeSO4 and NaFeEDTA significantly enhanced iron absorption and can be a strategy to ensure adequate iron absorption from phytate-containing complementary foods.

Population pharmacokinetics of steady-state carbamazepine in Egyptian epilepsy patients.

WHAT IS KNOWN AND OBJECTIVE: Individualization of carbamazepine (CBZ) dosage regimen in patients with epilepsy based on based on therapeutic drug monitoring (TDM) followed by estimation of pharmacokinetic (PK) parameters can help in better control of epilepsy. Our objective was to establish a population (POP) PK model of CBZ for Egyptian adult and pediatric patients with epilepsy. METHOD: Single steady-state (SS) trough plasma concentrations of CBZ were available for 302 patients with epilepsy (55·6% men and 44·4% women) who were categorized as children (n = 118) and adults (n = 184) with mean age (years) ± SD of 10·6 ± 4·8 and 29·4 ± 9·9, respectively. Carbamazepine was given as an oral suspension (n = 19) or controlled release tablet (n = 283) with average dose of 15·0 ± 7·8 mg/kg per day. A one-compartment model with first-order absorption and elimination for SS conditions (ADVAN2, SS2, TRANS2) was applied using NONMEM 6.2. Separate absorption rate constants were modelled for the two formulations. The mean POP CL, its intersubject variability (ISV), as well as residual error of CBZ concentration were estimated. RESULTS AND DISCUSSION: The POP estimate for CL was 3·5 L/h with coefficient of variation value of 2·6%, which was consistent with literature data. The ISV on CL was 44·5%. The POP PK model was validated by bootstrap re-sampling, and the individual estimates were within the 95% CI of the bootstrap results. Different covariates that might affect CBZ CL have been evaluated but the limited number of samples per individual prevented precise covariate analysis. WHAT IS NEW AND CONCLUSION: The POP PK model we have developed for CBZ shows good predictive performance in Egyptian adult and pediatric patients with epilepsy. Another PK study to better define the effect of different covariates would improve on the model for dosage individualization.

The change in conjugated linoleic acid concentration in blood of Japanese fed a conjugated linoleic acid diet.

Conjugated linoleic acid (CLA) is a collective term used for fatty acids with a conjugated double bond that are geometrical and positional isomers of linoleic acid. Anti-obesity and anti-cancer properties, an immunopotentiation effect, and promotion of bone formation by CLA have been shown in cell culture and animal studies. A mixture of 9c11t- and 10t12c-CLA is now used as a health food supplement after testing in clinical trials. These trials focused on improvement of lipid metabolism by CLA, whereas few studies have examined absorption and metabolism of CLA in humans. In addition, there is no report concerning absorption and metabolism of CLA in Japanese. This study was designed to examine CLA concentration in blood, the elimination rate of CLA, and metabolic differences between 9c11t-CLA and 10t12c-CLA in blood in Japanese who ingested CLA (about 2 g/d, equal weights of 9c11t-CLA and 10t12c-CLA) for 3 wk. Blood samples were collected 1 wk before the 3-wk period, on the first and last days of the period, and 1 wk after the end of the period, and the CLA concentration and distribution in blood were investigated. The CLA concentration in blood was significantly increased by CLA ingestion and reached 36 µmol/L. The CLA concentration in blood one week after the intake period was significantly lower than that at the end of CLA intake. The 10t12c-CLA level in plasma decreased faster than that of 9c11t-CLA. This suggests faster metabolism (fatty acid ß oxidation) of 10t12c-CLA compared with 9c11t-CLA.