A randomized controlled trial comparing oral and intravenous iron supplementation after Roux-en-Y gastric bypass surgery.

BACKGROUND: Iron deficiency (ID) is one of the most common postoperative deficiencies that may develop after Roux-en-Y gastric bypass (RYGB). The optimal mode of treatment is uncertain. AIM: To compare the efficacy of oral ferrous fumarate (FF), oral ferrous gluconate (FG), and a single intravenous infusion of ferric carboxymaltose (FCM) in women with ID after RYGB. METHODS: Multicenter randomized controlled trial including 120 women with a serum ferritin <20 µg/l during follow-up after RYGB. They were randomized into three groups: 41 patients were treated with FF 200 mg three times a day (total daily dose: 195 mg elemental iron), 39 received FG 695 mg twice a day (total daily dose: 160 mg elemental iron) for three months, and 39 patients were treated with a single intravenous dose of FCM (1000 mg elemental iron). Serum ferritin levels were measured at six weeks, and three, six and twelve months after the start of supplementation. RESULTS: At three months, persistence of ID was observed in 29.4% and 42.4% of the patients treated with FF and FG, respectively, but in none of those treated with FCM (p < 0.001). Over the next nine months, recurrence of ID was observed in 56.5% of patients treated with FF, in 52.9% treated with FG, and in 27.8% of those treated with FCM. Adverse effects were most common during oral treatment. CONCLUSION: In women developing ID after RYGB, a single dose of intravenous FCM is more effective and better tolerated than the standard treatment with either FF or FG. CLINICAL TRIAL REGISTRY NUMBER AND WEBSITE: The study was registered at clinicaltrials.gov under number NCT02271997.

The True Story on Deficiencies After Sleeve Gastrectomy: Results of a Double-Blind RCT.

BACKGROUND: Since a few years, the laparoscopic sleeve gastrectomy (SG) has become the most performed bariatric operation worldwide. However, as with all bariatric procedures, SG also leads to vitamin and mineral deficiencies post-operatively and standard multivitamin supplements are probably not sufficient. OBJECTIVE: The present study evaluates the effectiveness of a specialized multivitamin supplement for SG patients (WLS Optimum 1.0, FitForMe, Rotterdam, the Netherlands), compared to a standard multivitamin supplement (sMVS). DESIGN: A double-blind randomized controlled trial was performed. For 12 months, patients in the intervention group received WLS Optimum, containing elevated doses of multiple vitamins and minerals. Patients in the control group were provided with sMVS, containing 100% of the recommended dietary allowance. RESULTS: In total, 139 patients were available for analysis (WLS Optimum, n = 69; sMVS, n = 70). Intention-to-treat analyses revealed more folic acid deficiencies and higher serum vitamin B1 levels in the WLS Optimum group. Per protocol analyses showed that in patients using WLS Optimum, serum folic acid and vitamin B1 levels were higher, serum PTH levels were lower, and only one patient (2.6%) was anemic compared to 11 patients (17.5%) using a sMVS (p < 0.05 for all). No differences were found in prevalence of deficiencies for iron, vitamin B12, vitamin D, and other vitamins and minerals. CONCLUSIONS: This optimized multivitamin supplement only affected serum levels of folic acid, PTH and vitamin B1, and anemia rates compared to a sMVS. There is a clear need to further optimize multivitamin supplementation for SG patients. Besides, non-compliance with multivitamin supplements remains an important issue that should be dealt with. CLINICAL TRIAL REGISTRY: The study protocol was registered at the clinical trials registry of the National Institutes of Health (ClinicalTrials.gov; identifier NCT01609387).

Adequate Multivitamin Supplementation after Roux-En-Y Gastric Bypass Results in a Decrease of National Health Care Costs: a Cost-Effectiveness Analysis.

INTRODUCTION: Patients with morbid obesity undergoing metabolic surgery are prone to develop vitamin and mineral deficiencies, which may worsen in time. In order to prevent these deficiencies after metabolic surgery, all patients are advised to take daily multivitamin supplementation. The aim of the study was to assess the cost-effectiveness of specially developed multivitamins (WLS Forte®) for metabolic surgery and over-the-counter (standard) multivitamin supplementation (sMVS). METHODS: This cost-effectiveness analysis was preformed alongside an RCT for the Netherlands. Between June 2011 and March 2012, a total of 148 patients were randomized to one tablet daily of either WLS Forte® or sMVS. The patients were followed for 12 months. Data on costs within the health sector and outside the health sector were collected. The primary outcome is financial and logistic advantages, in terms of less patient visits to the outpatient department and the relevant costs to the employer due to absenteeism. RESULTS: In total, 10 (14%) patients in the WLS Forte® group versus 23 (30%) patients in the sMVS group developed a deficiency. The costs for the WLS forte® supplement were €38 versus €23 for sMVS. Additional return visits and associated costs for medical staff were the largest costs, up to 43% in the sMVS group. Total costs for supplementation with sMVS were €243 versus €134 for WLS Forte®. CONCLUSION: Preventing deficiencies with WLS Forte® seem initially more expensive than sMVS. However, treatment with WLS Forte® resulted in less vitamin and mineral deficiencies, which eventually resulted in less overall costs.

Efficacy of oral compared with intramuscular vitamin B-12 supplementation after Roux-en-Y gastric bypass: a randomized controlled trial.

Background: After Roux-en-Y gastric bypass (RYGB), patients often develop a vitamin B-12 deficiency. Objective: Our objective was to investigate whether oral supplementation increases and normalizes low vitamin B-12 concentrations (vitamin B-12 > 200 pmol/L) in RYGB patients as compared to intramuscular injections. Design: A randomized controlled trial in RYGB patients with subnormal serum B-12 concentrations was performed. One group (IM B-12) received bimonthly intramuscular hydroxocobalamin injections (2000 µg as loading dose and 1000 µg at follow-up) for 6 mo. The second group (oral B-12) received daily doses of oral methylcobalamin (1000 µg). Serum vitamin B-12 was determined at baseline (T0) and at 2 (T1), 4 (T2), and 6 mo (T3) after start of treatment. Concentrations of the secondary markers methylmalonic acid (MMA) and homocysteine (Hcy) were measured at T0 and T3. Results: Fifty patients were included and randomized, 27 in IM B-12 and 23 in oral B-12. The median vitamin B-12 concentration at T0 was 175 pmol/L (range: 114-196 pmol/L) for IM B-12 and 167 pmol/L (range: 129-199 pmol/L) for oral B-12. Vitamin B-12 normalized in all individuals, and there was no significant difference in vitamin B-12 between the two groups. MMA and Hcy concentrations decreased significantly after 6 mo within each group (P < 0.001 and P < 0.001 for MMA and P = 0.03 and P = 0.045 for Hcy, respectively). There was no significant difference between the groups at 6 mo for both MMA and Hcy (P = 0.53 and P = 0.79). Conclusion: The efficacy of oral vitamin B-12 supplementation was similar to that of hydroxocobalamin injections in the present study. Oral supplementation can be used as an alternative to hydroxocobalamin injections to treat RYGB patients with low values of serum vitamin B-12. This trial was registered at clinicaltrials.gov as NCT02270749.

Do specialized bariatric multivitamins lower deficiencies after RYGB?

BACKGROUND: One of the side effects of bariatric surgery is the risk of vitamin and mineral deficiencies. Vitamin B12, vitamin D, folate, and iron deficiencies are especially common among Roux-en-Y gastric bypass patients. OBJECTIVE: To examine the effectiveness of a specialized multivitamin supplement for Roux-en-Y gastric bypass patients on deficiencies the first 3 years postoperatively, retrospectively in a large, prospectively collected cohort. SETTING: Large specialized bariatric hospital. RESULTS: One thousand one hundred sixty patients were included, 883 users and 258 who were nonusers of the specialized multivitamin. Patient characteristics and total weight were comparable. Higher serum concentrations of ferritin (124.7 ± 96.2 µg/L versus 106.0 ± 83.0 µg/L, P = .016), vitamin B12 (347.3 ± 145.1 pmol/L versus 276.8 ± 131.4 pmol/L, P<.001), folic acid (34.9 ± 9.6 nmol/L versus 25.4 ± 10.7 nmol/L, P<.001), and vitamin D (98.4 ± 28.7 nmol/L versus 90.0 ± 34.5 nmol/L, P = .002) were observed in users compared with nonusers after 1 year. Less new deficiencies were found for ferritin (1% versus 4%, P = .029), vitamin B12 (9% versus 23%, P<.001), and vitamin D (0% versus 4%, P<.001) in users compared with nonusers. Two and 3 years after the surgery these findings remained almost identical. CONCLUSIONS: The use of specialized multivitamin supplements resulted in less deficiencies of vitamin B12, vitamin D, folic acid, and ferritin. The study showed that Roux-en-Y gastric bypass patients benefited from the specialized multivitamin supplements and it should be advised to this patient group.

Changes in Iron Absorption After Roux-en-Y Gastric Bypass.

INTRODUCTION: Iron deficiency is one of the most common deficiencies that may occur after Roux-en-Y gastric bypass (RYGB). Little is known about the optimal treatment of post-RYGB iron deficiency. AIM: The aim of this study is to evaluate the changes in iron absorption characteristics after RYGB for two oral iron formulations, one presented in tablet form and one as in the form of a solution. METHOD: Iron absorption in 24 obese women was studied before and 1 month after RYGB. Twelve patients were tested with a single dose of 600 mg ferrous fumarate in tablet form (195 mg of elementary iron, group 1), and 12 patients received a single dose of 1390 mg ferrous gluconate as a solution (160 mg of elementary iron, group 2). Serum iron levels were measured before (T0) and every hour after ingestion of the supplement (T1-T9). RESULTS: Before surgery, iron absorption was similar for the two supplements (P = 0.71). However, RYGB was associated with a decrease in fumarate iron absorption (P < 0.001) but did not affect gluconate iron absorption (P = 0.13). Postoperative absorption of fumarate iron was significantly lower than gluconate iron at T1 (P < 0.05), but the overall difference over 9 h did not reach statistical significance (P = 0.53). CONCLUSION: RYGB adversely affects the absorption of ferrous fumarate tablets but not that of solubilized ferrous gluconate. A solubilized supplement is therefore preferred as the supplement of first choice after RYGB.

Long-term nutritional status in patients following Roux-en-Y gastric bypass surgery.

BACKGROUND & AIMS: Roux-en-Y gastric bypass (RYGB) is an effective treatment for obesity. However, it also leads to multiple nutritional deficiencies. Much is known about the short term prevalence, but hardly any long term data is available on deficiencies. The aim of this study was to assess the long term outcome of nutritional status after RYGB. METHODS: We performed a retrospective analysis of prospectively collected data obtained from 51 morbidly obese patients who underwent a primary laparoscopic RYGB. Primary outcomes were iron, vitamin B12 and vitamin D deficiencies. Secondary outcomes were deficiencies of other vitamins and minerals and compliance of the patients to multivitamin use. RESULTS: The mean follow-up was 81 ± 27 months. A total of 35%, 16% and 55% of the patients had deficiencies for iron, vitamin B12 and vitamin D respectively. Sixty-nine percent of patients used a (nonspecific) multivitamin supplement on a daily basis. Patients with multivitamin usage had a lower rate of iron deficiency (26% vs. 56%, p = 0.034), vitamin B12 (11% vs. 25%, p = 0.46) and vitamin D (46% vs. 75%, p = 0.07), compared to non-compliant patients. CONCLUSIONS: Nutritional deficiencies are common after a RYGB operation. Therefore, strict follow-up by a bariatric surgeon, endocrinologist or general practitioner is required, both short and long term.

Treatment of Vitamin and Mineral Deficiencies After Biliopancreatic Diversion With or Without Duodenal Switch: a Major Challenge.

BACKGROUND: Vitamin and mineral deficiencies are a major concern after biliopancreatic diversion (BPD) and BPD with duodenal switch (BPD/DS). Evidence-based guidelines how to prevent or how to treat deficiencies in these patients are currently lacking. The aim of the current study is to give an overview of postsurgical deficiencies and how to prevent and treat these deficiencies. METHODS: Retrospective evaluation of a 1-year structured monitoring and treatment schedule for various deficiencies in 34 patients after BPD or BPD/DS. RESULTS: Patients were introduced into the program 12-90 months after surgery. Vitamin B1, B6, B9, and B12 deficiencies could be prevented by mean daily doses of 2.75 mg, 980 µg, 600 µg, and 350 µg, respectively. However, many patients continued to develop deficiencies of vitamin A, D, iron, calcium, and zinc despite major dose adjustments. Current observations suggest that at least total daily doses of 200 mg Fe in premenopausal women and 100 mg in men, 100 mg of Zinc, 3000 mg of calcium, and weekly doses of at least 50,000 IU solubilized vitamin A and vitamin D are needed to prevent the occurrence of major deficiencies. CONCLUSION: Exceptionally high supplementation doses are needed to prevent and treat vitamin and mineral deficiencies in patients after BPD or BPD/DS. Further refinement and simplification of treatment schedules is needed. Focus on improvement of compliance to treatment is recommended.

Loose and frequent stools and PTH levels are positively correlated post-gastric bypass surgery due to less efficient intestinal calcium absorption.

BACKGROUND: After Roux-en-Y gastric bypass, calcium and vitamin D deficiencies are frequently reported. In the presence of adequate vitamin D levels, calcium deficiency is caused by a lower efficacy of the intestinal calcium transport. OBJECTIVE: To investigate whether the use of a simple clinical score quantifying bowel habits (fecal score [FS]) correlates with the degree of secondary hyperparathyroidism that arises to compensate for calcium deficiency postsurgery. SETTING: Large peripheral hospital. METHODS: Seventy-five patients supplemented with calcium and vitamin D were prospectively studied before and 6 and 12 months after Roux-en-Y gastric bypass. FS, calcium (mmol/L), phosphate (mmol/L), magnesium (mmol/L), vitamin D (nmol/L), and parathyroid hormone (PTH; pmol/L) were measured in each patient. RESULTS: Mean body mass index was 44.7±5.4 kg/m2 preoperatively and decreased to 34.3±5.0 kg/m2 at 6 months and 30.8±4.8 kg/m2 at 12 months, corresponding to a total weight loss of 23.2±5.9% and 30.9±8.3% respectively. There were no significant changes in serum calcium levels. Mean PTH levels rose from 3.5 pmol/L at baseline to 4.1 pmol/L at 6 months (P = .01) and to 4.9 pmol/L at 12 months (P<.001). Nine patients (12%) had increased PTH levels at 6 months, and 14 patients (19%) had increased PTH levels at 12 months. A significant positive correlation between FS and PTH at 12 months was found, which persisted after adjusting for vitamin D levels. CONCLUSION: FS is positively correlated with secondary hyperparathyroidism using vitamin D-adjusted PTH levels as a biochemical marker. The present study in humans confirms the relation reported in animal studies. These results emphasize that managing stool habits are important after bariatric surgery.

An optimized multivitamin supplement lowers the number of vitamin and mineral deficiencies three years after Roux-en-Y gastric bypass: a cohort study.

BACKGROUND: Vitamin and mineral deficiencies are common after Roux-en-Y gastric bypass (RYGB) surgery. In particular, inadequate serum concentrations of ferritin and vitamin B12 have been found in 11% and 23% (respectively) of patients using a standard multivitamin supplement (sMVS) 1 year after RYGB. OBJECTIVE: To evaluate the effectiveness and safety of Weight Loss Surgery (WLS) Forte® (a pharmaceutical-grade, optimized multivitamin supplement) compared with an sMVS and a control group (nonuser) 3 years after RYGB. SETTING: General hospital specialized in bariatric surgery. METHODS: A follow-up cohort study of a triple-blind randomized, controlled clinical trial. RESULTS: At baseline 148 patients were enrolled (74 [50%] in the sMVS group and 74 [50%] in the WLS Forte group). After a mean follow-up of 36 months, 11 (7%) patients were lost to follow-up, of whom 2 were secondary to death. At the end of the study, 11 (17%) patients in the WLS Forte and 17 (24%) in the sMVS group stopped using a supplement. In addition, 64 (47%) patients were using WLS Forte and 45 (33%) patients a sMVS. Patient characteristics and follow-up length were comparable between the groups. Significantly more patients were diagnosed with anemia (16% versus 3% [P = .021]), a ferritin deficiency (14% versus 3% [P = .043]), and a zinc deficiency (8% versus 0% [P = .033]) in the sMVS group compared with WLS Forte. Five patients developed a vitamin B12 deficiency while using WLS Forte, versus 15 of sMVS users (P = .001). No adverse events occurred that were related to supplement use. CONCLUSION: At 3 years postoperative of RYGB, an optimized multivitamin supplement (WLS Forte) was more effective in reducing anemia and ferritin, vitamin B12, and zinc deficiencies compared with a standard supplement and control.

Management of vitamin K deficiency after biliopancreatic diversion with or without duodenal switch.

BACKGROUND: Reduced serum vitamin K levels are frequently observed after biliopancreatic diversion (BPD) and BPD with duodenal switch (BPD/DS). The criteria for treatment are not precisely defined. OBJECTIVES: To assess the effects of standardized vitamin K supplementation in patients who develop vitamin K deficiency after BPD or BPD/DS. SETTING: Teaching hospital specializing in bariatric surgery. METHODS: Serum vitamin K levels, clotting times, and vitamin K-dependent coagulation factors were measured after an overnight fast at baseline and then at 4 days and 1, 4, and 52 weeks after the start of vitamin K supplementation in 10 consecutive patients who had developed severe vitamin K deficiency after BPD or BPD/DS. Vitamin K was administered in a dose of 5 mg/d for 1 week, followed by a maintenance dose of 5 mg once a week. RESULTS: At baseline, all patients had serum vitamin K1 levels below the limit of detection, but none reported symptoms of easy bleeding. Minor prolongation of the prothrombin time and minimal decreases of some coagulation factors were observed in a minority of patients. During the first week of vitamin K loading, median serum vitamin K1 levels rose into the high normal range. During maintenance treatment, median vitamin K1 levels settled in the low normal range. CONCLUSION: Vitamin K1 deficiency in patients with BPD or BPD/DS is not commonly associated with bleeding or clinically relevant decreases in coagulation factor activity. We hypothesize that vitamin K2 production in the large intestine is usually sufficient to compensate for vitamin K1 deficiency and to maintain total liver vitamin K stores within the range required for (near) normal coagulation factor production.

Vitamin and Mineral Deficiencies After Biliopancreatic Diversion and Biliopancreatic Diversion with Duodenal Switch--the Rule Rather than the Exception.

INTRODUCTION: Malabsorptive bariatric procedures, like the biliopancreatic diversion (BPD) and BPD with duodenal switch (BPD/DS), have excellent results in terms of weight loss. However, these malabsorptive techniques are associated with severe malnutrition and vitamin deficiencies. The aim of this study was to evaluate the vitamin and mineral status after BPD and BPD/DS in the long term. METHODS: All patients who underwent BPD or BPD/DS were selected and invited for an additional follow-up (FU) visit, including blood sampling for vitamin and mineral levels. RESULTS: Forty patients completed the blood sampling with a median FU of 42 (range 12-90) months. At that time, all patients used some kind of supplementation. However, 93 % of all patients were diagnosed with a deficiency. There were no significant differences in mean serum level vitamins and minerals between BPD and BPD/DS. Forty-three per cent of the patients were anaemic, and 40 % had an iron deficiency (ID). High deficiency rates for fat-soluble vitamins were present: vitamin A in 28 %, vitamin D in 60 %, vitamin E in 10 % and vitamin K in 60 % of the patients. Hypervitaminosis was found in 43 % of the patients for vitamin B1 and in 50 % for vitamin B6. CONCLUSION: High numbers of vitamin and mineral deficiencies were found after BPD and BPD/DS despite vitamin supplementation. Anaemia, ID and deficiencies for fat-soluble vitamins are frequently diagnosed. Repeated monitoring is necessary to detect deficiencies at an early stage. Taking all of this into consideration, a stringent multivitamin supplementation regimen should be implemented after malabsorptive procedures.

Optimization of vitamin suppletion after Roux-en-Y gastric bypass surgery can lower postoperative deficiencies: a randomized controlled trial.

Iron, vitamin B12, and folic acid deficiencies are among the most common deficiencies occurring after laparoscopic Roux-en-Y gastric bypass (LRYGB). The present study evaluates the effectiveness of a specially designed multivitamin supplement (WLS Forte, FitForMe, Rotterdam, the Netherlands) specifically developed for LRYGB patients.A triple-blind, randomized, 12-month study was conducted comparing WLS forte with a standard multivitamin supplement (sMVS) containing approximately 100% of the recommended daily allowance (RDA) for iron, vitamin B12, and folic acid. WLS Forte contains vitamin B12 14000% RDA, iron 500% RDA, and folic acid 300% RDA.In total, 148 patients (74 in each group) underwent a LRYGB procedure. Baseline characteristics were similar for both groups. Per protocol analysis demonstrated that sMVS treatment was associated with a decline in ferritin (-24.4 ±â€Š70.1 µg/L) and vitamin B12 (-45.9 ±â€Š150.3 pmol/L) over 12 months, whereas in WLS Forte patients, ferritin remained stable (+3.2 ±â€Š93.2 µg/L) and vitamin B12 increased significantly (+55.1 ±â€Š144.2 pmol/L). The number of patients developing ferritin or vitamin B12 deficiency was significantly lower with WLS Forte compared with sMVS (P < 0.05). Iron deficiency (ID) was reduced by 88% after WLS Forte compared with sMVS. Adverse events related to supplement use did not occur.An optimized multivitamin supplement is safe and reduces the development of iron and vitamin B12 deficiencies after LRYGB.

The gastric sleeve: losing weight as fast as micronutrients?

BACKGROUND: Recently, the laparoscopic sleeve gastrectomy (LSG) has become popular as a single-stage procedure for the treatment of morbid obesity and its co-morbidities. However, the incidence of micronutrient deficiencies after LSG have hardly been researched. METHODS: From January 2005 to October 2008, 60 patients underwent LSG. All patients were instructed to take daily vitamin supplements. Patients were tested for micronutrient deficiencies 6 and 12 months after surgery. RESULTS: Anemia was diagnosed in 14 (26%) patients. Iron, folic acid, and vitamin B12 deficiency was found in 23 (43%), eight (15%), and five (9%) patients, respectively. Vitamin D and albumin deficiency was diagnosed in 21 (39%) and eight (15%) patients. Hypervitaminosis A, B1, and B6 were diagnosed in 26 (48%), 17 (31%), and 13 (30%) patients, respectively. CONCLUSIONS: Due to inadequate intake and uptake of micronutrients, patients who underwent LSG are at serious risk for developing micronutrient deficiencies. Moreover, some vitamins seem to increase to chronic elevated levels with possible complications in the long-term. Multivitamins and calcium tablets should be regarded only as a minimum and supplements especially for iron, vitamin B12, vitamin D, and calcium should be added to this regimen based on regular blood testing.