Vitamin D 3 Loading Is Superior to Conventional Supplementation After Weight Loss Surgery in Vitamin D-Deficient Morbidly Obese Patients: a Double-Blind Randomized Placebo-Controlled Trial

Obes Surg. 2017 May;27(5):1196-1207. doi: 10.1007/s11695-016-2437-0.

Abstract

Background: Bariatric patients often suffer from vitamin D deficiency (VDD), and both, morbid obesity and VDD, are related to non-alcoholic fatty liver disease. However, limited data are available regarding best strategies for treating VDD, particularly, in bariatric patients undergoing omega-loop gastric bypass (OLGB). Therefore, we examined the efficacy and safety of a forced vitamin D dosing regimen and intervention effects in liver fibrotic patients.

Methods: In this double-blind, randomized, placebo-controlled trial, 50 vitamin D-deficient patients undergoing OLGB were randomly assigned to receive, in the first month postoperatively, oral vitamin D3 (≤3 doses of 100,000 IU; intervention group) or placebo as loading dose (control group) with subsequent maintenance dose (3420 IU/day) in both groups until 6-month visit.

Results: Compared with control group, higher increase of 25(OH)D (67.9 (21.1) vs. 55.7 nmol/L (21.1); p = 0.049) with lower prevalence of secondary hyperparathyroidism (10 vs. 24 %; p = 0.045) was observed in intervention group. No (serious) adverse events related to study medication were found. The loading dose regimen was more effective in increasing 25(OH)D in patients with significant liver fibrosis while this was not the case for conventional supplementation (placebo with maintenance dose) (71.5 (20.5) vs. 22.5 nmol/L (13.8); p = 0.022; n = 14).

Conclusions: Our findings indicate that a high vitamin D3 loading dose, in the first month postoperatively, with subsequent maintenance dose is effective and safe in achieving higher vitamin D concentrations in OLGB patients. Unexpectedly, it is more effective in patients with significant liver fibrosis which is of potentially high clinical relevance and requires further investigation.

Trial registration: ClinicalTrials.gov NCT02092376.

Keywords: Gastric bypass; Liver fibrosis; Obesity; Omega-loop gastric bypass; Secondary hyperparathyroidism; Vitamin D; Vitamin D supplementation; Weight loss.

Publication types

  • Randomized Controlled Trial

MeSH terms

  • Adult
  • Cholecalciferol / administration & dosage*
  • Dietary Supplements
  • Double-Blind Method
  • Female
  • Gastric Bypass*
  • Humans
  • Hyperparathyroidism, Secondary / complications
  • Liver Cirrhosis / complications
  • Male
  • Middle Aged
  • Non-alcoholic Fatty Liver Disease / complications
  • Obesity, Morbid / complications*
  • Obesity, Morbid / surgery
  • Postoperative Period
  • Prevalence
  • Vitamin D / therapeutic use
  • Vitamin D Deficiency / complications*
  • Vitamin D Deficiency / drug therapy
  • Vitamins / administration & dosage*
  • Weight Loss

Substances

  • Vitamins
  • Vitamin D
  • Cholecalciferol

Associated data

  • EudraCT/2013-003546-16
  • ClinicalTrials.gov/NCT02092376