Effect of a Monthly High Dose of Vitamin D3 on Bariatric Surgery Patients

Phase 1

Completed

• Conditions: Vitamin D Deficiency; Morbid Obesity
• Interventions: Dietary Supplement: vitamin D; Dietary Supplement: vitamin D3 (Replesta)

• Registration Number: NCT02477956
• Lead Sponsor: Texas Tech University

Brief Summary

Bariatric surgery patients tend to have malabsorption of many micronutrients such as B12, Iron and vitamin D postoperative. So in this study, a monthly high dose of vitamin D3 is giving to patients with their routine supplements and followed up for 6 months.

Hypothesis:Bariatric surgery subjects taking monthly high dose cholecalciferol supplements in addition to the standard vitamin D protocol will have a significant rise in serum vitamin D levels compared to the subjects taking only the usual vitamin D protocol.

Detailed Description

Sun exposure and supplement use questionnaire:

A registered dietitian asked each subject for information on sun exposure, vitamins, medications, and any other supplement usage before each blood sample was taken.

Lab analysis included serum hydroxy vitamin D levels pre and 3 months postoperative.

Descriptive statistics which include both the means and standard deviations were calculated on the study variables. A paired sample t-test was used to determine if there was a significant difference in mean values pre and post vitamin D supplementation. An independent sample t-test was used to assess for significant differences in group (control vs. vitamin D supplement) means. A p-value \< 0.05 was considered statistically significant. Statistical analyses were done using SPSS Version 21 (SPSS, Chicago, III, USA).

Study Timeline

• Study Start: 2012-11
• Primary Completion: 2013-11
• Study Completion: 2013-12
• Study First Submitted: 2014-05-12
• Status Verified: 2015-06
• Study First Submitted QC: 2015-06-22
• Last Update Submitted: 2015-06-22
• Study First Posted: 2015-06-23
• Last Update Posted: 2015-06-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 31

Inclusion Criteria

• morbidly obese and eligible for bariatric surgery

Exclusion Criteria

• under 18 and over 60 years of age
• elevated serum vitamin D and calcium
• pregnant and lactating women

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control	vitamin D	group of subjects taking the standard vitamin D
vitamin D3	vitamin D3 (Replesta)	subjects taking the standard vitamin D protocol with added monthly high dose cholecalciferol of 100,000 IU cholecalciferol

Primary Outcome Measures

Name	Time	Method
Impact of monthly high dose oral cholecalciferol on serum 25 hydroxy vitamin D levels in bariatric surgery subjects	one year	To determine if there is a significant difference in mean serum vitamin D levels in the group of subjects taking the standard vitamin D protocol compared to subjects taking the standard vitamin D protocol with added monthly high dose cholecalciferol after bariatric surgery. This outcome measure is done by analysis of serum 25-OH vitamin D levels.

Trial Locations

Locations (1)

Texas Tech University; 🇺🇸 Lubbock, Texas, United States