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

June 22, 2015 updated by: Texas Tech University

Impact of Monthly High Dose Oral Cholecalciferol on Serum 25 Hydroxy Vitamin D Levels in Bariatric Surgery Subjects

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

31

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Texas
      • Lubbock, Texas, United States, 79405
        • Texas Tech University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: vitamin D3
subjects taking the standard vitamin D protocol with added monthly high dose cholecalciferol of 100,000 IU cholecalciferol
Dietary supplement: vitamin D3 (Replesta)
vitamin D group receive 2 replesta tablets (100,000 IU/month) of cholecalciferol.
Other Names:
  • Replesta
Active Comparator: Control
group of subjects taking the standard vitamin D
Dietary supplement: vitamin D

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Impact of monthly high dose oral cholecalciferol on serum 25 hydroxy vitamin D levels in bariatric surgery subjects
Time Frame: 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.
one year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Texas Tech University

Investigators

  • Principal Investigator: David Syn, MD, Texas Tech University Health Sciences Center
  • Study Director: Mallory Boylan, PhD, Texas Tech University
  • Study Chair: Hadil Subih, PhD, Texas Tech University
  • Study Chair: Shannon Owens, PhD, Texas Tech University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2012

Primary Completion (Actual)

November 1, 2013

Study Completion (Actual)

December 1, 2013

Study Registration Dates

First Submitted

May 12, 2014

First Submitted That Met QC Criteria

June 22, 2015

First Posted (Estimate)

June 23, 2015

Study Record Updates

Last Update Posted (Estimate)

June 23, 2015

Last Update Submitted That Met QC Criteria

June 22, 2015

Last Verified

June 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Highly dose of vitamin D3

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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