Back to resultsEffect of a Monthly High Dose of Vitamin D3 on Bariatric Surgery Patients
Primary Purpose
Morbid Obesity, Vitamin D Deficiency
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
vitamin D3 (Replesta)
vitamin D
Sponsored by
About this trial
This is an interventional treatment trial for Morbid Obesity focused on measuring vitamin D, obesity, bariatric surgery
Eligibility Criteria
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
Sites / Locations
- Texas Tech University
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
vitamin D3
Control
Arm Description
subjects taking the standard vitamin D protocol with added monthly high dose cholecalciferol of 100,000 IU cholecalciferol
group of subjects taking the standard vitamin D
Outcomes
Primary Outcome Measures
Impact of monthly high dose oral cholecalciferol on serum 25 hydroxy vitamin D levels in bariatric surgery subjects
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.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02477956
Brief Title
Effect of a Monthly High Dose of Vitamin D3 on Bariatric Surgery Patients
Official Title
Impact of Monthly High Dose Oral Cholecalciferol on Serum 25 Hydroxy Vitamin D Levels in Bariatric Surgery Subjects
Study Type
Interventional
2. Study Status
Record Verification Date
June 2015
Overall Recruitment Status
Completed
Study Start Date
November 2012 (undefined)
Primary Completion Date
November 2013 (Actual)
Study Completion Date
December 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Texas Tech University
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Morbid Obesity, Vitamin D Deficiency
Keywords
vitamin D, obesity, bariatric surgery
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
31 (Actual)
8. Arms, Groups, and Interventions
Arm Title
vitamin D3
Arm Type
Experimental
Arm Description
subjects taking the standard vitamin D protocol with added monthly high dose cholecalciferol of 100,000 IU cholecalciferol
Arm Title
Control
Arm Type
Active Comparator
Arm Description
group of subjects taking the standard vitamin D
Intervention Type
Dietary Supplement
Intervention Name(s)
vitamin D3 (Replesta)
Other Intervention Name(s)
Replesta
Intervention Description
vitamin D group receive 2 replesta tablets (100,000 IU/month) of cholecalciferol.
Intervention Type
Dietary Supplement
Intervention Name(s)
vitamin D
Primary Outcome Measure Information:
Title
Impact of monthly high dose oral cholecalciferol on serum 25 hydroxy vitamin D levels in bariatric surgery subjects
Description
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.
Time Frame
one year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David Syn, MD
Organizational Affiliation
Texas Tech University Health Sciences Center
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Mallory Boylan, PhD
Organizational Affiliation
Texas Tech University
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Hadil Subih, PhD
Organizational Affiliation
Texas Tech University
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Shannon Owens, PhD
Organizational Affiliation
Texas Tech University
Official's Role
Study Chair
Facility Information:
Facility Name
Texas Tech University
City
Lubbock
State/Province
Texas
ZIP/Postal Code
79405
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Effect of a Monthly High Dose of Vitamin D3 on Bariatric Surgery Patients
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