Effect of a Monthly High Dose of Vitamin D3 on Bariatric Surgery Patients
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|ClinicalTrials.gov Identifier: NCT02477956|
Recruitment Status : Completed
First Posted : June 23, 2015
Last Update Posted : June 23, 2015
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.
|Condition or disease||Intervention/treatment||Phase|
|Morbid Obesity Vitamin D Deficiency||Dietary Supplement: vitamin D3 (Replesta) Dietary Supplement: vitamin D||Phase 1|
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 (Clinical Trial)|
|Actual Enrollment :||31 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||Impact of Monthly High Dose Oral Cholecalciferol on Serum 25 Hydroxy Vitamin D Levels in Bariatric Surgery Subjects|
|Study Start Date :||November 2012|
|Actual Primary Completion Date :||November 2013|
|Actual Study Completion Date :||December 2013|
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 Name: Replesta
Active Comparator: Control
group of subjects taking the standard vitamin D
Dietary Supplement: vitamin D
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02477956
|United States, Texas|
|Texas Tech University|
|Lubbock, Texas, United States, 79405|
|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|