Effect of a Monthly High Dose of Vitamin D3 on Bariatric Surgery Patients
NCT ID: NCT02477956
Last Updated: 2015-06-23
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
31 participants
INTERVENTIONAL
2012-11-30
2013-12-31
Brief Summary
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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.
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Detailed Description
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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).
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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vitamin D3
subjects taking the standard vitamin D protocol with added monthly high dose cholecalciferol of 100,000 IU cholecalciferol
vitamin D3 (Replesta)
vitamin D group receive 2 replesta tablets (100,000 IU/month) of cholecalciferol.
Control
group of subjects taking the standard vitamin D
vitamin D
Interventions
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vitamin D3 (Replesta)
vitamin D group receive 2 replesta tablets (100,000 IU/month) of cholecalciferol.
vitamin D
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* elevated serum vitamin D and calcium
* pregnant and lactating women
18 Years
60 Years
ALL
No
Sponsors
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Texas Tech University
OTHER
Responsible Party
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Principal Investigators
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David Syn, MD
Role: PRINCIPAL_INVESTIGATOR
Texas Tech University Health Sciences Center
Mallory Boylan, PhD
Role: STUDY_DIRECTOR
Texas Tech University
Hadil Subih, PhD
Role: STUDY_CHAIR
Texas Tech University
Shannon Owens, PhD
Role: STUDY_CHAIR
Texas Tech University
Locations
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Texas Tech University
Lubbock, Texas, United States
Countries
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Other Identifiers
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Highly dose of vitamin D3
Identifier Type: -
Identifier Source: org_study_id
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