Vitamin D Supplementation to Obese Chinese Males
September 27, 2013 updated by: Zhou Ji-Chang, Shenzhen Center for Chronic Disease Control
Health Effect of Oral Vitamin D Supplementation on Obese Chinese Males
Hypothesis: Oral Supplementation of Vitamin D can Reduce Hypersecretion of Parathyroid Hormone and Insulin Resistance in Obese Chinese Males.
Protocol: Weekly oral supplementation of 50,000 IU vitamin D (cholecalciferol) or eight weeks to the obese males compared with the normal-weight males. Index measures were conducted at baseline and endpoint.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
43
Phase
- Not Applicable
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
-
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Guangdong
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Shenzhen, Guangdong, China, 518020
- Shenzhen Center for Chronic Disease Control
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-
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
23 years to 66 years (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
Male
Description
Inclusion Criteria:
- body mass index (BMI) ≥ 28kg/m2 or 18.5 ≤ BMI < 24 (kg/m2)
- non vegetarian Han Chinese and did not smoke, drink, nor take vitamin D supplements for > 2 y
- fasting serum glucose < 7.0 mmol/L
- serum glucose of 2 hr after 75 g oral glucose loading < 11.1 mmol/L
- normal functioning of liver and kidney evaluated by alkaline phosphatase, aspartate aminotransferase, creatinine, and uric acid
Exclusion Criteria:
- not match the above inclusion criteria
- diagnosed as having any organic diseases were excluded
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: Health Services Research
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Obese group
Oral supplementation of vitamin D (cholecalciferol), 50000 IU/wk for 8 weeks.
|
Weekly oral supplementation of 50,000 IU vitamin D (cholecalciferol) for eight weeks to the obese males compared with the normal-weight males.
The chemical form of vitamin D is cholecalciferol capsuled as fine powder.
|
|
Experimental: Normal-weight group
Oral supplementation of vitamin D (cholecalciferol), 50000 IU/wk for 8 weeks.
|
Weekly oral supplementation of 50,000 IU vitamin D (cholecalciferol) for eight weeks to the obese males compared with the normal-weight males.
The chemical form of vitamin D is cholecalciferol capsuled as fine powder.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Plasma 25-hydroxy Vitamin D (25(OH)D) Level (Nmol/L)
Time Frame: Endpoint and baseline of the 8 weeks' trial
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Endpoint and baseline of the 8 weeks' trial
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Ji-Chang Zhou, Ph.D, Shenzhen Center for Chronic Disease Control
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Holick MF. Vitamin D deficiency. N Engl J Med. 2007 Jul 19;357(3):266-81. doi: 10.1056/NEJMra070553. No abstract available.
- Heaney RP, Recker RR, Grote J, Horst RL, Armas LA. Vitamin D(3) is more potent than vitamin D(2) in humans. J Clin Endocrinol Metab. 2011 Mar;96(3):E447-52. doi: 10.1210/jc.2010-2230. Epub 2010 Dec 22.
- Malabanan A, Veronikis IE, Holick MF. Redefining vitamin D insufficiency. Lancet. 1998 Mar 14;351(9105):805-6. doi: 10.1016/s0140-6736(05)78933-9. No abstract available.
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
April 1, 2011
Primary Completion (Actual)
December 1, 2011
Study Completion (Actual)
December 1, 2012
Study Registration Dates
First Submitted
January 25, 2013
First Submitted That Met QC Criteria
January 29, 2013
First Posted (Estimate)
January 31, 2013
Study Record Updates
Last Update Posted (Estimate)
October 30, 2013
Last Update Submitted That Met QC Criteria
September 27, 2013
Last Verified
September 1, 2013
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- VD50kIU2011
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.