Vitamin D Supplementation to Obese Chinese Males

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ClinicalTrials.gov Identifier: NCT01781169

Recruitment Status : Completed

First Posted : January 31, 2013

Results First Posted : September 30, 2013

Last Update Posted : October 30, 2013

Sponsor:

Collaborator:

Danone Institute China Diet Nutrition Research and Communication

Information provided by (Responsible Party):

Zhou Ji-Chang, Shenzhen Center for Chronic Disease Control

Study Description

Brief Summary:

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.

Condition or disease	Intervention/treatment	Phase
Obesity Insulin Resistance	Dietary Supplement: Oral supplementation of vitamin D	Not Applicable

Study Design

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Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	43 participants
Allocation:	Non-Randomized
Intervention Model:	Parallel Assignment
Masking:	None (Open Label)
Primary Purpose:	Health Services Research
Official Title:	Health Effect of Oral Vitamin D Supplementation on Obese Chinese Males
Study Start Date :	April 2011
Actual Primary Completion Date :	December 2011
Actual Study Completion Date :	December 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Vitamin D

Drug Information available for: Vitamin D

U.S. FDA Resources

Arms and Interventions

Arm	Intervention/treatment
Experimental: Obese group Oral supplementation of vitamin D (cholecalciferol), 50000 IU/wk for 8 weeks.	Dietary Supplement: Oral supplementation of vitamin D 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.	Dietary Supplement: Oral supplementation of vitamin D 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.

Outcome Measures

Primary Outcome Measures :

Plasma 25-hydroxy Vitamin D (25(OH)D) Level (Nmol/L) [ Time Frame: Endpoint and baseline of the 8 weeks' trial ]

Eligibility Criteria

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Ages Eligible for Study:	23 Years to 66 Years (Adult, Older Adult)
Sexes Eligible for Study:	Male
Accepts Healthy Volunteers:	Yes

Criteria

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

Contacts and Locations

Information from the National Library of Medicine

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): NCT01781169

Locations

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China, Guangdong
Shenzhen Center for Chronic Disease Control
Shenzhen, Guangdong, China, 518020

Sponsors and Collaborators

Shenzhen Center for Chronic Disease Control

Danone Institute China Diet Nutrition Research and Communication

Investigators

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Principal Investigator:	Ji-Chang Zhou, Ph.D	Shenzhen Center for Chronic Disease Control

More Information

Publications of Results:

Malabanan A, Veronikis IE, Holick MF. Redefining vitamin D insufficiency. Lancet. 1998 Mar 14;351(9105):805-6.

Holick MF. Vitamin D deficiency. N Engl J Med. 2007 Jul 19;357(3):266-81. Review.

Other Publications:

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.

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Responsible Party:	Zhou Ji-Chang, Vice Dean of Molecular Biology Lab, Shenzhen Center for Chronic Disease Control
ClinicalTrials.gov Identifier:	NCT01781169
Other Study ID Numbers:	VD50kIU2011
First Posted:	January 31, 2013 Key Record Dates
Results First Posted:	September 30, 2013
Last Update Posted:	October 30, 2013
Last Verified:	September 2013

Keywords provided by Zhou Ji-Chang, Shenzhen Center for Chronic Disease Control:


Vitamin D, Oral supplementation, Obese males

Additional relevant MeSH terms:

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Insulin Resistance Hyperinsulinism Glucose Metabolism Disorders Metabolic Diseases Vitamin D	Vitamins Micronutrients Physiological Effects of Drugs Bone Density Conservation Agents

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