Vitamin D Supplementation to Obese Chinese Males

Obesity Clinical Trial

Official title:

Health Effect of Oral Vitamin D Supplementation on Obese Chinese Males

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01781169
• Other study ID #: VD50kIU2011
• Status: Completed
• Phase: N/A
• First received: January 25, 2013
• Last updated: September 27, 2013
• Start date: April 2011
• Est. completion date: December 2012

Study information

• Verified date: September 2013
• Source: Shenzhen Center for Chronic Disease Control
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Chinese Center for Disease Control and Prevention
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 43
• Est. completion date: December 2012
• Est. primary completion date: December 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 23 Years to 66 Years

Eligibility

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 Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Health Services Research

Related Conditions & MeSH terms

• Insulin Resistance
• Obesity

Intervention

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.

Locations

Country	Name	City	State
China	Shenzhen Center for Chronic Disease Control	Shenzhen	Guangdong

Sponsors (2)

Lead Sponsor	Collaborator
Shenzhen Center for Chronic Disease Control	Danone Institute China Diet Nutrition Research and Communication

Country where clinical trial is conducted

China, 

References & Publications (3)

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. — View Citation

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

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

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Plasma 25-hydroxy Vitamin D (25(OH)D) Level (Nmol/L)		Endpoint and baseline of the 8 weeks' trial	Yes