Vitamin D Supplementation to Obese Chinese Males

This study has been completed.
Sponsor:
Collaborator:
Danone Institute China Diet Nutrition Research and Communication
Information provided by (Responsible Party):
Zhou Ji-Chang, Shenzhen Center for Chronic Disease Control
ClinicalTrials.gov Identifier:
NCT01781169
First received: January 25, 2013
Last updated: September 27, 2013
Last verified: September 2013

January 25, 2013
September 27, 2013
April 2011
December 2011   (final data collection date for primary outcome measure)
Plasma 25-hydroxy Vitamin D (25(OH)D) Level (Nmol/L) [ Time Frame: Endpoint and baseline of the 8 weeks' trial ] [ Designated as safety issue: Yes ]
Changes from baseline in insulin Resistance and serum parathyroid hormone concentration [ Time Frame: Two months ] [ Designated as safety issue: Yes ]
Insulin Resistance was evaluated by the homeostasis model assessment of insulin resistance index. The parathyroid hormone concentration was measured with ELISA kit.
Complete list of historical versions of study NCT01781169 on ClinicalTrials.gov Archive Site
Not Provided
Change from baseline in nutritional status of vitamin D [ Time Frame: Two months ] [ Designated as safety issue: Yes ]
Serum 25(OH)D concentration measured by ELISA kit of IDS Ltd.
Not Provided
Not Provided
 
Vitamin D Supplementation to Obese Chinese Males
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.

Not Provided
Interventional
Not Provided
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Health Services Research
  • Obesity
  • Insulin Resistance
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: Obese group
    Oral supplementation of vitamin D (cholecalciferol), 50000 IU/wk for 8 weeks.
    Intervention: Dietary Supplement: Oral supplementation of vitamin D
  • Experimental: Normal-weight group
    Oral supplementation of vitamin D (cholecalciferol), 50000 IU/wk for 8 weeks.
    Intervention: Dietary Supplement: Oral supplementation of vitamin D

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
43
December 2012
December 2011   (final data collection date for primary outcome measure)

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
Male
23 Years to 66 Years
Yes
Contact information is only displayed when the study is recruiting subjects
China
 
NCT01781169
VD50kIU2011
Yes
Zhou Ji-Chang, Shenzhen Center for Chronic Disease Control
Shenzhen Center for Chronic Disease Control
Danone Institute China Diet Nutrition Research and Communication
Principal Investigator: Ji-Chang Zhou, Ph.D Shenzhen Center for Chronic Disease Control
Shenzhen Center for Chronic Disease Control
September 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP