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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: January 29, 2013
Last verified: January 2013
History of Changes
  Purpose

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 for eight weeks to the obese males compared with the normal-weight males. Index measures were conducted at baseline and endpoint.


Condition Intervention
Obesity
Insulin Resistance
 Dietary Supplement: Oral supplementation of vitamin D

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Health Services Research
Official Title: Health Effect of Oral Vitamin D Supplementation on Obese Chinese Males

Resource links provided by NLM:

Drug Information available for: Vitamin D
U.S. FDA Resources

Further study details as provided by Shenzhen Center for Chronic Disease Control:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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.


Enrollment: 50
Study Start Date: June 2011
Study Completion Date: December 2012
Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Obese group
Oral supplementation of vitamin D.
 Dietary Supplement: Oral supplementation of vitamin D
Weekly oral supplementation of 50,000 IU vitamin D for eight weeks to the obese males compared with the normal-weight males.
Experimental: Normal-weight group
Oral supplementation of vitamin D.
 Dietary Supplement: Oral supplementation of vitamin D
Weekly oral supplementation of 50,000 IU vitamin D for eight weeks to the obese males compared with the normal-weight males.

Detailed Description:

After vitamin D supplementation, serum 25(OH)D level, hypersecretions of parathyroid hormone and insulin, and insulin resistance in the obese were significantly improved (P < 0.05), but the increase of their serum 25(OH)D was less than that of the normal-weight.

  Eligibility

Ages Eligible for Study:   23 Years to 66 Years
Genders 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01781169

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

Publications:

Responsible Party: Zhou Ji-Chang, Vice Dean of Molecular Biology Lab, Shenzhen Center for Chronic Disease Control
ClinicalTrials.gov Identifier: NCT01781169     History of Changes
Other Study ID Numbers: VD50kIU2011
Study First Received: January 25, 2013
Last Updated: January 29, 2013
Health Authority: China: Chinese Center for Disease Control and Prevention

Keywords provided by Shenzhen Center for Chronic Disease Control:
Vitamin D,
Oral supplementation,
Obese males

Additional relevant MeSH terms:
Insulin Resistance
Obesity
Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases
Overnutrition
Nutrition Disorders
Overweight
Body Weight
 Signs and Symptoms
Vitamin D
Ergocalciferols
Vitamins
Bone Density Conservation Agents
Physiological Effects of Drugs
Pharmacologic Actions
Micronutrients
Growth Substances

ClinicalTrials.gov processed this record on May 19, 2013