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Completed

NCT Number: NCT01781169

Vitamin D Supplementation to 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.

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Key information

Conditions

Obesity Body Weight Glucose Metabolism Disorders Hyperinsulinism Insulin Resistance Metabolic Diseases Nutrition Disorders Nutritional and Metabolic Diseases Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

23 year–66 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Shenzhen Center for Chronic Disease Control

Shenzhen, Guangdong, 518020, China

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Oral supplementation of vitamin D

Dietary Supplement

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.

Primary outcomes

  1. Plasma 25-hydroxy Vitamin D (25(OH)D) Level (Nmol/L)

    Time frame: Endpoint and baseline of the 8 weeks' trial

Sponsors and collaborators

Lead sponsor

Shenzhen Center for Chronic Disease Control

Other

Collaborators

  • Danone Institute China Diet Nutrition Research and Communication

Registry information

Official study title

Health Effect of Oral Vitamin D Supplementation on Obese Chinese Males

Important dates

Study start
2011
Primary completion
2011
Study completion
2012
First posted
Jan 31, 2013
Registry last updated
Oct 30, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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