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Vitamin D Supplementation to Obese Chinese Males

Primary Purpose

Obesity, Insulin Resistance

Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Oral supplementation of vitamin D
Sponsored by
Shenzhen Center for Chronic Disease Control
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Obesity focused on measuring Vitamin D,, Oral supplementation,, Obese males

Eligibility Criteria

23 Years - 66 Years (Adult, Older Adult)MaleAccepts Healthy Volunteers

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

Sites / Locations

  • Shenzhen Center for Chronic Disease Control

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Obese group

Normal-weight group

Arm Description

Oral supplementation of vitamin D (cholecalciferol), 50000 IU/wk for 8 weeks.

Oral supplementation of vitamin D (cholecalciferol), 50000 IU/wk for 8 weeks.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
January 25, 2013
Last Updated
September 27, 2013
Sponsor
Shenzhen Center for Chronic Disease Control
Collaborators
Danone Institute China Diet Nutrition Research and Communication
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1. Study Identification

Unique Protocol Identification Number
NCT01781169
Brief Title
Vitamin D Supplementation to Obese Chinese Males
Official Title
Health Effect of Oral Vitamin D Supplementation on Obese Chinese Males
Study Type
Interventional

2. Study Status

Record Verification Date
September 2013
Overall Recruitment Status
Completed
Study Start Date
April 2011 (undefined)
Primary Completion Date
December 2011 (Actual)
Study Completion Date
December 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Shenzhen Center for Chronic Disease Control
Collaborators
Danone Institute China Diet Nutrition Research and Communication

4. Oversight

Data Monitoring Committee
Yes

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity, Insulin Resistance
Keywords
Vitamin D,, Oral supplementation,, Obese males

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
43 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Obese group
Arm Type
Experimental
Arm Description
Oral supplementation of vitamin D (cholecalciferol), 50000 IU/wk for 8 weeks.
Arm Title
Normal-weight group
Arm Type
Experimental
Arm Description
Oral supplementation of vitamin D (cholecalciferol), 50000 IU/wk for 8 weeks.
Intervention Type
Dietary Supplement
Intervention Name(s)
Oral supplementation of vitamin D
Intervention Description
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 Outcome Measure Information:
Title
Plasma 25-hydroxy Vitamin D (25(OH)D) Level (Nmol/L)
Time Frame
Endpoint and baseline of the 8 weeks' trial

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
23 Years
Maximum Age & Unit of Time
66 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ji-Chang Zhou, Ph.D
Organizational Affiliation
Shenzhen Center for Chronic Disease Control
Official's Role
Principal Investigator
Facility Information:
Facility Name
Shenzhen Center for Chronic Disease Control
City
Shenzhen
State/Province
Guangdong
ZIP/Postal Code
518020
Country
China

12. IPD Sharing Statement

Citations:
PubMed Identifier
21177785
Citation
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.
Results Reference
background
PubMed Identifier
9519960
Citation
Malabanan A, Veronikis IE, Holick MF. Redefining vitamin D insufficiency. Lancet. 1998 Mar 14;351(9105):805-6. doi: 10.1016/s0140-6736(05)78933-9. No abstract available.
Results Reference
result
PubMed Identifier
17634462
Citation
Holick MF. Vitamin D deficiency. N Engl J Med. 2007 Jul 19;357(3):266-81. doi: 10.1056/NEJMra070553. No abstract available.
Results Reference
result

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Vitamin D Supplementation to Obese Chinese Males

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