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Vitamin D Supplementation to Obese Chinese Males

NCT ID: NCT01781169

Last Updated: 2013-10-30

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

43 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-04-30

Study Completion Date

2012-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Obesity Insulin Resistance

Keywords

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Vitamin D, Oral supplementation, Obese males

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

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Obese group

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

Group Type EXPERIMENTAL

Oral supplementation of vitamin D

Intervention Type 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.

Normal-weight group

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

Group Type EXPERIMENTAL

Oral supplementation of vitamin D

Intervention Type 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.

Interventions

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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.

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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

* diagnosed as having any organic diseases were excluded
Minimum Eligible Age

23 Years

Maximum Eligible Age

66 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

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Danone Institute China Diet Nutrition Research and Communication

UNKNOWN

Sponsor Role collaborator

Shenzhen Center for Chronic Disease Control

OTHER

Sponsor Role lead

Responsible Party

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Zhou Ji-Chang

Vice Dean of Molecular Biology Lab

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Ji-Chang Zhou, Ph.D

Role: PRINCIPAL_INVESTIGATOR

Shenzhen Center for Chronic Disease Control

Locations

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Shenzhen Center for Chronic Disease Control

Shenzhen, Guangdong, China

Site Status

Countries

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China

References

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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.

Reference Type BACKGROUND
PMID: 21177785 (View on PubMed)

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.

Reference Type RESULT
PMID: 9519960 (View on PubMed)

Holick MF. Vitamin D deficiency. N Engl J Med. 2007 Jul 19;357(3):266-81. doi: 10.1056/NEJMra070553. No abstract available.

Reference Type RESULT
PMID: 17634462 (View on PubMed)

Other Identifiers

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VD50kIU2011

Identifier Type: -

Identifier Source: org_study_id