NCT01781169

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
43

participants targeted

Target at P25-P50 for not_applicable obesity

Timeline
Completed

Started Apr 2011

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2011

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2011

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2012

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

January 25, 2013

Completed
6 days until next milestone

First Posted

Study publicly available on registry

January 31, 2013

Completed
8 months until next milestone

Results Posted

Study results publicly available

September 30, 2013

Completed
Last Updated

October 30, 2013

Status Verified

September 1, 2013

Enrollment Period

8 months

First QC Date

January 25, 2013

Results QC Date

May 29, 2013

Last Update Submit

September 27, 2013

Conditions

ObesityInsulin Resistance

Keywords

Vitamin D,Oral supplementation,Obese males

Outcome Measures

Primary Outcomes (1)

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

    Endpoint and baseline of the 8 weeks' trial

Study Arms (2)

Obese group

EXPERIMENTAL

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

Dietary Supplement: Oral supplementation of vitamin D

Normal-weight group

EXPERIMENTAL

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

Dietary Supplement: Oral supplementation of vitamin D

Interventions

Oral supplementation of vitamin DDIETARY_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 groupObese group

Eligibility Criteria

Age23 Years - 66 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • diagnosed as having any organic diseases were excluded

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Shenzhen Center for Chronic Disease Control

Shenzhen, Guangdong, 518020, China

Location

Related Publications (3)

  • 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.

    PMID: 21177785BACKGROUND

  • 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.

    PMID: 9519960RESULT

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

    PMID: 17634462RESULT

MeSH Terms

Conditions

ObesityInsulin Resistance

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsHyperinsulinismGlucose Metabolism DisordersMetabolic Diseases

Limitations and Caveats

The numbers of participants in both the obese group and normal-weight group were small.

Results Point of Contact

Title
Dr. Ji-Chang Zhou
Organization
Shenzhen Center for Chronic Disease Control
jichangzhou@gmail.com
86-755-25503842

Study Officials

  • Ji-Chang Zhou, Ph.D

    Shenzhen Center for Chronic Disease Control

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Vice Dean of Molecular Biology Lab

Study Record Dates

First Submitted

January 25, 2013

First Posted

January 31, 2013

Study Start

April 1, 2011

Primary Completion

December 1, 2011

Study Completion

December 1, 2012

Last Updated

October 30, 2013

Results First Posted

September 30, 2013

Record last verified: 2013-09

Locations

CN(1)