Vitamin D Supplementation to Obese Chinese Males

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01781169
Recruitment Status : Completed
First Posted : January 31, 2013
Results First Posted : September 30, 2013
Last Update Posted : October 30, 2013
Danone Institute China Diet Nutrition Research and Communication
Information provided by (Responsible Party):
Zhou Ji-Chang, Shenzhen Center for Chronic Disease Control

Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Health Services Research
Conditions: Obesity
Insulin Resistance
Intervention: Dietary Supplement: Oral supplementation of vitamin D

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Subjects were recruited at a medical clinic (Health Service Center of Shuiku Community, Shenzhen, China) in May, 2011.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
After enrollment, baseline information of the volunteers including vitamin D nutritional status, health records, etc. were evaluated. Including and excluding criteria were used to select the subjects who were suitable for the intervention trial.

Reporting Groups
Obese Group Oral supplementation of vitamin D (cholecalciferol), 50000 IU/wk for 8 weeks.
Normal-weight Group Oral supplementation of vitamin D (cholecalciferol), 50000 IU/wk for 8 weeks.

Participant Flow:   Overall Study
    Obese Group   Normal-weight Group
STARTED   22   21 
COMPLETED   21   21 

  Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
Normal-weight Group No text entered.
Obese Group No text entered.
Total Total of all reporting groups

Baseline Measures
   Normal-weight Group   Obese Group   Total 
Overall Participants Analyzed 
[Units: Participants]
 21   21   42 
[Units: Participants]
<=18 years   0   0   0 
Between 18 and 65 years   21   20   41 
>=65 years   0   1   1 
[Units: Years]
Mean (Standard Deviation)
 34.4  (8)   44.7  (8.8)   39.5  (9.8) 
[Units: Participants]
Female   0   0   0 
Male   21   21   42 
Region of Enrollment 
[Units: Participants]
China   21   21   42 

  Outcome Measures

1.  Primary:   Plasma 25-hydroxy Vitamin D (25(OH)D) Level (Nmol/L)   [ Time Frame: Endpoint and baseline of the 8 weeks' trial ]

  Serious Adverse Events

  Other Adverse Events

  Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
The numbers of participants in both the obese group and normal-weight group were small.

  More Information

Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.

Results Point of Contact:  
Name/Title: Dr. Ji-Chang Zhou
Organization: Shenzhen Center for Chronic Disease Control
phone: 86-755-25503842

Publications of Results:
Other Publications:

Responsible Party: Zhou Ji-Chang, Shenzhen Center for Chronic Disease Control Identifier: NCT01781169     History of Changes
Other Study ID Numbers: VD50kIU2011
First Submitted: January 25, 2013
First Posted: January 31, 2013
Results First Submitted: May 29, 2013
Results First Posted: September 30, 2013
Last Update Posted: October 30, 2013