Vitamin D Supplementation to Obese Chinese Males

This study has been completed.
Sponsor:
Collaborator:
Danone Institute China Diet Nutrition Research and Communication
Information provided by (Responsible Party):
Zhou Ji-Chang, Shenzhen Center for Chronic Disease Control
ClinicalTrials.gov Identifier:
NCT01781169
First received: January 25, 2013
Last updated: September 27, 2013
Last verified: September 2013
Results First Received: May 29, 2013  
Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Health Services Research
Conditions: Obesity
Insulin Resistance
Intervention: Dietary Supplement: Oral supplementation of vitamin D

  Participant Flow
  Hide 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
  Description
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  
NOT COMPLETED     1     0  



  Baseline Characteristics
  Hide 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
  Description
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  
Number of Participants  
[units: participants]
  21     21     42  
Age  
[units: participants]
     
<=18 years     0     0     0  
Between 18 and 65 years     21     20     41  
>=65 years     0     1     1  
Age  
[units: years]
Mean ± Standard Deviation
  34.4  ± 8     44.7  ± 8.8     39.5  ± 9.8  
Gender  
[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
  Hide 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
  Hide 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
e-mail: jichangzhou@gmail.com


Publications of Results:
Other Publications:

Responsible Party: Zhou Ji-Chang, Shenzhen Center for Chronic Disease Control
ClinicalTrials.gov Identifier: NCT01781169     History of Changes
Other Study ID Numbers: VD50kIU2011
Study First Received: January 25, 2013
Results First Received: May 29, 2013
Last Updated: September 27, 2013
Health Authority: China: Chinese Center for Disease Control and Prevention