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Effect of Calcium + Vitamin D Supplementation on Weight Management in Very-low Calcium Consumers

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Donglian Cai, Changhai Hospital
ClinicalTrials.gov Identifier:
NCT01447433
First received: October 4, 2011
Last updated: July 26, 2012
Last verified: July 2012
History of Changes
Results First Received: January 3, 2012  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Conditions: Obesity
Overweight
Interventions: Drug: Calcium Carbonate
Behavioral: Energy restriction

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Participant were recruited through informational flyers and advertisements posted on campus of colleges and vocational schools in Pudong and Yangpu Districts in Shanghai, China. From April 20th to September 20th, 2011, a total of 129 out of 187 volunteers who answered our recruitment advertisements were invited for a pre-screening interview.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
The pre-screening FFQ excluded 34 volunteers for habitual calcium intake＞600mg/day. During screening, 16 were excluded for BMI＜24kg/m2, 3 reported for using calcium supplements, 14 were on a diet, 2 refused to take calcium supplements, 1 refused to being taken blood samples, and 6 failed to sign the informed consents for personal reasons.

Reporting Groups
  Description
Calcium+D Calcium supplements provide 600mg of calcium and 125IU vitamin D per day. A balanced diet contains 500kcal of caloric deficit based on daily energy expenditure.
Control A balanced diet contains 500kcal of caloric deficit based on daily energy expenditure.

Participant Flow:   Overall Study
    Calcium+D     Control  
STARTED     26     27  
COMPLETED     22     21  
NOT COMPLETED     4     6  
Lost to Follow-up                 0                 2  
Withdrawal by Subject                 3                 3  
Protocol Violation                 1                 1  



  Baseline Characteristics
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Reporting Groups
  Description
Calcium+D Calcium supplements provide 600mg of calcium and 125IU vitamin D per day. A balanced diet contains 500kcal of caloric deficit based on daily energy expenditure.
Control A balanced diet contains 500kcal of caloric deficit based on daily energy expenditure.
Total Total of all reporting groups

Baseline Measures
    Calcium+D     Control     Total  
Number of Participants  
[units: participants]
 		  26     27     53  
Age  
[units: participants]
 		     
<=18 years     0     0     0  
Between 18 and 65 years     26     27     53  
>=65 years     0     0     0  
Age  
[units: years]
Mean ± Standard Deviation 		  20.3  ± 1.4     20.4  ± 0.8     20.3  ± 1.1  
Gender  
[units: participants]
 		     
Female     23     23     46  
Male     3     4     7  
Region of Enrollment  
[units: participants]
 		     
China     26     27     53  



  Outcome Measures
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1.  Primary:   Change in Body Weight   [ Time Frame: Baseline and 12 weeks ]
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2.  Secondary:   Change in Body Fat Mass，Body Lean Mass and Visceral Fat Mass   [ Time Frame: Baseline and 12 weeks ]
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3.  Secondary:   Change in Fat Percentage   [ Time Frame: Baseline and 12 weeks ]
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4.  Secondary:   Change in Visceral Fat Area   [ Time Frame: Baseline and 12 weeks ]
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5.  Secondary:   Change in Waist, Abdominal and Hip Circumference   [ Time Frame: Baseline and 12 weeks ]
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6.  Secondary:   Change in Blood Pressure   [ Time Frame: Baseline and 12 weeks ]
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7.  Secondary:   Change in Lipid-lipoprotein Profile   [ Time Frame: Baseline and 12 weeks ]
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8.  Secondary:   Change in Fasting Plasma Glucose   [ Time Frame: Baseline and 12 weeks ]
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9.  Secondary:   Change in Fasting Plasma Insulin   [ Time Frame: Baseline and 12 weeks ]
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10.  Secondary:   Change in Energy Intakes   [ Time Frame: Baseline and 12 weeks ]
  Show Outcome Measure 10


  Serious Adverse Events
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  Other Adverse Events
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  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


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 study sample was mostly women.  


Results Point of Contact:  
Name/Title: Prof. Donglian Cai
Organization: Changhai Hospital
phone: 86 21 81873168
e-mail: nutrition1226@126.com


No publications provided by Changhai Hospital

Publications automatically indexed to this study:


Responsible Party: Donglian Cai, Changhai Hospital
ClinicalTrials.gov Identifier: NCT01447433     History of Changes
Other Study ID Numbers: 201011Z-02
Study First Received: October 4, 2011
Results First Received: January 3, 2012
Last Updated: July 26, 2012
Health Authority: China: Science and Technology Commission of Shanghai Municipality