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Effect of Vitamin D on Metabolic Profile in Overweight or Obese Women

This study has been completed.
Sponsor:
Collaborator:
Shahid Beheshti Medical University
Information provided by (Responsible Party):
Tehran University of Medical Sciences
ClinicalTrials.gov Identifier:
NCT01344161
First received: April 18, 2011
Last updated: October 9, 2012
Last verified: October 2012
Results First Received: July 25, 2011  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Investigator);   Primary Purpose: Prevention
Conditions: Overweight
Obesity
Interventions: Dietary Supplement: Placebo
Dietary Supplement: vitamin D

  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
In November 2009 we distributed advertisements in campus of Tehran University of Medical Sciences (TUMS) and invited all female students and employee to participate in our study.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Lactose In placebo group women used a pill of 25 microgram lactose every day for 12-weeks.
Vitamin D In vitamin D group women used a pill of 25 microgram cholecalciferol every day for 12-weeks.

Participant Flow:   Overall Study
    Lactose     Vitamin D  
STARTED     43     42  
COMPLETED     38     39  
NOT COMPLETED     5     3  
Lost to Follow-up                 4                 1  
Pregnancy                 0                 1  
Protocol Violation                 1                 1  



  Baseline Characteristics
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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
Lactose In placebo group women used a pill of 25 microgram lactose every day for 12-weeks.
Vitamin D In vitamin D group women used a pill of 25 microgram cholecalciferol every day for 12-weeks.
Total Total of all reporting groups

Baseline Measures
    Lactose     Vitamin D     Total  
Number of Participants  
[units: participants]
  38     39     77  
Age  
[units: participants]
     
<=18 years     0     0     0  
Between 18 and 65 years     38     39     77  
>=65 years     0     0     0  
Age  
[units: years]
Mean ± Standard Deviation
  38.9  ± 7     37  ± 8     38  ± 8  
Gender  
[units: participants]
     
Female     38     39     77  
Male     0     0     0  
Region of Enrollment  
[units: participants]
     
Iran, Islamic Republic of     38     39     77  



  Outcome Measures
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1.  Primary:   Change in Body Fat Mass   [ Time Frame: 3 months minus baseline ]

2.  Primary:   Change in Glucose Concentrations   [ Time Frame: 3 months minus baseline ]

3.  Primary:   Change in Post Load Glucose Concentrations   [ Time Frame: 3 months minus baseline ]

4.  Primary:   Change in Insulin Concentrations   [ Time Frame: 3 months minus baseline ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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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
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  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Dr.Farzad Shidfar
Organization: Tehran University of Medical Sciences
phone: 09123082922
e-mail: f-shidfar@tums.ac.ir


No publications provided by Tehran University of Medical Sciences

Publications automatically indexed to this study:

Responsible Party: Tehran University of Medical Sciences
ClinicalTrials.gov Identifier: NCT01344161     History of Changes
Other Study ID Numbers: IRCT138809092709N2
Study First Received: April 18, 2011
Results First Received: July 25, 2011
Last Updated: October 9, 2012
Health Authority: Iran: Ethics Committee