Effect of Vitamin D3 Supplementation on Insulin Resistance and Cardiovascular Risk Factors in Obese Adolescents

This study has been completed.
Sponsor:
Collaborators:
Thrasher Research Fund
Information provided by:
Mayo Clinic
ClinicalTrials.gov Identifier:
NCT00858247
First received: March 5, 2009
Last updated: May 13, 2014
Last verified: May 2014
Results First Received: December 16, 2013  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor);   Primary Purpose: Prevention
Condition: Obesity
Intervention: Dietary Supplement: Vitamin D3

  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
Participants were enrolled at the Mayo Clinic in Rochester, Minnesota.

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
Vitamin D3-low Dose

Vitamin D3 400 IU capsule, one capsule daily

Vitamin D3: One arm would receive vitamin D3 at a dose of 400 IU by mouth once daily for 12 weeks and the other arm would receive vitamin D3 as a single oral daily dose of 2000 IU for 12 weeks.

Vitamin D3-high Dose

Vitamin D3 2000 IU capsule, one capsule daily

Vitamin D3: One arm would receive vitamin D3 at a dose of 400 IU by mouth once daily for 12 weeks and the other arm would receive vitamin D3 as a single oral daily dose of 2000 IU for 12 weeks.


Participant Flow for 2 periods

Period 1:   Baseline Assessment
    Vitamin D3-low Dose     Vitamin D3-high Dose  
STARTED     25     26  
COMPLETED     23     24  
NOT COMPLETED     2     2  
Withdrawal by Subject                 1                 1  
Poor IV access                 1                 0  
Protocol Violation                 0                 1  

Period 2:   Week 12 Follow-up
    Vitamin D3-low Dose     Vitamin D3-high Dose  
STARTED     23     24  
COMPLETED     23     23  
NOT COMPLETED     0     1  
Withdrawal by Subject                 0                 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.
47 Subjects started the study, but one subject in the Vitamin D3-high dose arm only completed one visit. The baseline characteristics are reported on the 47 subjects who started the study.

Reporting Groups
  Description
Vitamin D3-low Dose Vitamin D3 400 IU capsule, one capsule daily
Vitamin D3-high Dose Vitamin D3 2000 IU capsule, one capsule daily
Total Total of all reporting groups

Baseline Measures
    Vitamin D3-low Dose     Vitamin D3-high Dose     Total  
Number of Participants  
[units: participants]
  23     24     47  
Age  
[units: years]
Median ( Inter-Quartile Range )
  14.5  
  ( 13.5 to 16.6 )  
  14.7  
  ( 13.5 to 16.0 )  
  14.5  
  ( 13.5 to 16.4 )  
Gender  
[units: participants]
     
Female     9     18     27  
Male     14     6     20  
Region of Enrollment  
[units: participants]
     
United States     23     24     47  



  Outcome Measures
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1.  Primary:   Change in Insulin Resistance After 12 Weeks of Vitamin D3 Supplementation   [ Time Frame: Baseline, 12 weeks ]

2.  Secondary:   Change in Total Cholesterol After 12 Weeks of Vitamin D Supplementation   [ Time Frame: baseline, 12 weeks ]

3.  Secondary:   Change in Low Density Lipoprotein (LDL) Cholesterol After 12 Weeks of Vitamin D Supplementation   [ Time Frame: baseline, 12 weeks ]

4.  Secondary:   Change in High Density Lipoprotein (HDL) Cholesterol After 12 Weeks of Vitamin D Supplementation   [ Time Frame: baseline, 12 weeks ]

5.  Secondary:   Change in Triglycerides After 12 Weeks of Vitamin D Supplementation   [ Time Frame: baseline, 12 weeks ]

6.  Secondary:   Change in High-Sensitivity C-Reactive Protein After 12 Weeks of Vitamin D Supplementation   [ Time Frame: baseline, 12 weeks ]


  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
No text entered.


  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: Seema Kumar, MD
Organization: Mayo Clinic
phone: 507-284-3300
e-mail: kumar.seema@mayo.edu


No publications provided


Responsible Party: Seema Kumar, M.D., Mayo Clinic
ClinicalTrials.gov Identifier: NCT00858247     History of Changes
Other Study ID Numbers: 08-008743, UL1RR024150
Study First Received: March 5, 2009
Results First Received: December 16, 2013
Last Updated: May 13, 2014
Health Authority: United States: Institutional Review Board