Vitamin D Supplementation in Healthy Adolescents

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Sarah Pitts, Children's Hospital Boston
ClinicalTrials.gov Identifier:
NCT01126671
First received: May 18, 2010
Last updated: March 8, 2013
Last verified: March 2013
Results First Received: March 8, 2013  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Vitamin D Supplementation
Intervention: Drug: Supplemental 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
Subjects were recruited from the Boston Children’s Hospital (BCH) Adolescent Medicine Outpatient Program and from the community via flyers, internet postings, and newspaper advertisements. Enrollment began September 1, 2008 and ended March 18, 2011.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Healthy adolescents, ages 11-19 years, were eligible if clinically healthy, likely to comply with treatment, and not vitamin D deficient.

Reporting Groups
  Description
Low Dose Vitamin D Subjects in this arm of the study took 200 IU vit D3 daily.
High Dose Vitamin D Subjects in this arm of the study took 1000 IU vit D3 daily.

Participant Flow:   Overall Study
    Low Dose Vitamin D     High Dose Vitamin D  
STARTED     25     29  
COMPLETED     25     29  
NOT COMPLETED     0     0  



  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
Low Dose Vitamin D Subjects in this arm of the study took 200 IU vit D3 daily.
High Dose Vitamin D Subjects in this arm of the study took 1000 IU vit D3 daily.
Total Total of all reporting groups

Baseline Measures
    Low Dose Vitamin D     High Dose Vitamin D     Total  
Number of Participants  
[units: participants]
  25     29     54  
Age  
[units: participants]
     
<=18 years     24     26     50  
Between 18 and 65 years     1     3     4  
>=65 years     0     0     0  
Age  
[units: years]
Mean ± Standard Deviation
  16.1  ± 2.2     16.1  ± 2.2     16.1  ± 2.2  
Gender  
[units: participants]
     
Female     21     18     39  
Male     4     11     15  
Region of Enrollment  
[units: participants]
     
United States     25     29     54  



  Outcome Measures
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1.  Primary:   Baseline 25OHD Levels   [ Time Frame: Baseline ]

2.  Primary:   Follow-up 25OHD Levels   [ Time Frame: 12 weeks ]

3.  Secondary:   Baseline Assessment of Bone Markers   [ Time Frame: Baseline ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No

4.  Secondary:   Assessment of Bone Markers at Follow-up   [ Time Frame: 12 weeks ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No


  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. Sarah Pitts
Organization: Boston Children's Hospital
phone: 617-355-3732
e-mail: sarah.pitts@childrens.harvard.edu


No publications provided by Children's Hospital Boston

Publications automatically indexed to this study:

Responsible Party: Sarah Pitts, Children's Hospital Boston
ClinicalTrials.gov Identifier: NCT01126671     History of Changes
Other Study ID Numbers: 08-06-0271
Study First Received: May 18, 2010
Results First Received: March 8, 2013
Last Updated: March 8, 2013
Health Authority: United States: Institutional Review Board