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Vitamin D Supplementation in Healthy Adolescents

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01126671
First Posted: May 20, 2010
Last Update Posted: April 19, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Sarah Pitts, Children's Hospital Boston
Results First Submitted: March 8, 2013  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, 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 
Overall Participants Analyzed 
[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
  Show All Outcome Measures

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.  

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


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


Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Sarah Pitts, Children's Hospital Boston
ClinicalTrials.gov Identifier: NCT01126671     History of Changes
Other Study ID Numbers: 08-06-0271
First Submitted: May 18, 2010
First Posted: May 20, 2010
Results First Submitted: March 8, 2013
Results First Posted: April 19, 2013
Last Update Posted: April 19, 2013