ClinicalTrials.gov
ClinicalTrials.gov Menu

Vitamin D Supplementation in Healthy Adolescents

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.
ClinicalTrials.gov Identifier: NCT01126671
Recruitment Status : Completed
First Posted : May 20, 2010
Results First Posted : April 19, 2013
Last Update Posted : June 4, 2018
Sponsor:
Information provided by (Responsible Party):
Sarah Pitts, Boston Children’s Hospital

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

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.

Fifty-six patients were enrolled, and two patients were randomized to a treatment group but did not complete a baseline visit and therefore are not included in the analysis.


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   26   30 
COMPLETED   24   29 
NOT COMPLETED   2   1 



  Baseline Characteristics

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 [1] 
[Units: Participants]
Count of Participants
     
<=18 years      24  96.0%      26  89.7%      50  92.6% 
Between 18 and 65 years      1   4.0%      3  10.3%      4   7.4% 
>=65 years      0   0.0%      0   0.0%      0   0.0% 
[1] 2 subjects were randomized to a treatment group but did not complete the baseline assessment.
Age 
[Units: Years]
Mean (Standard Deviation)
 16.1  (2.2)   16.1  (2.2)   16.1  (2.2) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
     
Female      21  84.0%      18  62.1%      39  72.2% 
Male      4  16.0%      11  37.9%      15  27.8% 
Region of Enrollment 
[Units: Participants]
     
United States   25   29   54 


  Outcome Measures

1.  Primary:   Baseline 25 Hydroxy Vitamin D (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 ]

4.  Secondary:   Assessment of Bone Markers at Follow-up   [ Time Frame: 12 weeks ]


  Serious Adverse Events


  Other Adverse Events


  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
No text entered.


  More Information

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:

Responsible Party: Sarah Pitts, Boston Children’s Hospital
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: June 4, 2018