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

History of Changes

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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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 ]

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2. Primary:

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

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3. Secondary:

Baseline Assessment of Bone Markers [ Time Frame: Baseline ]

Results not yet posted. Anticipated Posting Date: No text entered. Safety Issue: No

4. Secondary:

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

Results not yet posted. Anticipated Posting Date: No text entered. Safety Issue: No

Serious Adverse Events

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Other Adverse Events

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More Information

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Certain Agreements:

All Principal Investigators ARE employed by the organization sponsoring the study.

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.

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

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

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