Vitamin D Supplementation in Healthy Adolescents

May 1, 2018 updated by: Sarah Pitts, Boston Children's Hospital

Clinical Trial of Vitamin D Supplementation in Healthy Adolescents

This double blind, randomized controlled trial compares two supplemental doses of vitamin D in health adolescents.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Vitamin D deficiency is a common problem. Currently, data do not support a recommended vitamin D supplementation dose for health adolescents to maintain normal vitamin D levels. This double blind, randomized controlled 12 week trial compares the use of two supplemental doses of vitamin D in this population.

Study Type

Interventional

Enrollment (Actual)

56

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Massachusetts
      • Boston, Massachusetts, United States, 02115
        • Children's Hospital Boston

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

11 years to 18 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 11-18 years old
  • healthy

Exclusion Criteria:

  • chronic disease
  • use of medication known to effect bone or vitamin D metabolism
  • abnormal vitamin D or calcium at screening
  • pregnant
  • body mass index <5% or >95%

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Low Dose Vitamin D
Subjects are randomized to take 200 IU vitamin D3 daily in this arm.
Drug: Supplemental Vitamin D
Subjects were randomized to either take 200 IU of vitamin D or 1000 IU of vitamin D daily for 11 weeks and labs were compared before and after.
Active Comparator: High Dose Vitamin D
Subjects are randomized to take 1000 IU vitamin D3 daily in this arm.
Drug: Supplemental Vitamin D
Subjects were randomized to either take 200 IU of vitamin D or 1000 IU of vitamin D daily for 11 weeks and labs were compared before and after.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Baseline 25 Hydroxy Vitamin D (25OHD) Levels
Time Frame: Baseline
25OHD will be drawn at baseline prior to starting vitamin D supplementation.
Baseline
Follow-up 25OHD Levels
Time Frame: 12 weeks
After 11weeks of treatment, repeat 25OHD levels will be drawn to assess subject response to vitamin D supplementation.
12 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Baseline Assessment of Bone Markers
Time Frame: Baseline
Bone specific alkaline phosphatase, CTx, and osteocalcin will be assessed at baseline prior to subjects starting vitamin D supplementation
Baseline
Assessment of Bone Markers at Follow-up
Time Frame: 12 weeks
After 11 weeks of vitamin D supplementation bone specific alkaline phosphatase, osteocalcin, and CTx will be repeated to see response to therapy.
12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Boston Children's Hospital

Investigators

  • Principal Investigator: Melissa Putman, MD, Childrens Hospital, Boston
  • Principal Investigator: Sarah Pitts, MD, Childrens Hospital, Boston

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2008

Primary Completion (Actual)

June 1, 2011

Study Completion (Actual)

June 1, 2011

Study Registration Dates

First Submitted

May 18, 2010

First Submitted That Met QC Criteria

May 18, 2010

First Posted (Estimate)

May 20, 2010

Study Record Updates

Last Update Posted (Actual)

June 4, 2018

Last Update Submitted That Met QC Criteria

May 1, 2018

Last Verified

May 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 08-06-0271

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Vitamin D Supplementation

Clinical Trials on Supplemental Vitamin D

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Dominican Republic

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe