Vitamin D Supplementation in Healthy Adolescents

Not Applicable

Completed

• Conditions: Vitamin D Supplementation
• Interventions: Drug: Supplemental Vitamin D

• Registration Number: NCT01126671
• Lead Sponsor: Boston Children's Hospital

Brief Summary

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

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 Timeline

• Study Start: 2008-11
• Study First Submitted: 2010-05-18
• Study First Submitted QC: 2010-05-18
• Study First Posted: 2010-05-20
• Primary Completion: 2011-06
• Study Completion: 2011-06
• Results First Submitted: 2013-03-08
• Results First Submitted QC: 2013-03-08
• Results First Posted: 2013-04-19
• Status Verified: 2018-05
• Last Update Submitted: 2018-05-01
• Last Update Posted: 2018-06-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 56

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Low Dose Vitamin D	Supplemental Vitamin D	Subjects are randomized to take 200 IU vitamin D3 daily in this arm.
High Dose Vitamin D	Supplemental Vitamin D	Subjects are randomized to take 1000 IU vitamin D3 daily in this arm.

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Children's Hospital Boston; 🇺🇸 Boston, Massachusetts, United States