Vitamin D Supplementation in Healthy Adolescents

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

Detailed Description
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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.

Official Title
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Clinical Trial of Vitamin D Supplementation in Healthy Adolescents

Conditions
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Vitamin D Supplementation

Intervention / Treatment
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* Drug: Supplemental Vitamin D


Participation Criteria
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Eligibility Criteria
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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%

Ages Eligible for Study
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Minimum Age: 11 Years
Maximum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Low Dose Vitamin D<br>Subjects are randomized to take 200 IU vitamin D3 daily in this arm. | Drug: Supplemental Vitamin D<br>* 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.<br>|
| Active Comparator: High Dose Vitamin D<br>Subjects are randomized to take 1000 IU vitamin D3 daily in this arm. | Drug: Supplemental Vitamin D<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Baseline 25 Hydroxy Vitamin D (25OHD) Levels | 25OHD will be drawn at baseline prior to starting vitamin D supplementation. | Baseline | 
| Follow-up 25OHD Levels | 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 | 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 | After 11 weeks of vitamin D supplementation bone specific alkaline phosphatase, osteocalcin, and CTx will be repeated to see response to therapy. | 12 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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vitamin D