Vitamin D Supplementation in Healthy Adolescents

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

56 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-11-30

Study Completion Date

2011-06-30

Brief Summary

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

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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.

Conditions

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Vitamin D Supplementation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Low Dose Vitamin D

Subjects are randomized to take 200 IU vitamin D3 daily in this arm.

Group Type ACTIVE_COMPARATOR

Supplemental Vitamin D

Intervention Type DRUG

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.

High Dose Vitamin D

Subjects are randomized to take 1000 IU vitamin D3 daily in this arm.

Group Type ACTIVE_COMPARATOR

Supplemental Vitamin D

Intervention Type DRUG

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.

Interventions

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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.

Intervention Type DRUG

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%

Minimum Eligible Age

11 Years

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes