Vitamin D Supplementation in Healthy Adolescents

Boston Children's Hospital

Status: Completed

Conditions: Vitamin D Supplementation

Treatments: Drug: Supplemental Vitamin D

Study type: Interventional

Funder types: Other

Identifiers

NCT01126671

08-06-0271

Details and patient eligibility

About

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

Full 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.

Enrollment: 56 patients

Sex: All

Ages: 11 to 18 years old

Volunteers: Accepts Healthy Volunteers

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%

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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56 participants in 2 patient groups

Low Dose Vitamin D

Active Comparator group

Description:

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

Treatment:

Drug: Supplemental Vitamin D

High Dose Vitamin D

Active Comparator group

Description:

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

Treatment:

Drug: Supplemental Vitamin D