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Completed

NCT Number: NCT01126671

Vitamin D Supplementation in Healthy Adolescents

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

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Key information

Conditions

Vitamin D Supplementation

Age range

11 year–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Children's Hospital Boston

Boston, Massachusetts, 02115, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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%

Treatment and study plan

Supplemental Vitamin D

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.

Primary outcomes

  1. Baseline 25 Hydroxy Vitamin D (25OHD) Levels

    Time frame: Baseline

    25OHD will be drawn at baseline prior to starting vitamin D supplementation.

  2. 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.

Secondary outcomes

  1. 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

  2. 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.

Sponsors and collaborators

Lead sponsor

Boston Children's Hospital

Other

Registry information

Official study title

Clinical Trial of Vitamin D Supplementation in Healthy Adolescents

Important dates

Study start
2008
Primary completion
2011
Study completion
2011
First posted
May 20, 2010
Registry last updated
Jun 4, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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