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Vitamin D Supplementation in Healthy Adolescents

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Sarah Pitts, Children's Hospital Boston
ClinicalTrials.gov Identifier:
NCT01126671
First received: May 18, 2010
Last updated: March 8, 2013
Last verified: March 2013
History of Changes
  Purpose

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


Condition Intervention
Vitamin D Supplementation
 Drug: Supplemental Vitamin D

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Clinical Trial of Vitamin D Supplementation in Healthy Adolescents

Resource links provided by NLM:

MedlinePlus related topics: Vitamin D
Drug Information available for: Vitamin D
U.S. FDA Resources

Further study details as provided by Children's Hospital Boston:

Primary Outcome Measures:
  • Baseline 25OHD Levels [ Time Frame: Baseline ] [ Designated as safety issue: No ]
    25OHD will be drawn at baseline prior to starting vitamin D supplementation.

  • Follow-up 25OHD Levels [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    After 11weeks of treatment, repeat 25OHD levels will be drawn to assess subject response to vitamin D supplementation.


Secondary Outcome Measures:
  • Baseline Assessment of Bone Markers [ Time Frame: Baseline ] [ Designated as safety issue: No ]
    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 [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    After 11 weeks of vitamin D supplementation bone specific alkaline phosphatase, osteocalcin, and CTx will be repeated to see response to therapy.


Enrollment: 56
Study Start Date: November 2008
Study Completion Date: June 2011
Primary Completion Date: June 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Low Dose Vitamin D
Subjects are randomized to one of two supplemental vitamin D arms.
 Drug: Supplemental Vitamin D
Two doses of daily supplemental vitamin D taken for 11 weeks.
Active Comparator: High Dose Vitamin D
Subjects are randomized to one of two supplemental vitamin D treatment arms.
 Drug: Supplemental Vitamin D
Two doses of daily supplemental vitamin D taken for 11 weeks.

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.

  Eligibility

Ages Eligible for Study:   11 Years to 18 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 11-18yo
  • healthy

Exclusion Criteria:

  • chronic disease
  • use of medication known to effect bone or vitamin D metabolism
  • abnormal vitamin D or calcium at screening
  • pregnant
  • BMI<5% or >95%
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01126671

Locations
United States, Massachusetts
Children's Hospital Boston
Boston, Massachusetts, United States, 02115
Sponsors and Collaborators
Children's Hospital Boston
Investigators
Principal Investigator: Melissa Putman, MD Childrens Hospital, Boston
Principal Investigator: Sarah Pitts, MD Childrens Hospital, Boston
  More Information

No publications provided

Responsible Party: Sarah Pitts, Attending Physician, Children's Hospital Boston
ClinicalTrials.gov Identifier: NCT01126671     History of Changes
Other Study ID Numbers: 08-06-0271
Study First Received: May 18, 2010
Results First Received: March 8, 2013
Last Updated: March 8, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Children's Hospital Boston:
vitamin D

Additional relevant MeSH terms:
Vitamin D
Ergocalciferols
Vitamins
Bone Density Conservation Agents
 Physiological Effects of Drugs
Pharmacologic Actions
Micronutrients
Growth Substances

ClinicalTrials.gov processed this record on May 21, 2013