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
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 by Children's Hospital Boston

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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:
Ergocalciferols
Vitamin D
Vitamins
Bone Density Conservation Agents
Growth Substances
Micronutrients
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on October 23, 2014