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Vitamin D Supplementation in Healthy Adolescents

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ClinicalTrials.gov Identifier: NCT01126671
Recruitment Status : Completed
First Posted : May 20, 2010
Results First Posted : April 19, 2013
Last Update Posted : April 19, 2013
Sponsor:
Information provided by (Responsible Party):
Sarah Pitts, Children's Hospital Boston

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

Condition or disease Intervention/treatment Phase
Vitamin D Supplementation Drug: Supplemental Vitamin D Not Applicable

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 56 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Clinical Trial of Vitamin D Supplementation in Healthy Adolescents
Study Start Date : November 2008
Actual Primary Completion Date : June 2011
Actual Study Completion Date : June 2011

Resource links provided by the National Library of Medicine

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

Arm Intervention/treatment
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.



Primary Outcome Measures :
  1. Baseline 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 Outcome Measures :
  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.



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Ages Eligible for Study:   11 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
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%

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01126671


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

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
First Posted: May 20, 2010    Key Record Dates
Results First Posted: April 19, 2013
Last Update Posted: April 19, 2013
Last Verified: March 2013

Keywords provided by Sarah Pitts, Children's Hospital Boston:
vitamin D

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