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Vitamin D Supplementation in Healthy Adolescents

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01126671
First Posted: May 20, 2010
Last Update Posted: April 19, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Sarah Pitts, Children's Hospital Boston
  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
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

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Baseline 25OHD Levels [ Time Frame: Baseline ]
    25OHD will be drawn at baseline prior to starting vitamin D supplementation.

  • 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:
  • 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

  • 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.


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

Information from the National Library of Medicine

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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%
  Contacts and Locations
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
  More Information

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 Submitted: May 18, 2010
First Posted: May 20, 2010
Results First Submitted: March 8, 2013
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


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