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

May 18, 2010
March 8, 2013
November 2008
June 2011   (final data collection date for primary outcome measure)
  • 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.
Same as current
Complete list of historical versions of study NCT01126671 on ClinicalTrials.gov Archive Site
  • 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.
Same as current
Not Provided
Not Provided
 
Vitamin D Supplementation in Healthy Adolescents
Clinical Trial of Vitamin D Supplementation in Healthy Adolescents

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

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Vitamin D Supplementation
Drug: Supplemental Vitamin D
Two doses of daily supplemental vitamin D taken for 11 weeks.
  • Active Comparator: Low Dose Vitamin D
    Subjects are randomized to one of two supplemental vitamin D arms.
    Intervention: Drug: Supplemental Vitamin D
  • Active Comparator: High Dose Vitamin D
    Subjects are randomized to one of two supplemental vitamin D treatment arms.
    Intervention: Drug: Supplemental Vitamin D
Putman MS, Pitts SA, Milliren CE, Feldman HA, Reinold K, Gordon CM. A randomized clinical trial of vitamin D supplementation in healthy adolescents. J Adolesc Health. 2013 May;52(5):592-8. doi: 10.1016/j.jadohealth.2012.10.270. Epub 2012 Dec 23.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
56
June 2011
June 2011   (final data collection date for primary outcome measure)

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%
Both
11 Years to 18 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01126671
08-06-0271
No
Sarah Pitts, Children's Hospital Boston
Children's Hospital Boston
Not Provided
Principal Investigator: Melissa Putman, MD Childrens Hospital, Boston
Principal Investigator: Sarah Pitts, MD Childrens Hospital, Boston
Children's Hospital Boston
March 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP