Vitamin D Supplementation in Healthy Adolescents
Clinical Trial of Vitamin D Supplementation in Healthy Adolescents
1 other identifier
interventional
56
1 country
1
Brief Summary
This double blind, randomized controlled trial compares two supplemental doses of vitamin D in health adolescents.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Nov 2008
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2008
CompletedFirst Submitted
Initial submission to the registry
May 18, 2010
CompletedFirst Posted
Study publicly available on registry
May 20, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2011
CompletedResults Posted
Study results publicly available
April 19, 2013
CompletedJune 4, 2018
May 1, 2018
2.6 years
May 18, 2010
March 8, 2013
May 1, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Baseline 25 Hydroxy Vitamin D (25OHD) Levels
25OHD will be drawn at baseline prior to starting vitamin D supplementation.
Baseline
Follow-up 25OHD Levels
After 11weeks of treatment, repeat 25OHD levels will be drawn to assess subject response to vitamin D supplementation.
12 weeks
Secondary Outcomes (2)
Baseline Assessment of Bone Markers
Baseline
Assessment of Bone Markers at Follow-up
12 weeks
Study Arms (2)
Low Dose Vitamin D
ACTIVE COMPARATORSubjects are randomized to take 200 IU vitamin D3 daily in this arm.
High Dose Vitamin D
ACTIVE COMPARATORSubjects are randomized to take 1000 IU vitamin D3 daily in this arm.
Interventions
Subjects were randomized to either take 200 IU of vitamin D or 1000 IU of vitamin D daily for 11 weeks and labs were compared before and after.
Eligibility Criteria
You may qualify if:
- years old
- healthy
You may not qualify if:
- chronic disease
- use of medication known to effect bone or vitamin D metabolism
- abnormal vitamin D or calcium at screening
- pregnant
- body mass index \<5% or \>95%
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Children's Hospital Boston
Boston, Massachusetts, 02115, United States
Related Publications (1)
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.
PMID: 23608721BACKGROUND
Results Point of Contact
- Title
- Dr. Sarah Pitts
- Organization
- Boston Children's Hospital
Study Officials
- PRINCIPAL INVESTIGATOR
Melissa Putman, MD
Childrens Hospital, Boston
- PRINCIPAL INVESTIGATOR
Sarah Pitts, MD
Childrens Hospital, Boston
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Attending Physician
Study Record Dates
First Submitted
May 18, 2010
First Posted
May 20, 2010
Study Start
November 1, 2008
Primary Completion
June 1, 2011
Study Completion
June 1, 2011
Last Updated
June 4, 2018
Results First Posted
April 19, 2013
Record last verified: 2018-05