Vitamin D Supplementation in Healthy Adolescents

Vitamin D Supplementation Clinical Trial

Official title:

Clinical Trial of Vitamin D Supplementation in Healthy Adolescents

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01126671
• Other study ID #: 08-06-0271
• Status: Completed
• Phase: N/A
• Start date: November 2008
• Est. completion date: June 2011

Study information

• Verified date: May 2018
• Source: Boston Children’s Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 56
• Est. completion date: June 2011
• Est. primary completion date: June 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 11 Years to 18 Years

Eligibility

Inclusion Criteria:

• 11-18 years old

• healthy

Exclusion Criteria:

• 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%

Related Conditions & MeSH terms

• Vitamin D Supplementation

Intervention

Drug:
• Supplemental Vitamin D
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.

Locations

Country	Name	City	State
United States	Children's Hospital Boston	Boston	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Boston Children’s Hospital

Country where clinical trial is conducted

United States, 

References & 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Baseline 25 Hydroxy Vitamin D (25OHD) Levels	25OHD will be drawn at baseline prior to starting vitamin D supplementation.	Baseline
Primary	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	Baseline Assessment of Bone Markers	Bone specific alkaline phosphatase, CTx, and osteocalcin will be assessed at baseline prior to subjects starting vitamin D supplementation	Baseline
Secondary	Assessment of Bone Markers at Follow-up	After 11 weeks of vitamin D supplementation bone specific alkaline phosphatase, osteocalcin, and CTx will be repeated to see response to therapy.	12 weeks