Status:
COMPLETED
Defining Vitamin D Insufficiency in School Age Children: A Randomized Placebo Controlled Trial of Vitamin D3
Lead Sponsor:
University of Pittsburgh
Conditions:
Healthy
Eligibility:
All Genders
8-14 years
Phase:
PHASE1
Brief Summary
The study objective is to characterize the threshold levels of serum 25-hydroxyvitamin D for the definition of vitamin D insufficiency in 8-14 year old African American and Caucasian children. We pro...
Detailed Description
Epidemiologic and clinical data document a high prevalence of vitamin D insufficiency among adults and adolescents in the US. Vitamin D insufficiency during childhood has the potential to impact the a...
Eligibility Criteria
Inclusion
- Age: 8-14 years
- Race: African American or Caucasian
- Children not taking multivitamins for at least 1 month before enrollment and agree not to start any multivitamin supplements during the 6-month trial period.
- Children who are on multivitamins can be considered for enrollment only if they are able to and agree to stop their multivitamin tablet for a 1 month washout period prior to enrollment.
- Absence of chronic diseases that could affect growth or calcium or vitamin D metabolism
Exclusion
- Hepatic or renal disease
- Metabolic rickets
- Malabsorptive disorders (Crohn's disease, cystic fibrosis and celiac disease) or cancer
- Treatment with anticonvulsants or systemic glucocorticoids
Key Trial Info
Start Date :
October 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2011
Estimated Enrollment :
157 Patients enrolled
Trial Details
Trial ID
NCT00732758
Start Date
October 1 2008
End Date
October 1 2011
Last Update
December 29 2015
Active Locations (1)
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1
Children's Hospital of Pittsburgh
Pittsburgh, Pennsylvania, United States, 15217