Effects of Vitamin D Dose and Genotype of the Binding Protein in Infants and Children

Completed · Not applicable

Conditions studied: Vitamin D Deficiency

In brief

The purpose of this study is to determine if the vitamin D binding protein genotype influences circulating vitamin D levels and if it may have functional consequences on vitamin D activity.

Key facts

Study ID

NCT01050387

Run by

Yale University

People needed

193

Starts

2010-01-01

Expected to finish

2013-02-01

Last updated by the study team

2014-08-05

Who can join

Age: 1 and older, up to 6. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 6 months to 6 years of age
• healthy or free from any diseases or conditions that may affect nutritional status or bone metabolism
• willingness of family to participate in a 6-month study of vitamin D supplementation

You may not qualify if…

• Chronic disease
• Prematurity < 32 weeks gestational age
• Liver disease such as hepatitis or renal/urologic disease (e.g., recurrent urinary tract infection)
• Use of pharmacologic or prescription-level dosages of vitamin D or its metabolites. We will exclude users of any systemic glucocorticoid preparation and users of inhaled steroids that are considered greater than medium dose for age 4 yrs. Specifically, this would exclude users of over 1 mg/day of budesonide, and over 352 mcg/day of fluticasone.
• Current or recent (within 1 month) use of anticonvulsants or other medications known to affect bone and mineral homeostasis or alkaline phosphatase levels.

Where it is running

• Yale University School of Medicine — New Haven, Connecticut, United States

Full record on ClinicalTrials.gov

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