CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 60 target
Drug / intervention
Vitamin Ddietary
Likely dose
Not stated in record
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Search/NCT00868738
NCT00868738N/ACompleted

Evaluation of Calcium, Vitamin D, Magnesium, and Zinc Absorption in Healthy Children 4 to 8 Years of Age

Baylor College of Medicine·interventional·Posted Mar 25, 2009·Updated Nov 2, 2011

In Brief

A clinical study evaluating Vitamin D for Mineral Absorption. Completed, enrolled 60 participants across 1 site.

Detailed Summary

The goal of our research is to provide data to enhance the development of nutritional guidelines, especially as related to mineral nutrition, in children. Using human experimentation, we are studying methods of delivering the key minerals of calcium, zinc and iron in the diet so as to optimize health outcomes. We will conduct a controlled trial of vitamin D supplementation to assess the effects of vitamin D status on calcium absorption in small children. We will evaluate the effects of differing intakes of zinc on zinc and copper absorption. These studies will utilize stable isotope techniques so as to provide accurate, practically applicable information which may be obtained from the study populations in a safe manner. These data will have global application and provide a strong basis for evidence-based nutritional recommendations to be developed. Objective #1: To evaluate the effects of supplemental vitamin D in enhancing calcium absorption in healthy children 4 to 8 yrs of age. Objective #2: Assess the absorption of magnesium and zinc in healthy children 4 to 8 yrs of age.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
Collaborators--

Timeline

N/ACompletedFinished
200920102011201220132014201520162017201820192020202120222023202420252026
First PostedMar 25, 2009
Enrollment StartMar 1, 2009
Primary CompletionAug 1, 2011
Study CompletionOct 1, 2011
TodayJul 2, 2026
Enrollment to primary: 2.4 yearsPosted 17.3 years ago

Interventions

Vitamin Ddietary

Subjects will be provided supplemental vitamin D3 (1000 IU) or placebo, given once daily (based on the stratification noted above). Vitamin D/placebo will be provided using a softgel or liquid. Subjects will be instructed to take the supplement daily for 8 weeks.