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Evaluation of Calcium, Vitamin D, Magnesium, and Zinc Absorption in Children

NCT00868738 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2011-11-02

No results posted yet for this study

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.

Conditions

  • Mineral Absorption

Interventions

DIETARY_SUPPLEMENT

Vitamin D

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.

Sponsors & Collaborators

  • Baylor College of Medicine

    lead OTHER

Principal Investigators

  • Steve Abrams, MD · Baylor College of Medicine

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
4 Years
Max Age
8 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2009-03-31
Primary Completion
2011-08-31
Completion
2011-10-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00868738 on ClinicalTrials.gov