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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Steve Abrams, Baylor College of Medicine
ClinicalTrials.gov Identifier:
NCT00868738
First received: March 24, 2009
Last updated: November 1, 2011
Last verified: November 2011
  Purpose

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.


Condition Intervention
Mineral Absorption
Dietary Supplement: Vitamin D

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Basic Science
Official Title: Evaluation of Calcium, Vitamin D, Magnesium, and Zinc Absorption in Healthy Children 4 to 8 Years of Age

Resource links provided by NLM:


Further study details as provided by Baylor College of Medicine:

Primary Outcome Measures:
  • To evaluate the effects of supplemental vitamin D in enhancing calcium absorption in healthy children 4 to 8 yrs of age. [ Time Frame: End of the study ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Assess the absorption of magnesium and zinc in healthy children 4 to 8 yrs of age. [ Time Frame: End of the study ] [ Designated as safety issue: No ]

Estimated Enrollment: 60
Study Start Date: March 2009
Study Completion Date: October 2011
Primary Completion Date: August 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Vitamin D
Subjects will be provided supplemental vitamin D3 (1000 IU), given once daily as a softgel or liquid. Subjects will be instructed to take the supplement daily for 8 weeks.
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.
Placebo Comparator: Placebo
Subjects will be provided a placebo, given once daily as a softgel or liquid. Subjects will be instructed to take the supplement daily for 8 weeks.
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.

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   4 Years to 8 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Delivery at > or = 35.0 weeks gestation with birth weight > or = 2.5 kg
  • BMI: 10th - 90th percentile for age and gender
  • Ages 4.0 to 8.9 years
  • Ethnic distribution of greater Houston area
  • Usual calcium intake 600-1200 mg/d based on two 24-hour dietary recalls by phone
  • Any regularly taken (daily) vitamins and minerals must be stopped at least 1 month before starting the study

Exclusion Criteria:

  • History of any chronic illness.
  • Regularly taken (daily) medications (except seasonal allergies).
  • Avoidance of dairy products or meat in the diet.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00868738

Locations
United States, Texas
Baylor College of Medicine / Texas Children's Hospital
Houston, Texas, United States, 77030
Sponsors and Collaborators
Baylor College of Medicine
Investigators
Principal Investigator: Steve Abrams, MD Baylor College of Medicine
  More Information

Additional Information:
Publications:

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Steve Abrams, Professor, Baylor College of Medicine
ClinicalTrials.gov Identifier: NCT00868738     History of Changes
Other Study ID Numbers: H-24134, 6250-51000-045-00D
Study First Received: March 24, 2009
Last Updated: November 1, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by Baylor College of Medicine:
Calcium
Vitamin D
Magnesium
Zinc

Additional relevant MeSH terms:
Vitamin D
Ergocalciferols
Vitamins
Bone Density Conservation Agents
Physiological Effects of Drugs
Pharmacologic Actions
Micronutrients
Growth Substances

ClinicalTrials.gov processed this record on April 23, 2014