Mineral Absorption Clinical Trial
Official title:
Evaluation of Calcium, Vitamin D, Magnesium, and Zinc Absorption in Healthy Children 4 to 8 Years of Age
Verified date | November 2011 |
Source | Baylor College of Medicine |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Institutional Review Board |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 60 |
Est. completion date | October 2011 |
Est. primary completion date | August 2011 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Both |
Age group | 4 Years to 8 Years |
Eligibility |
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. |
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Basic Science
Country | Name | City | State |
---|---|---|---|
United States | Baylor College of Medicine / Texas Children's Hospital | Houston | Texas |
Lead Sponsor | Collaborator |
---|---|
Baylor College of Medicine |
United States,
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* Note: There are 33 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | To evaluate the effects of supplemental vitamin D in enhancing calcium absorption in healthy children 4 to 8 yrs of age. | End of the study | No | |
Secondary | Assess the absorption of magnesium and zinc in healthy children 4 to 8 yrs of age. | End of the study | No |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
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Pharmacokinetic Analysis of Nutrient Absorption From a Novel Liposomal Multivitamin/Mineral Formulation
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