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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00868738
Recruitment Status : Completed
First Posted : March 25, 2009
Last Update Posted : November 2, 2011
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief 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.


Condition or disease Intervention/treatment
Mineral Absorption Dietary Supplement: Vitamin D

  Show Detailed Description

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, 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
Study Start Date : March 2009
Primary Completion Date : August 2011
Study Completion Date : October 2011

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
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.


Outcome Measures

Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. Assess the absorption of magnesium and zinc in healthy children 4 to 8 yrs of age. [ Time Frame: End of the study ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   4 Years to 8 Years   (Child)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Publications:

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
First Posted: March 25, 2009    Key Record Dates
Last Update Posted: November 2, 2011
Last Verified: November 2011

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

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