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NCT01489007 · ClinicalTrials.gov registry record

Iron Absorption in Vegetarian Children

A clinical trial, sponsored by Baylor College of Medicine.

Completed
Registry status
29
Enrollment target

NCT01489007 is a clinical trial that has completed, run by Baylor College of Medicine. The registered enrollment target is 29 participants.

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The verdict

NCT01489007 has completed, sponsored by Baylor College of Medicine.

COMPLETED
Registry status
29 participants
Enrollment target

Study Summary

Few areas are more controversial in pediatric nutrition than the role of a vegetarian diet for children. Advocates make strong health claims whereas others have expressed safety concerns, especially regarding iron nutrition. The frequency of vegetarianism among children is said to be rapidly increasing although clear data are not available. Surveys of children in the US age 8 to 18 reported in the media find that about 3-5% of children are lacto-ovo vegetarian, with some fish or chicken products in the diet. This is a substantial proportion that is very likely to increase over the next few years with essentially no nutrient metabolism data related to this population. One of the principal concerns with a lacto-ovo vegetarian diet, as preferred by many children, is the lack of heme iron in the diet. A key question that can be evaluated in children is whether iron status is in fact affected by a lacto-ovo vegetarian diet. According to the American Academy of Pediatrics (AAP Pediatric Nutrition Handbook, 6th Edition, 2008), vegetarian diets can provide appropriate nutrition for children. Depending on the level of dietary restriction, fortified foods or supplements may be necessary during different life stages. In addition, strict vegetarian children may have slightly higher protein needs compared to non-vegetarian children due to decreased protein digestibility in certain plants. The AAP further recommends that children 4-8 years old consume a minimum of five servings per day of beans/nuts/seeds/eggs and six servings per day of calcium-rich foods. To evaluate this issue, the investigators will use a stable isotope method to directly assess iron status. It is increasingly recognized that the ability to absorb iron when given with vitamin C is a highly accurate measurement of iron status and may be a true gold standard in this regard. In this planned study, investigators will be able to assess both reference dose iron absorption and standard biochemical markers of iron

Trial Details

FieldValue
Enrollment Target 29 participants
Start Date 2012-01
Est. Completion 2014-12

Sponsor

Baylor College of Medicine

616 total trials

What the Registry Record Tells You About NCT01489007

The ClinicalTrials.gov registry entry for NCT01489007 describes a study currently listed as completed, categorized as an unspecified phase. The registered enrollment target is 29 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Baylor College of Medicine, which has 616 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 0 interventions.

NCT01489007 reports 0 study locations.

Frequently Asked Questions

What is clinical trial NCT01489007 about?

NCT01489007 is a clinical study titled "Iron Absorption in Vegetarian Children". Few areas are more controversial in pediatric nutrition than the role of a vegetarian diet for children. Advocates make strong health claims whereas others have expressed safety concerns, especially regarding iron nutrition. The frequency of vegetarianism among children is said to be rapidly increas...

What is the current status of trial NCT01489007?

This trial is currently completed. The enrollment target is 29 participants. The study started on 2012-01. Estimated completion is 2014-12.

Who is sponsoring clinical trial NCT01489007?

This trial is sponsored by Baylor College of Medicine, which has 616 total clinical trials registered on ClinicalTrials.gov.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.