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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: Completed study, sponsored by Baylor College of Medicine.
NCT01489007 is a clinical trial that has completed, run by Baylor College of Medicine. The registered enrollment target is 29 participants. According to ClinicalTrials.gov, the official US trial registry.
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
Primary Outcome
At the final study visit, 10 mL blood (2 tsp) will be drawn for measurement of iron nutritional parameters (e.g. hepcidin, ferritin, iron, TIBC, transferrin saturation, hemoglobin, hematocrit, and RBC indices) and iron isotope ratio measurement.
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 29 participants |
| Start Date | 2012-01 |
| Est. Completion | 2014-12 |
What the finished NCT01489007 record still lists
NCT01489007 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 29 participants, a relatively small participant target.
The record links to 0 conditions, and to 0 interventions.
NCT01489007 does not publish any study locations in the registry export this page uses.
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.
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