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Completed No phase listed Observational Accepts healthy volunteers

Iron Absorption in Vegetarian Children

ClinicalTrials.gov ID: NCT01489007

Public ClinicalTrials.gov record NCT01489007. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

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Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

Evaluation of Iron Absorption in Healthy Vegetarian Children 4 to 10 Years of Age

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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 status in a group of lacto-ovo vegetarians and compare them with age- and gender-matched children on a non-vegetarian diet. These data can be important in determining if iron status is decreased in lacto-ovo vegetarians and will serve as a basis for future interventions and evaluations if a difference is found.

Study identification

NCT ID
NCT01489007
Recruitment status
Completed
Study type
Observational
Phase
Not listed
Lead sponsor
Baylor College of Medicine
Other
Enrollment
29 participants

Conditions and interventions

Interventions

Not listed

Eligibility (public fields only)

Age range
4 Years to 10 Years
Sex
All
Healthy volunteers
Accepts healthy volunteers

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Dec 31, 2011
Primary completion
Nov 30, 2014
Completion
Nov 30, 2014
Last update posted
Jun 25, 2020

2012 – 2014

United States locations

U.S. sites
1
U.S. states
1
U.S. cities
1
Facility City State ZIP Site status
Baylor College of Medicine / Texas Children's Hospital Houston Texas 77030

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT01489007, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Jun 25, 2020 · Synced Sep 5, 2026

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The complete protocol, eligibility criteria, and contact information for NCT01489007 live on ClinicalTrials.gov.

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