Iron Absorption in Vegetarian Children

NCT01489007 | Completed

• 1 other identifier: H-29640
• Study Type: observational
• Target: 29
• Locations: 1 country
• Sites: 1

Brief 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 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.

Conditions

Iron Absorption

Keywords

vegetarian; children; iron; iron absorption

Outcome Measures

Primary Outcomes (1)

• Effect of vegetarian diet on iron status

  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.

  At the final study visit (approximately 3-4 weeks after the start of the study)

Study Arms (1)

Vegetarian Children

Self-described lacto-ovo vegetarians for the past 6 months (Subjects who include a small amount of fish or chicken in the diet (not more than 2 servings total/week of both combined) will be allowed to participate in this study as these are not major iron contributors to the diet. Subjects must not have eaten any "red meat" however for 6 months.) Control subjects will be non-vegetarians.

Eligibility Criteria

• Age: 4 Years - 10 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

Community sample

You may qualify if:

• 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 10.9 years
• Ethnic distribution of greater Houston area
• Self-described lacto-ovo vegetarians for the past 6 months (Subjects who include a small amount of fish or chicken in the diet (not more than 2 servings total/week of both combined) will be allowed to participate in this study as these are not major iron contributors to the diet. Subjects must not have eaten any "red meat" however for 6 months.) Control subjects will be non-vegetarians.
• Any regularly taken (daily) iron supplements (with or without vitamin D) must be stopped at least 1 month before starting the study. Supplements of vitamin D with calcium, B12, and folate are allowed.

You may not qualify if:

• History of any chronic illness.
• Regularly taken (daily) medications (except seasonal allergies).
• Avoidance of dairy products in the diet (controls excluded).
• Females: has had first menstrual period.
• Control subjects will be non-vegetarians whose usual diet includes 2 servings/week or more of red meat.

Sponsors & Collaborators

• Baylor College of Medicine: lead

Study Sites (1)

Baylor College of Medicine / Texas Children's Hospital

Houston, Texas, 77030, United States

Location

Related Publications (2)

• Thane CW, Bates CJ, Prentice A. Risk factors for low iron intake and poor iron status in a national sample of British young people aged 4-18 years. Public Health Nutr. 2003 Aug;6(5):485-96. doi: 10.1079/PHN2002455.

  PMID: 12943565 BACKGROUND

• Craig WJ, Mangels AR; American Dietetic Association. Position of the American Dietetic Association: vegetarian diets. J Am Diet Assoc. 2009 Jul;109(7):1266-82. doi: 10.1016/j.jada.2009.05.027.

  PMID: 19562864 BACKGROUND

Study Officials

• Steven Abrams, MD

  Baylor College of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Pediatrics

Study Record Dates

• First Submitted: December 7, 2011
• First Posted: December 9, 2011
• Study Start: January 1, 2012
• Primary Completion: December 1, 2014
• Study Completion: December 1, 2014
• Last Updated: June 26, 2020

Record last verified: 2020-06

Locations

US (1)