Effect of Vitamin C on Iron Absorption

NCT00570895 | Completed

• 1 other identifier: H-21063
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 1

Brief Summary

Iron deficiency is a common health problem worldwide. Ferrous fumarate (a form of iron) is often added to foods in an effort to prevent iron deficiency. Vitamin C can improve the amount of iron that the body absorbs, therefore it is often added to foods too. However, we don't know if vitamin C really increases the absorption of iron from ferrous fumarate. This study will measure the iron absorption in children from a meal containing some ferrous fumarate with and without vitamin C. The study will include 4 visits to the Children's Nutrition Research Center in Houston, TX.

Conditions

Iron Deficiency

Keywords

Iron; Absorption; Ascorbic Acid; Ferrous Fumarate

Outcome Measures

Primary Outcomes (1)

• Clarify the effect, if any, of ascorbic acid on ferrous fumarate absorption

  2 weeks

Study Arms (2)

A

ACTIVE COMPARATOR

Subjects in Arm A will receive the juice without ascorbic acid in addition to the muffin with ferrous fumarate.

Dietary Supplement: Vitamin C

B

ACTIVE COMPARATOR

Subjects in Arm A will receive the juice with 25mg ascorbic acid in addition to the muffin with ferrous fumarate

Dietary Supplement: Vitamin C

Interventions

Vitamin C DIETARY_SUPPLEMENT

Visit 1: Subjects will receive 1mg iron-58 sulfate as an aqueous solution with 50mg ascorbic acid. Visit 2: Subjects will consume a meal of a bread muffin labelled with 4mg of iron-57 as ferrous fumarate, and a glass of apple juice containing 0 or 25mg ascorbic acid. Visit 3: During this admission the apple juice will contain either 0 or 25mg ascorbic acid, the opposite of what was given to the subject in visit 2.

A; B

Eligibility Criteria

• Age: 4 Years - 8 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Healthy children
• y of age
• No chronic medical problems
• Not on regular medications
• Subjects on vitamin or mineral supplementation will be eligible as long as they discontinue the supplements two weeks prior to the first visit, until the end of the fourth visit.

You may not qualify if:

• Chronic medical problems that interfere with nutrient absorption
• History of prematurity (\<37 wks gestational age)
• History of birth weight \<2500g
• Current height-for-age or weight-for-age below the 5th centile or above the 95th centile

Sponsors & Collaborators

• Baylor College of Medicine: lead

Study Sites (1)

Children's Nutrition Research Center

Houston, Texas, 77057, United States

Location

Related Publications (1)

• Balay KS, Hawthorne KM, Hicks PD, Griffin IJ, Chen Z, Westerman M, Abrams SA. Orange but not apple juice enhances ferrous fumarate absorption in small children. J Pediatr Gastroenterol Nutr. 2010 May;50(5):545-50. doi: 10.1097/MPG.0b013e3181b1848f.

  PMID: 20639713 DERIVED

MeSH Terms

Conditions

Iron Deficiencies

Interventions

Ascorbic Acid

Condition Hierarchy (Ancestors)

Iron Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Sugar Acids; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Hydroxy Acids; Carbohydrates

Study Officials

• Steven A Abrams, MD

  Baylor College of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: December 7, 2007
• First Posted: December 11, 2007
• Study Start: January 1, 2008
• Primary Completion: April 1, 2008
• Study Completion: May 1, 2008
• Last Updated: June 26, 2020

Record last verified: 2020-06

Locations

US (1)