Effect of Vitamin C on Iron Absorption
Information source: Baylor College of Medicine
ClinicalTrials.gov processed this data on August 20, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Iron Deficiency
Intervention: Vitamin C (Dietary Supplement)
Phase: N/A
Status: Completed
Sponsored by: Baylor College of Medicine Official(s) and/or principal investigator(s): Steven A Abrams, MD, Principal Investigator, Affiliation: Baylor College of Medicine
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.
Clinical Details
Official title: Effect of Ascorbic Acid on Iron Absorption From Ferrous Fumarate
Study design: Allocation: Randomized, Endpoint Classification: Bio-availability Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Basic Science
Primary outcome: Clarify the effect, if any, of ascorbic acid on ferrous fumarate absorption
Detailed description:
This study involves four outpatient visits. Two test meals will be given (during visits 2
and 3) and two blood draws will be done (visits 3 and 4). A 2-3 hour fast prior to the visit
is required. Therefore, subjects may come in first thing in the morning (for breakfast
meal), at lunch, or in the afternoon (snack). Subjects may be scheduled to come in during
the week or on weekends; however, each individual subject will need to return at the same
time of day for each subsequent visit. Visit procedures are described below.
Visit 1: Subjects will be admitted to the GCRC as an outpatient after a 2-3h fast and given
a reference dose of 1mg iron-58 sulfate as an aqueous solution with 50mg ascorbic acid. They
will be observed for 2h after this dose and water will be freely available. No food will be
allowed. After 2h subjects will be discharged home and food allowed.
Visit 2: One to 10 days later subjects will be again admitted as an outpatient after a 2-3h
fast. They 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. The order of
ascorbic acid supplementation or non-supplementation will be decided by random. No food will
be allowed after the meal. After 2h subjects will be discharged home and food allowed.
Visit 3: Two weeks (+/- 3 days) later they will be readmitted after a 2-3h fast and the
second visit repeated. 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. Immediately prior
to administration of the second test meal, 10mL blood will be drawn for measurement of iron
nutritional parameters (e. g. CBC, serum ferritin) and iron isotope ratio measurement.
Incorporation of iron-57 will be used to calculate iron absorption from the test meal given
during visit 2, and incorporation of iron-58 used to measure absorption from the reference
dose (a measure of iron status). No food will be allowed after the meal and blood draw.
After 2h subjects will be discharged home and food allowed.
Visit 4: Two weeks (+/- 3 days) later subjects will be admitted for a 10mL blood draw as
described above. Incorporation of iron-57 will reflect the absorption of ferrous fumarate
from the test meal given during visit 3.
Eligibility
Minimum age: 4 Years.
Maximum age: 8 Years.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- Healthy children
- 4-8. 0y 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.
Exclusion Criteria:
- 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
Locations and Contacts
Children's Nutrition Research Center, Houston, Texas 77057, United States
Additional Information
Children's Nutrition Research Center
Starting date: January 2008
Last updated: June 3, 2008
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