Pilot Study of the Effect of Iron Fortified Rice in Iron Deficient Anemic Women

Pennington Biomedical Research Center17 enrolled

Overview

The purpose of this study is to see if rice enriched in iron will help women with iron-deficient anemia restore their blood counts more efficiently than the standard rice not enriched with iron.

The study will consist of 1 screening visit and 3 study visits. The two-week study will be scheduled to be between menses. You will then be assigned to eat regular rice dishes or rice dishes fortified with iron for the two-week period. The assignment to the rice group will be made randomly (like flipping a coin). Your chance of being in either rice group will be 50:50. You will be given 14 frozen rice meals in styrofoam containers to take home. You will be expected to eat two rice dishes per day for the next study week and to bring the empty containers to your next study visit.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Iron Deficiency Anemia

Interventions

Non-fortified riceOTHER

Consumption of 2 servings of Non-fortified rice per day in women with iron deficiency anemia and measure serum iron and transferrin at baseline and end of study.

Iron-fortified RiceOTHER

Consumption of 2 servings of Iron-fortified rice per day in women with iron deficiency anemia and measure serum iron and transferrin at baseline and end of study.

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 50 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Are a healthy woman. * Are between 18 and 50 years of age. * Have iron deficient anemia. Exclusion Criteria: * Are pregnant or nursing. * Are taking a medication or supplement to treat iron deficiency. * Treatment for iron deficiency within the past month * Type 1 or type 2 diabetes * Ongoing cancer * Active auto-immune disease * Chronic infections (e.g. HIV/AIDS, hepatitis B, hepatitis C) * Chronic kidney disease * Liver cirrhosis * History of drug or alcohol abuse within the past 6 months * History of eating disorder within the past 6 months * Any gastrointestinal surgery affecting nutrient absorption

Locations (1)

Pennington Biomedical Research Center

Baton Rouge, Louisiana, United States

Outcomes

Primary Outcomes

Change in reticulocyte count.

Change in reticulocyte typically count in the iron-fortified rice group compared to the regular rice group. This is a test that measures how rapidly immature red blood cells called reticulocytes are made by the bone marrow and released into the blood.

Time frame: Baseline and 1 and 2 weeks following consumption of 2 servings

Secondary Outcomes

Changes in serum iron

Changes in serum iron is a medical laboratory test that measures the amount of circulating iron in the blood; in the fortified rice group compared to the regular rice group.