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

Pennington Biomedical Research Center

Status: Completed

Conditions: Iron Deficiency Anemia

Treatments: Other: Iron-fortified Rice; Other: Non-fortified rice

Study type: Interventional

Funder types: Other

Identifiers

NCT01658488

PBRC 12026

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 17 patients

Sex: Female

Ages: 18 to 50 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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17 participants in 2 patient groups

Regular Rice

Other group

Description:

2 servings per day of non-fortified rice

Treatment:

Other: Non-fortified rice

Iron-fortified Rice

Other group

Description:

2 servings per day of Rice enriched in iron for women with iron-deficient anemia to restore their blood counts more efficiently than the standard rice not enriched with iron.

Treatment:

Other: Iron-fortified Rice