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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Pilot Study of the Effect of Iron Fortified Rice on Iron Stores and Reticulocytes in Iron Deficient Anemic Women

Conditions
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Iron Deficiency Anemia

Intervention / Treatment
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* Other: Non-fortified rice
* Other: Iron-fortified Rice


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Regular Rice<br>2 servings per day of non-fortified rice | Other: Non-fortified rice<br>* 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.<br>|
| Other: Iron-fortified Rice<br>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. | Other: Iron-fortified Rice<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Baseline and 1 and 2 weeks following consumption of 2 servings | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Baseline and 1 and 2 weeks following consumption | 
| Transferrin | Changes in transferrin (a protein that transports iron in the body ) in the fortified rice group compared to the regular rice group. | Baseline and 1 and 2 weeks following consumption | 
| Hemoglobin | Changes in hemoglobin (The key protein in red blood cells to which oxygen attaches) in the fortified rice group compared to the regular rice group. | Baseline and 1 and 2 weeks following consumption | 
| Hematocrit | Changes in hematocrit (the proportion of your total blood volume that is composed of red blood cells) in the fortified rice group compared to the regular rice group. | Baseline and 1 and 2 weeks following consumption | 
| Mean Corpuscular Volume | Changes in mean corpuscular volume (the average red blood cell size in the fortified rice group compared to the regular rice group. | Baseline and 1 and 2 weeks following consumption | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Iron deficiency anemia, rice