Iron Deficiency Anemia
Conditions
Keywords
Iron deficiency anemia, rice
Brief summary
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
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.
Interventions
OTHERNon-fortified rice
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.
OTHERIron-fortified Rice
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.
Sponsors
The Wright Group in Crowley, LA
Pennington Biomedical Research Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 50 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in reticulocyte count. | Baseline and 1 and 2 weeks following consumption of 2 servings | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Changes in serum iron | Baseline and 1 and 2 weeks following consumption | 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. |
| Transferrin | Baseline and 1 and 2 weeks following consumption | Changes in transferrin (a protein that transports iron in the body ) in the fortified rice group compared to the regular rice group. |
| Hemoglobin | Baseline and 1 and 2 weeks following consumption | 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. |
| Hematocrit | Baseline and 1 and 2 weeks following consumption | 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. |
| Mean Corpuscular Volume | Baseline and 1 and 2 weeks following consumption | Changes in mean corpuscular volume (the average red blood cell size in the fortified rice group compared to the regular rice group. |
Countries
United States
Outcome results
None listed