Pilot Study of the Effect of Iron Fortified Rice on Iron Stores and Reticulocytes in Iron Deficient Anemic Women
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 17
- 试验地点
- 2
- 主要终点
- Change in reticulocyte count.
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Are a healthy woman.
- •Are between 18 and 50 years of age.
- •Have iron deficient anemia.
排除标准
- •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
研究组 & 干预措施
Regular Rice
2 servings per day of non-fortified rice
干预措施: Non-fortified rice (Other)
Iron-fortified Rice
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.
干预措施: Iron-fortified Rice (Other)
结局指标
主要结局
Change in reticulocyte count.
时间窗: 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.
次要结局
- Mean Corpuscular Volume(Baseline and 1 and 2 weeks following consumption)
- Hemoglobin(Baseline and 1 and 2 weeks following consumption)
- Transferrin(Baseline and 1 and 2 weeks following consumption)
- Hematocrit(Baseline and 1 and 2 weeks following consumption)
- Changes in serum iron(Baseline and 1 and 2 weeks following consumption)
研究者
Frank Greenway
Principal Investigator
Pennington Biomedical Research Center