Effect of Multiple Micronutrient Fortified Bread Consumption on Iron Deficiency Anemia in Women of Reproductive Age: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 入组人数
- 351
- 试验地点
- 1
- 主要终点
- Anemia
研究概览
简要总结
The project aims to assess if consuming two slices of multi-fortified bread daily for 120 days is effective in reducing iron deficiency anemia in women of reproductive age through a three-arm randomized trial.
详细描述
Iron deficiency anemia (IDA) continues to be a public health priority in Peru and the world. The prevalence of the condition is high in women of reproductive age regardless of geographic area and socioeconomic status. Fortification of staple foods is recognized as a cost-effective strategy to reverse iron deficiency. In Peru, iron fortification of wheat flour and derived products is mandatory, but to date its effect on the IDA has not been evaluated. In recent years, evidence has been generated on the positive effect of zinc, vitamin A and vitamin B12 supplementation on hemoglobin (Hb) levels. This project is a three-arm randomized clinical trial that seeks to evaluate the effect of consuming two slices of bread fortified with a multivitamin premix (iron, folic acid, vitamin A, vitamin B12 and zinc) daily on iron deficiency anemia in non-pregnant women of reproductive age. As a control, one group will receive standard bread fortified according to Peruvian legislation and a third group will not receive treatment.
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
- Triple (Participant, Investigator, Outcomes Assessor)
盲法说明
Masking will be mixed. Since the third arm will not receive product of any kind it is not possible to mask the volunteers assigned to this group. The packaging of the products will be neutral to blind the volunteers in the groups that will receive products. The investigators will be blinded to randomization at all times.
入排标准
- 年龄范围
- 18 Years 至 35 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Ferritin levels < 13 ng/ml,
- •Hemoglobin levels between 8 g/dL and 11.9 g/dL,
- •No plans to move during the duration of the study,
- •Commitment not to become pregnant during the duration of the study,
- •Signed informed consent.
排除标准
- •Pregnancy,
- •Amenorrhea not related to pregnancy,
- •Breastfeeding,
- •Chronic diseases (active TB, HIV, cancer, asthma, liver disease, coronary heart disease, chronic renal disease),
- •Hemoglobin levels < 8 g/dL,
- •Bleeding in the 3 months prior to recruitment,
- •Inability to sign informed consent,
- •Consumption of nutritional supplements.
结局指标
主要结局
Anemia
时间窗: 120 days
Percentage of volunteers reaching normal Hb levels during the study.
Hemoglobin levels
时间窗: 120 days
Variation in hemoglobin levels (mg/dL)
Serum ferritin levels
时间窗: 120 days
Variation in serum ferritin levels (ug/l)
次要结局
- Hemoglobin levels(90 days)
- Body iron content(120 days)
- Mean corpuscular volume(120 days)
- Red Blood Cell Distribution Width(120 days)
- Serum ferritin levels(90 days)
- Soluble transferrin receptor levels(120 days)