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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
351
Treatment with multifortified bread for 120 days
Treatment with standard bread, fortified according to current Peruvian guidelines for 120 days
Centro de Salud Global
Tumbes, Peru
RECRUITINGAnemia
Percentage of volunteers reaching normal Hb levels during the study.
Time frame: 120 days
Hemoglobin levels
Variation in hemoglobin levels (mg/dL)
Time frame: 120 days
Serum ferritin levels
Variation in serum ferritin levels (ug/l)
Time frame: 120 days
Hemoglobin levels
Variation in hemoglobin levels (mg/dL)
Time frame: 90 days
Serum ferritin levels
Variation in serum ferritin levels (ug/l)
Time frame: 90 days
Body iron content
Variation in body iron content levels
Time frame: 120 days
Mean corpuscular volume
Variation in mean corpuscular volume (fL)
Time frame: 120 days
Red Blood Cell Distribution Width
Variation in Red Blood Cell Distribution Width (%)
Time frame: 120 days
Soluble transferrin receptor levels
Variation in soluble transferrin receptor levels (nmol/L)
Time frame: 120 days
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