Effect of Multiple Micronutrient Fortified Bread Consumption on Iron Deficiency Anemia in Women of Reproductive Age
- Conditions
- Iron Deficiency Anemia
- Interventions
- Other: MULTI-FORTIFIEDOther: FORTIFIED
- Registration Number
- NCT05103709
- Lead Sponsor
- Universidad Peruana Cayetano Heredia
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- Female
- Target Recruitment
- 351
- 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.
- 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,
- Smoking,
- Inability to sign informed consent,
- Consumption of nutritional supplements.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description MULTI-FORTIFIED MULTI-FORTIFIED The product to be evaluated is bread made from wheat flour fortified according to Peruvian national standards \[Riboflavin (0.18 mg), niacin (2.25 mg), thiamine (0.18 mg), folic acid (60ug), iron (4.2 mg)\] and a previtamin mix \[Vitamin A (240 ug), Vitamin b12 (0.72 ug), zinc (5.25 mg) per daily serving\]. Participants will receive 2 slices of bread a day for 120 days. It is supplied by Panificadora Bimbo del Peru S.A. FORTIFIED FORTIFIED The active comparator is bread fortified according to Peruvian national standards \[Riboflavin (0.18 mg), niacin (2.25 mg), thiamine (0.18 mg), folic acid (60ug), iron (4.2 mg)\]. Participants will receive 2 slices of bread a day for 120 days. It is supplied by Panificadora Bimbo del Peru S.A.
- Primary Outcome Measures
Name Time Method Anemia 120 days Percentage of volunteers reaching normal Hb levels during the study.
Hemoglobin levels 120 days Variation in hemoglobin levels (mg/dL)
Serum ferritin levels 120 days Variation in serum ferritin levels (ug/l)
- Secondary Outcome Measures
Name Time Method Hemoglobin levels 90 days Variation in hemoglobin levels (mg/dL)
Body iron content 120 days Variation in body iron content levels
Mean corpuscular volume 120 days Variation in mean corpuscular volume (fL)
Red Blood Cell Distribution Width 120 days Variation in Red Blood Cell Distribution Width (%)
Serum ferritin levels 90 days Variation in serum ferritin levels (ug/l)
Soluble transferrin receptor levels 120 days Variation in soluble transferrin receptor levels (nmol/L)
Trial Locations
- Locations (1)
Centro de Salud Global
🇵🇪Tumbes, Peru