Effect of Multiple Micronutrient Fortified Bread Consumption on Iron Deficiency Anemia in Women of Reproductive Age

Study Overview
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Brief Summary
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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
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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.

Official Title
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Effect of Multiple Micronutrient Fortified Bread Consumption on Iron Deficiency Anemia in Women of Reproductive Age: A Randomized Controlled Trial

Conditions
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Iron Deficiency Anemia

Intervention / Treatment
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* Other: MULTI-FORTIFIED
* Other: FORTIFIED


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. Exclusion Criteria: 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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 35 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: MULTI-FORTIFIED<br>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. | Other: MULTI-FORTIFIED<br>* Treatment with multifortified bread for 120 days<br>|
| Active Comparator: FORTIFIED<br>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. | Other: FORTIFIED<br>* Treatment with standard bread, fortified according to current Peruvian guidelines for 120 days<br>|
| No Intervention: CONTROL<br>The control group will be followed for 120 days. No product will be provided. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Anemia | Percentage of volunteers reaching normal Hb levels during the study. | 120 days | 
| Hemoglobin levels | Variation in hemoglobin levels (mg/dL) | 120 days | 
| Serum ferritin levels | Variation in serum ferritin levels (ug/l) | 120 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hemoglobin levels | Variation in hemoglobin levels (mg/dL) | 90 days | 
| Serum ferritin levels | Variation in serum ferritin levels (ug/l) | 90 days | 
| Body iron content | Variation in body iron content levels | 120 days | 
| Mean corpuscular volume | Variation in mean corpuscular volume (fL) | 120 days | 
| Red Blood Cell Distribution Width | Variation in Red Blood Cell Distribution Width (%) | 120 days | 
| Soluble transferrin receptor levels | Variation in soluble transferrin receptor levels (nmol/L) | 120 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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iron deficiency anemia, hemoglobin, iron status, hematological parameters