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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| MULTI-FORTIFIED | Experimental | 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 | Active Comparator | 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. |
|
| CONTROL | No Intervention | The control group will be followed for 120 days. No product will be provided. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MULTI-FORTIFIED | Other | Treatment with multifortified bread for 120 days |
| |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Hemoglobin levels | Variation in hemoglobin levels (mg/dL) | 90 days |
| Serum ferritin levels | Variation in serum ferritin levels (ug/l) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Dulce E Alarcon Yaquetto, MSc | Contact | +51 935401217 | dulce.alarcon@upch.pe |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centro de Salud Global | Recruiting | Tumbes | Peru |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32107773 | Background | Suchdev PS, Jefferds MED, Ota E, da Silva Lopes K, De-Regil LM. Home fortification of foods with multiple micronutrient powders for health and nutrition in children under two years of age. Cochrane Database Syst Rev. 2020 Feb 28;2(2):CD008959. doi: 10.1002/14651858.CD008959.pub3. | |
| 30673769 | Background | Eichler K, Hess S, Twerenbold C, Sabatier M, Meier F, Wieser S. Health effects of micronutrient fortified dairy products and cereal food for children and adolescents: A systematic review. PLoS One. 2019 Jan 23;14(1):e0210899. doi: 10.1371/journal.pone.0210899. eCollection 2019. |
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| ID | Term |
|---|---|
| D018798 | Anemia, Iron-Deficiency |
| ID | Term |
|---|---|
| D000747 | Anemia, Hypochromic |
| D000740 | Anemia |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
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| ID | Term |
|---|---|
| D005527 | Food, Fortified |
| ID | Term |
|---|---|
| D005502 | Food |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |
| D019602 | Food and Beverages |
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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.
| FORTIFIED |
| Other |
Treatment with standard bread, fortified according to current Peruvian guidelines for 120 days |
|
| 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 |
| 22760566 | Background | Gera T, Sachdev HS, Boy E. Effect of iron-fortified foods on hematologic and biological outcomes: systematic review of randomized controlled trials. Am J Clin Nutr. 2012 Aug;96(2):309-24. doi: 10.3945/ajcn.111.031500. Epub 2012 Jul 3. |
| 30759887 | Background | Finkelstein JL, Mehta S, Villalpando S, Mundo-Rosas V, Luna SV, Rahn M, Shamah-Levy T, Beebe SE, Haas JD. A Randomized Feeding Trial of Iron-Biofortified Beans on School Children in Mexico. Nutrients. 2019 Feb 12;11(2):381. doi: 10.3390/nu11020381. |
| 37963155 | Derived | Alarcon-Yaquetto DE, Rueda-Torres L, Bailon N, Barreto PV, Malaga G. Accuracy of HemoCue301 portable hemoglobin analyzer for anemia screening in capillary blood from women of reproductive age in a deprived region of Northern Peru: An on-field study. PLoS One. 2023 Nov 14;18(11):e0293984. doi: 10.1371/journal.pone.0293984. eCollection 2023. |
| D000090463 |
| Iron Deficiencies |
| D019189 | Iron Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |