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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Iron Deficiency Anemia
• Intervention / Treatment: Other: MULTI-FORTIFIED; Other: FORTIFIED

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.

• Study Type: Interventional
• Enrollment (Anticipated): 351
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Dulce E Alarcon Yaquetto, MSc; Phone Number: +51 935401217; Email: dulce.alarcon@upch.pe

Study Locations

• Peru
  • Tumbes, Peru
    • Recruiting
    • Centro de Salud Global
    • Contact: Percy M Vílchez-Barreto, BSc; Phone Number: +51 72-782037; Email: percy.vilchez.b@upch.pe

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 35 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

3

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Universidad Peruana Cayetano Heredia

Publications and helpful links

General Publications

• 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:CD008959. doi: 10.1002/14651858.CD008959.pub3.
• 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.
• 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. Review.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): August 3, 2021
• Primary Completion (Anticipated): January 1, 2022
• Study Completion (Anticipated): February 1, 2022

Study Registration Dates

• First Submitted: October 25, 2021
• First Submitted That Met QC Criteria: October 25, 2021
• First Posted (Actual): November 2, 2021

Study Record Updates

• Last Update Posted (Actual): November 2, 2021
• Last Update Submitted That Met QC Criteria: October 25, 2021
• Last Verified: July 1, 2021

More Information

Terms related to this study

• Keywords: hemoglobin; iron deficiency anemia; hematological parameters; iron status
• Additional Relevant MeSH Terms: Metabolic Diseases; Hematologic Diseases; Nutrition Disorders; Anemia, Hypochromic; Iron Metabolism Disorders; Malnutrition; Anemia, Iron-Deficiency; Anemia; Deficiency Diseases
• Other Study ID Numbers: SIDISI 204220

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No