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

Iron Deficiency Anemia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05103709
• Other study ID #: SIDISI 204220
• Status: Recruiting
• Phase: N/A
• Start date: August 3, 2021
• Est. completion date: February 2022

Study information

• Verified date: July 2021
• Source: Universidad Peruana Cayetano Heredia
• Contact: Dulce E Alarcon Yaquetto, MSc
• Phone: +51 935401217
• Email: dulce.alarcon[@]upch.pe
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Recruiting
• Enrollment: 351
• Est. completion date: February 2022
• Est. primary completion date: January 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 35 Years

Eligibility

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.

Related Conditions & MeSH terms

• Anemia
• Anemia, Iron-Deficiency
• Deficiency Diseases
• Iron Deficiency Anemia

Intervention

Other:
• MULTI-FORTIFIED
Treatment with multifortified bread for 120 days
• FORTIFIED
Treatment with standard bread, fortified according to current Peruvian guidelines for 120 days

Locations

Country	Name	City	State
Peru	Centro de Salud Global	Tumbes

Sponsors (1)

Lead Sponsor	Collaborator
Universidad Peruana Cayetano Heredia

Country where clinical trial is conducted

Peru, 

References & Publications (4)

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. — View Citation

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). pii: E381. doi: 10.3390/nu11020381. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Anemia	Percentage of volunteers reaching normal Hb levels during the study.	120 days
Primary	Hemoglobin levels	Variation in hemoglobin levels (mg/dL)	120 days
Primary	Serum ferritin levels	Variation in serum ferritin levels (ug/l)	120 days
Secondary	Hemoglobin levels	Variation in hemoglobin levels (mg/dL)	90 days
Secondary	Serum ferritin levels	Variation in serum ferritin levels (ug/l)	90 days
Secondary	Body iron content	Variation in body iron content levels	120 days
Secondary	Mean corpuscular volume	Variation in mean corpuscular volume (fL)	120 days
Secondary	Red Blood Cell Distribution Width	Variation in Red Blood Cell Distribution Width (%)	120 days
Secondary	Soluble transferrin receptor levels	Variation in soluble transferrin receptor levels (nmol/L)	120 days