Clinical trial NCT05103709: Effect of Multiple Micronutrient Fortified Bread Consumption on Iron Deficiency Anemia in Women of Reproductive Age
Official title: Effect of Multiple Micronutrient Fortified Bread Consumption on Iron Deficiency Anemia in Women of Reproductive Age: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Iron Deficiency Anemia
Keywords: iron deficiency anemia
hemoglobin
iron status
hematological parameters
Lead sponsor: Universidad Peruana Cayetano Heredia
Sponsor class: OTHER
First posted: 2021-11-02
Enrollment: 351
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Anemia
timeFrame: 120 days
measure: Hemoglobin levels
timeFrame: 120 days
measure: Serum ferritin levels
timeFrame: 120 days
Secondary outcomes:
measure: Hemoglobin levels
timeFrame: 90 days
measure: Serum ferritin levels
timeFrame: 90 days
measure: Body iron content
timeFrame: 120 days
measure: Mean corpuscular volume
timeFrame: 120 days
measure: Red Blood Cell Distribution Width
timeFrame: 120 days
measure: Soluble transferrin receptor levels
timeFrame: 120 days
Other outcomes:
Locations:
city: Tumbes
country: Peru
facility: Centro de Salud Global
Study officials:
References:
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(2):CD008959. doi: 10.1002/14651858.CD008959.pub3.
citation: 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.
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.
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):381. doi: 10.3390/nu11020381.