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

Universidad Peruana Cayetano Heredia

Status: Unknown

Conditions: Iron Deficiency Anemia

Treatments: Other: FORTIFIED; Other: MULTI-FORTIFIED

Study type: Interventional

Funder types: Other

Identifiers

NCT05103709

SIDISI 204220

Details and patient eligibility

About

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.

Full 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.

Enrollment: 351 estimated patients

Sex: Female

Ages: 18 to 35 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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351 participants in 3 patient groups

MULTI-FORTIFIED

Experimental group

Description:

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.

Treatment:

Other: MULTI-FORTIFIED

FORTIFIED

Active Comparator group

Description:

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.

Treatment:

Other: FORTIFIED

CONTROL

No Intervention group

Description:

The control group will be followed for 120 days. No product will be provided.