UnknownNot Applicable

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

Peru351 participantsStarted 2021-08-03

Plain-language 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.

Who can participate

Age range

18 Years – 35 Years

Sex

FEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Anemia

Timeframe: 120 days

Hemoglobin levels

Timeframe: 120 days

Serum ferritin levels

Timeframe: 120 days

Trial details

NCT IDNCT05103709

SponsorUniversidad Peruana Cayetano Heredia

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2022-01

Contact for this trial

Dulce E Alarcon Yaquetto, MSc

+51 935401217 dulce.alarcon@upch.pe

View on ClinicalTrials.gov More Iron Deficiency Anemia trials

Who can participate

Age range

18 Years – 35 Years

Sex

FEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.