Effect of Multiple Micronutrient Fortified Bread Consumption on Iron Deficiency Anemia in Women of Reproductive Age
NCT ID: NCT05103709
Last Updated: 2021-11-02
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
UNKNOWN
NA
351 participants
INTERVENTIONAL
2021-08-03
2022-02-28
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Keywords
Explore important study keywords that can help with search, categorization, and topic discovery.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
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.
MULTI-FORTIFIED
Treatment with multifortified bread for 120 days
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.
FORTIFIED
Treatment with standard bread, fortified according to current Peruvian guidelines for 120 days
CONTROL
The control group will be followed for 120 days. No product will be provided.
No interventions assigned to this group
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
MULTI-FORTIFIED
Treatment with multifortified bread for 120 days
FORTIFIED
Treatment with standard bread, fortified according to current Peruvian guidelines for 120 days
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
* 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.
18 Years
35 Years
FEMALE
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Universidad Peruana Cayetano Heredia
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Centro de Salud Global
Tumbes, , Peru
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Percy M Vílchez-Barreto, BSc
Role: primary
References
Explore related publications, articles, or registry entries linked to this study.
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.
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.
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.
Alarcon-Yaquetto DE, Rueda-Torres L, Bailon N, Barreto PV, Malaga G. Accuracy of HemoCue301 portable hemoglobin analyzer for anemia screening in capillary blood from women of reproductive age in a deprived region of Northern Peru: An on-field study. PLoS One. 2023 Nov 14;18(11):e0293984. doi: 10.1371/journal.pone.0293984. eCollection 2023.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
SIDISI 204220
Identifier Type: -
Identifier Source: org_study_id