Effect of Multiple Micronutrient Fortified Bread Consumption on Iron Deficiency Anemia in Women of Reproductive Age
1 other identifier
interventional
351
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Aug 2021
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 3, 2021
CompletedFirst Submitted
Initial submission to the registry
October 25, 2021
CompletedFirst Posted
Study publicly available on registry
November 2, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2022
CompletedNovember 2, 2021
July 1, 2021
5 months
October 25, 2021
October 25, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
Anemia
Percentage of volunteers reaching normal Hb levels during the study.
120 days
Hemoglobin levels
Variation in hemoglobin levels (mg/dL)
120 days
Serum ferritin levels
Variation in serum ferritin levels (ug/l)
120 days
Secondary Outcomes (6)
Hemoglobin levels
90 days
Serum ferritin levels
90 days
Body iron content
120 days
Mean corpuscular volume
120 days
Red Blood Cell Distribution Width
120 days
- +1 more secondary outcomes
Study Arms (3)
MULTI-FORTIFIED
EXPERIMENTALThe 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.
FORTIFIED
ACTIVE COMPARATORThe 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.
CONTROL
NO INTERVENTIONThe control group will be followed for 120 days. No product will be provided.
Interventions
Treatment with standard bread, fortified according to current Peruvian guidelines for 120 days
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Centro de Salud Global
Tumbes, Peru
Related Publications (5)
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.
PMID: 32107773BACKGROUNDEichler 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.
PMID: 30673769BACKGROUNDGera 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.
PMID: 22760566BACKGROUNDFinkelstein 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.
PMID: 30759887BACKGROUNDAlarcon-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.
PMID: 37963155DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Masking Details
- Masking will be mixed. Since the third arm will not receive product of any kind it is not possible to mask the volunteers assigned to this group. The packaging of the products will be neutral to blind the volunteers in the groups that will receive products. The investigators will be blinded to randomization at all times.
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 25, 2021
First Posted
November 2, 2021
Study Start
August 3, 2021
Primary Completion
January 1, 2022
Study Completion
February 1, 2022
Last Updated
November 2, 2021
Record last verified: 2021-07