Iron Deficiency AnemiaNCT05103709
Effect of Multiple Micronutrient Fortified Bread Consumption on Iron Deficiency Anemia in Women of Reproductive Age
A study testing MULTI-FORTIFIED and FORTIFIED in people with Iron Deficiency Anemia, run by Universidad Peruana Cayetano Heredia at 1 site in Peru.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 35 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Iron Deficiency Anemia
- What is being tested?
- MULTI-FORTIFIED and FORTIFIED
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 351 participants
- Where
- 1 sitePeru
- Study dates
- 3 Aug 2021to Feb 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 35 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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,
Show all 9Show fewer
- Smoking,
- Inability to sign informed consent,
- Consumption of nutritional supplements.
Trial locations and contacts
1 site in 1 country.
Peru1 site, 1 recruiting
- Recruiting
Centro de Salud Global
Tumbes
Percy M Vílchez-Barreto, BSc, +51 72-782037, percy.vilchez.b@upch.pe
About this study
Official title: Effect of Multiple Micronutrient Fortified Bread Consumption on Iron Deficiency Anemia in Women of Reproductive Age: A Randomized Controlled Trial
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.
Read the 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.
- Conditions
- Iron Deficiency Anemia
- Being tested
- MULTI-FORTIFIED, FORTIFIED
- Keywords
- iron deficiency anemia, hemoglobin, iron status, hematological parameters
- Medical subject headings
- Anemia, Iron-Deficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MULTI-FORTIFIEDOther
Treatment with multifortified bread for 120 days
FORTIFIEDOther
Treatment with standard bread, fortified according to current Peruvian guidelines for 120 days
| Study group | Role | What they receive |
|---|---|---|
| MULTI-FORTIFIED | Experimental | 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. Receives: Other: MULTI-FORTIFIED |
| FORTIFIED | Active comparator | 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. Receives: Other: FORTIFIED |
| CONTROL | No intervention | The control group will be followed for 120 days. No product will be provided. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Anemia
Percentage of volunteers reaching normal Hb levels during the study.
Measured: 120 days
Hemoglobin levels
Variation in hemoglobin levels (mg/dL)
Measured: 120 days
Serum ferritin levels
Variation in serum ferritin levels (ug/l)
Measured: 120 days
Secondary outcomes (6)
Hemoglobin levels
Variation in hemoglobin levels (mg/dL)
Measured: 90 days
Serum ferritin levels
Variation in serum ferritin levels (ug/l)
Measured: 90 days
Body iron content
Variation in body iron content levels
Measured: 120 days
Mean corpuscular volume
Variation in mean corpuscular volume (fL)
Measured: 120 days
Red Blood Cell Distribution Width
Variation in Red Blood Cell Distribution Width (%)
Measured: 120 days
Soluble transferrin receptor levels
Variation in soluble transferrin receptor levels (nmol/L)
Measured: 120 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Nov 2021
- Study start3 Aug 2021
- Primary completionJan 2022 (estimated)
- Study completionFeb 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Iron Deficiency AnemiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 351 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universidad Peruana Cayetano Heredia
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05103709
- Sponsor's protocol ID
- SIDISI 204220
- Status last verified
- Jul 2021
- First submitted
- 25 Oct 2021
- Last updated
- 2 Nov 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 32107773Eichler 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.
PubMed 30673769Gera 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.
PubMed 22760566Finkelstein 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.
PubMed 30759887Alarcon-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.
PubMed 37963155
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Multiple Micronutrient Fortified Bread Consumption on Iron Deficiency Anemia in Women of Reproductive Age: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05103709
- Acronym / sponsor ID
- SIDISI 204220
- Conditions
- Iron Deficiency Anemia
- Keywords
- iron deficiency anemia, hemoglobin, iron status, hematological parameters
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 351 participants (estimated)
- Lead sponsor
- Universidad Peruana Cayetano HerediaUniversity, hospital or other
- Study start
- 3 Aug 2021 (actual)
- Primary completion
- Jan 2022 (estimated)
- Study completion
- Feb 2022 (estimated)
- First posted
- 2 Nov 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| MULTI-FORTIFIED | Experimental | Other: MULTI-FORTIFIEDThe 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 comparator | Other: FORTIFIEDThe 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 intervention | –The control group will be followed for 120 days. No product will be provided. |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (9 listed)
- 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,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MULTI-FORTIFIEDTreatment with multifortified bread for 120 days | Other | MULTI-FORTIFIED |
| FORTIFIEDTreatment with standard bread, fortified according to current Peruvian guidelines for 120 days | Other | FORTIFIED |
Primary outcome
Anemia
Time frame: 120 days
Percentage of volunteers reaching normal Hb levels during the study.
Hemoglobin levels
Time frame: 120 days
Variation in hemoglobin levels (mg/dL)
Serum ferritin levels
Time frame: 120 days
Variation in serum ferritin levels (ug/l)
6 secondary outcomes
Hemoglobin levels
Time frame: 90 days
Serum ferritin levels
Time frame: 90 days
Body iron content
Time frame: 120 days
Mean corpuscular volume
Time frame: 120 days
Red Blood Cell Distribution Width
Time frame: 120 days
Soluble transferrin receptor levels
Time frame: 120 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Nov 2021.
- Background: PubMed 32107773Suchdev 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.
- Background: PubMed 30673769Eichler 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.
- Background: PubMed 22760566Gera 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.
- Background: PubMed 30759887Finkelstein 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.
- Derived from this study: PubMed 37963155Alarcon-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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MULTI-FORTIFIED and FORTIFIED in people with Iron Deficiency Anemia, run by Universidad Peruana Cayetano Heredia at 1 site in Peru.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 2 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Peru. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Dulce E Alarcon Yaquetto, MSc (+51 935401217, dulce.alarcon@upch.pe), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Anemia (time frame: 120 days). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05103709, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Nov 2021.