Iron Deficiency Anemia
Conditions
Keywords
iron deficiency anemia, hemoglobin, iron status, hematological parameters
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.
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.
Interventions
OTHERMULTI-FORTIFIED
Treatment with multifortified bread for 120 days
OTHERFORTIFIED
Treatment with standard bread, fortified according to current Peruvian guidelines for 120 days
Sponsors
Universidad Peruana Cayetano Heredia
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Masking description
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.
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 35 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Anemia | 120 days | Percentage of volunteers reaching normal Hb levels during the study. |
| Hemoglobin levels | 120 days | Variation in hemoglobin levels (mg/dL) |
| Serum ferritin levels | 120 days | Variation in serum ferritin levels (ug/l) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Hemoglobin levels | 90 days | Variation in hemoglobin levels (mg/dL) |
| Body iron content | 120 days | Variation in body iron content levels |
| Soluble transferrin receptor levels | 120 days | Variation in soluble transferrin receptor levels (nmol/L) |
| Serum ferritin levels | 90 days | Variation in serum ferritin levels (ug/l) |
| Mean corpuscular volume | 120 days | Variation in mean corpuscular volume (fL) |
| Red Blood Cell Distribution Width | 120 days | Variation in Red Blood Cell Distribution Width (%) |
Countries
Peru
Contacts
Primary ContactDulce E Alarcon Yaquetto, MSc
Outcome results
None listed