An interventional study of MULTI-FORTIFIED and FORTIFIED in Iron Deficiency Anemia, sponsored by Universidad Peruana Cayetano Heredia. Status unknown at 1 site in Peru. Open to female participants aged 18 Years to 35 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2021-11-02.
Sponsored by Universidad Peruana Cayetano Heredia · Not applicable, Interventional, and Treatment
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.
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.
1,733 studies on the registry are indexed under Anemia; 246 are open to participants now.
This study's planned enrollment of 351 is above the median of 94 across 1,291 interventional studies indexed under Anemia.
Browse Anemia studies →Universidad Peruana Cayetano Heredia is the lead sponsor of 49 studies on the registry; 5 are open to participants now.
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Exclusion Criteria:
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.
Other: MULTI-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.
Other: FORTIFIED
The control group will be followed for 120 days. No product will be provided.
Treatment with multifortified bread for 120 days
Treatment with standard bread, fortified according to current Peruvian guidelines for 120 days
Anemia
Percentage of volunteers reaching normal Hb levels during the study.
Time frame: 120 days
Hemoglobin levels
Variation in hemoglobin levels (mg/dL)
Time frame: 120 days
Serum ferritin levels
Variation in serum ferritin levels (ug/l)
Time frame: 120 days
Hemoglobin levels
Variation in hemoglobin levels (mg/dL)
Time frame: 90 days
Serum ferritin levels
Variation in serum ferritin levels (ug/l)
Time frame: 90 days
Body iron content
Variation in body iron content levels
Time frame: 120 days
Mean corpuscular volume
Variation in mean corpuscular volume (fL)
Time frame: 120 days
Red Blood Cell Distribution Width
Variation in Red Blood Cell Distribution Width (%)
Time frame: 120 days
Soluble transferrin receptor levels
Variation in soluble transferrin receptor levels (nmol/L)
Time frame: 120 days
This study is status unknown, as verified in Jul 2021. You cannot join it, but the record below documents what was studied.
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Universidad Peruana Cayetano Heredia