A Phase 3 interventional study of Ferrous sulfate as dietary supplementation and Iron amino acid chelated as dietary supplementation in Iron Deficiency, sponsored by CES University. Completed at 1 site in Colombia. Open to participants aged 2 Years to 5 Years. Per ClinicalTrials.gov, last updated 2012-04-11.
Sponsored by CES University · Phase 3, Interventional, and Supportive care
Iron deficiency and depleted levels of iron are the most prevalent nutritional deficiency and the leading cause of anemia in the world; this can occur at any age, but preschool children are at particular risk of developing it. This condition may cause serious repercussions for life, being a public health threat of considerable importance worldwide.
Food fortification is considered the most effective solution to counter this situation, because it can help more people than other solutions. It is going to carry out a community trial to compare the efficacy of ferrous sulfate with respect to iron amino acid chelate as a dietary supplement in preschool children of Medellin with depleted levels of iron; in terms of increasing ferritin levels in blood and maintain hemoglobin levels. It is hypothesized that at the end of the study the effect of milk fortified with iron amino acid chelate won't be less than the effect of fortified with ferrous sulfate.
It is hoped that the results may contribute, albeit indirectly, to improve the health status of children with depleted levels of iron whom consume iron-fortified products.
644 studies on the registry are indexed under Anemia, Iron-Deficiency; 105 are open to participants now.
This study's enrollment of 64 is below the median of 100 across 503 interventional studies indexed under Anemia, Iron-Deficiency.
Browse Anemia, Iron-Deficiency studies →CES University is the lead sponsor of 28 studies on the registry; 2 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Children who
Exclusion Criteria:
Children who
Preschool children with depleted levels of iron enrolled in FAN Foundation of Medellin, which will be supplied with ferrous sulfate-fortified milk
Other: Ferrous sulfate as dietary supplementation
Preschool children with depleted levels of iron enrolled in FAN Foundation of Medellin , which will be supplied with iron amino acid chelate-fortified milk
Other: Iron amino acid chelated as dietary supplementation
Ferrous sulfate as dietary supplementation
Iron amino acid chelated as dietary supplementation
Ferritin
The Ferritin level in blood will be measured at the beginning of the study as one of the most important inclusion criteria. This also will be the base line of the study. After that randomization will be carried out and after two months (time frame which ferrous sulfate or iron aminoacid chelate would increase ferritin level in blood) ferritin level will be measured again as the primary outcome measure.
Time frame: Up to 8 weeks
Hemoglobin
The Hemoglobin level in blood will be measured at the beginning of the study as one of the most important exclusion criteria. After that randomization will be carried out and after two months (time frame which ferrous sulfate or iron aminoacid chelate would increase ferritin level in blood) hemoglobin level will be measured again as one of secundary outcome measure. The hypothesis is that the hemoglobin level won't decrease
Time frame: Up to 8 weeks
Infection
Daily written report of the caregiver during the intervention
Time frame: Daily. During 2 months of intervention
Adverse reaction
The caregiver recorded daily if the child had an adverse reaction such as abdominal pain, nausea, vomiting, constipation, diarrhea, darkening of feces, and disgust for food.
Time frame: Daily. During 2 months of intervention
This study is completed, as verified in Apr 2012. You cannot join it, but the record below documents what was studied.
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CES University