Ferrous Sulfate Versus Iron Amino Acid Chelate
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.
|Iron Deficiency||Other: Ferrous sulfate as dietary supplementation Other: Iron amino acid chelated as dietary supplementation||Phase 3|
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Supportive Care
|Official Title:||EFICACIA DEL HIERRO AMINOQUELADO COMPARADO CON EL SULFATO FERROSO COMO COMPLEMENTO ALIMENTARIO EN PREESCOLARES CON DEFICIENCIA DE HIERRO.|
- Ferritin [ Time Frame: Up to 8 weeks ]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.
- Hemoglobin [ Time Frame: Up to 8 weeks ]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
- Infection [ Time Frame: Daily. During 2 months of intervention ]Daily written report of the caregiver during the intervention
- Adverse reaction [ Time Frame: Daily. During 2 months of intervention ]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.
|Study Start Date:||October 2011|
|Study Completion Date:||April 2012|
|Primary Completion Date:||December 2011 (Final data collection date for primary outcome measure)|
Active Comparator: Ferrous sulphate
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
Ferrous sulfate as dietary supplementation
Experimental: Iron Amino acid chelate
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
Iron amino acid chelated as dietary supplementation
Please refer to this study by its ClinicalTrials.gov identifier: NCT01412723
|Medellin, Antioquia, Colombia|
|Study Director:||Ana M Herrera, PhD en Patología||CES University|