Iron Deficiency
Conditions
Keywords
Iron Deficiency, Child, Preschool, Dietary Iron, Ferrous sulfate, Bis-glycino iron II
Brief summary
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.
Interventions
OTHERFerrous sulfate as dietary supplementation
Ferrous sulfate as dietary supplementation
OTHERIron amino acid chelated as dietary supplementation
Iron amino acid chelated as dietary supplementation
Sponsors
Nutreva S.A.S.
Foundation Child Care - FAN
CES University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
2 Years to 5 Years
Healthy volunteers
No
Inclusion criteria
Children who * Belong to institute FAN in Medellín * Attend full time to institute FAN (eight hours) * Have 2 to 5 years inclusive * Submit depleted levels of iron (ferritin level equal to or less than 24 mg/L)
Exclusion criteria
Children who * Submit anemia (hemoglobin level equal to or less than 11 g/dL) * Have not stool analysis before intervention
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Ferritin | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Hemoglobin | 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 | Daily. During 2 months of intervention | Daily written report of the caregiver during the intervention |
| Adverse reaction | 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. |
Countries
Colombia
Outcome results
None listed