Ferrous Sulfate Versus Iron Amino Acid Chelate

Iron Deficiency Clinical Trial

Official title:

EFICACIA DEL HIERRO AMINOQUELADO COMPARADO CON EL SULFATO FERROSO COMO COMPLEMENTO ALIMENTARIO EN PREESCOLARES CON DEFICIENCIA DE HIERRO.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01412723
• Other study ID #: SFHA-01
• Status: Completed
• Phase: Phase 3
• First received: August 5, 2011
• Last updated: April 10, 2012
• Start date: October 2011
• Est. completion date: April 2012

Study information

• Verified date: April 2012
• Source: CES University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Colombia: INVIMA Instituto Nacional de Vigilancia de Medicamentos y Alimentos
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 64
• Est. completion date: April 2012
• Est. primary completion date: December 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 2 Years to 5 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Anemia, Iron-Deficiency
• Iron Deficiency

Intervention

Other:
• Ferrous sulfate as dietary supplementation
Ferrous sulfate as dietary supplementation
• Iron amino acid chelated as dietary supplementation
Iron amino acid chelated as dietary supplementation

Locations

Country	Name	City	State
Colombia	Universidad CES	Medellin	Antioquia

Sponsors (3)

Lead Sponsor	Collaborator
CES University	Fundación de Atención a la Niñez FAN, Nutreva S.A.S.

Country where clinical trial is conducted

Colombia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Up to 8 weeks	No
Secondary	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	Up to 8 weeks	No
Secondary	Infection	Daily written report of the caregiver during the intervention	Daily. During 2 months of intervention	No
Secondary	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.	Daily. During 2 months of intervention	Yes