Ferrous Sulfate Versus Iron Amino Acid Chelate

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

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.

Study Overview

• Status: Completed
• Conditions: Iron Deficiency
• Intervention / Treatment: Other: Ferrous sulfate as dietary supplementation; Other: Iron amino acid chelated as dietary supplementation

• Study Type: Interventional
• Enrollment (Actual): 64
• Phase: Phase 3

Contacts and Locations

Study Locations

• Colombia
  • Antioquia
    • Medellin, Antioquia, Colombia
      • Universidad CES

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 8 months to 3 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
Infection	Daily written report of the caregiver during the intervention	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.	Daily. During 2 months of intervention

Collaborators and Investigators

• Sponsor: CES University
• Collaborators: Nutreva S.A.S.; Foundation Child Care - FAN
• Investigators: Study Director: Ana M Herrera, PhD en Patología, CES University

Study record dates

Study Major Dates

• Study Start: October 1, 2011
• Primary Completion (Actual): December 1, 2011
• Study Completion (Actual): April 1, 2012

Study Registration Dates

• First Submitted: August 5, 2011
• First Submitted That Met QC Criteria: August 8, 2011
• First Posted (Estimate): August 9, 2011

Study Record Updates

• Last Update Posted (Estimate): April 11, 2012
• Last Update Submitted That Met QC Criteria: April 10, 2012
• Last Verified: April 1, 2012

More Information

Terms related to this study

• Keywords: Iron Deficiency; Child, Preschool; Ferrous sulfate; Dietary Iron; Bis-glycino iron II
• Additional Relevant MeSH Terms: Metabolic Diseases; Hematologic Diseases; Anemia, Hypochromic; Anemia; Iron Metabolism Disorders; Anemia, Iron-Deficiency
• Other Study ID Numbers: SFHA-01