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Ferrous Sulfate Versus Iron Amino Acid Chelate

This study has been completed.
Sponsor:
Collaborators:
Nutreva S.A.S.
Fundación de Atención a la Niñez FAN
Information provided by (Responsible Party):
Jose María Maya Mejía, CES University
ClinicalTrials.gov Identifier:
NCT01412723
First received: August 5, 2011
Last updated: April 10, 2012
Last verified: April 2012
History of Changes
  Purpose

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.


Condition Intervention Phase
Iron Deficiency
 Other: Ferrous sulfate as dietary supplementation
Other: Iron amino acid chelated as dietary supplementation
 Phase 3

Study Type: Interventional
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
Official Title: EFICACIA DEL HIERRO AMINOQUELADO COMPARADO CON EL SULFATO FERROSO COMO COMPLEMENTO ALIMENTARIO EN PREESCOLARES CON DEFICIENCIA DE HIERRO.

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by CES University:

Primary Outcome Measures:
  • Ferritin [ Time Frame: Up to 8 weeks ] [ Designated as safety issue: No ]
    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 Outcome Measures:
  • Hemoglobin [ Time Frame: Up to 8 weeks ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    Daily written report of the caregiver during the intervention

  • Adverse reaction [ Time Frame: Daily. During 2 months of intervention ] [ Designated as safety issue: Yes ]
    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.


Enrollment: 64
Study Start Date: October 2011
Study Completion Date: April 2012
Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   2 Years to 5 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01412723

Locations
Colombia
Universidad CES
Medellin, Antioquia, Colombia
Sponsors and Collaborators
CES University
Nutreva S.A.S.
Fundación de Atención a la Niñez FAN
Investigators
Study Director: Ana M Herrera, PhD en Patología CES University
  More Information

No publications provided

Responsible Party: Jose María Maya Mejía, Dean, CES University
ClinicalTrials.gov Identifier: NCT01412723     History of Changes
Other Study ID Numbers: SFHA-01
Study First Received: August 5, 2011
Last Updated: April 10, 2012
Health Authority: Colombia: INVIMA Instituto Nacional de Vigilancia de Medicamentos y Alimentos

Keywords provided by CES University:
Iron Deficiency
Child, Preschool
Dietary Iron
Ferrous sulfate
Bis-glycino iron II

Additional relevant MeSH terms:
Anemia, Iron-Deficiency
Anemia, Hypochromic
Anemia
Hematologic Diseases
Iron Metabolism Disorders
Metabolic Diseases
 Iron
Trace Elements
Micronutrients
Growth Substances
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 21, 2013