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

August 5, 2011
April 10, 2012
October 2011
December 2011   (final data collection date for primary outcome measure)
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.
Same as current
Complete list of historical versions of study NCT01412723 on ClinicalTrials.gov Archive Site
  • 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.
  • 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: 4 times during 2 months (each 15 days) ] [ Designated as safety issue: No ]
    Telephone call every 15 days 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, heartburn, nausea, vomiting, constipation, diarrhea and darkening of feces.
Not Provided
Not Provided
 
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.

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Supportive Care
Iron Deficiency
  • Other: Ferrous sulfate as dietary supplementation
    Ferrous sulfate as dietary supplementation
  • Other: Iron amino acid chelated as dietary supplementation
    Iron amino acid chelated as dietary supplementation
  • 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
    Intervention: Other: 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
    Intervention: Other: Iron amino acid chelated as dietary supplementation
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
64
April 2012
December 2011   (final data collection date for primary outcome measure)

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
Both
2 Years to 5 Years
No
Contact information is only displayed when the study is recruiting subjects
Colombia
 
NCT01412723
SFHA-01
No
Jose María Maya Mejía, CES University
CES University
  • Nutreva S.A.S.
  • Fundación de Atención a la Niñez FAN
Study Director: Ana M Herrera, PhD en Patología CES University
CES University
April 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP