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Completed

NCT Number: NCT01412723

Ferrous Sulfate Versus Iron Amino Acid Chelate

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.

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Key information

Conditions

Iron Deficiency Iron Deficiencies Iron Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

2 year–5 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Universidad CES

Medellín, Antioquia, Colombia

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Ferrous sulfate as dietary supplementation

Other

Ferrous sulfate as dietary supplementation

Iron amino acid chelated as dietary supplementation

Other

Iron amino acid chelated as dietary supplementation

Primary outcomes

  1. Ferritin

    Time frame: 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 outcomes

  1. Hemoglobin

    Time frame: 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

  2. Infection

    Time frame: Daily. During 2 months of intervention

    Daily written report of the caregiver during the intervention

  3. Adverse reaction

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

CES University

Other

Collaborators

  • Foundation Child Care - FAN
  • Nutreva S.A.S.

Registry information

Official study title

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

Important dates

Study start
2011
Primary completion
2011
Study completion
2012
First posted
Aug 9, 2011
Registry last updated
Apr 11, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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