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Iron-Deficiency Anemia in Infants in Two Weekly Programs (IDA)

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ClinicalTrials.gov Identifier: NCT00655408
Recruitment Status : Completed
First Posted : April 9, 2008
Last Update Posted : April 9, 2008
Sponsor:
Information provided by:

Study Description
Brief Summary:
This work aims at establishing the effectiveness of weekly doses of ferrous sulfate administered by mothers compared with weekly supplements administered directly by healthcare professionals, to reducing anemia prevalence.

Condition or disease Intervention/treatment
Anemia Drug: elemental iron

Detailed Description:

Some studies have shown satisfactory results in reducing the prevalence of iron deficiency using weekly doses of ferrous sulfate, thereby avoiding these side effects. This deficiency is the most common nutritional disorder during childhood and does not only affect individuals from developing countries but also those from industrialized nations.

For infants with ages between six and 24 months, iron supplementation is the main treatment for iron deficiency. In this age range the prevalence of anemia is at least 20%. However, studies have shown a low rate of compliance by mothers during the recommended period, which may be caused by a lack of care or, more probably, due to the side effects caused by long-term daily ferrous sulfate supplementation, which include nausea, vomiting, diarrhea, staining of teeth and abdominal pain.

This specific study is randomized clinical trial study, achieved in a government healthcare clinic in Sao Jose do Rio Preto, Sao Paulo, Brazil. This study was carried out using two intervention groups. All children received 12 weekly doses of 25 mg of elemental iron, either administered in the government healthcare clinic or at the children's home.

The study showed treatment compliance in both groups. Prevalence of anemia for all children was 75% at the beginning of supplementation and 46.3% at the end of the period (p < 0.0005). Reduction rate for anemic children was 38.3%. Average increases in hemoglobin concentration levels were 0.75 g/dL and 0.65 g/dL, respectively, for home interventions and healthcare clinic administration (p < 0.00005).


Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 130 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Iron-Deficiency Anemia in Infants: Comparative Study of Two Weekly Supplement Programs
Study Start Date : April 2003
Primary Completion Date : September 2003
Study Completion Date : January 2004

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anemia Iron
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Active Comparator: A

For infants with ages between six and 24 months, iron supplementation is the main treatment for iron deficiency.This study was carried out using two intervention groups. All children received 12 weekly doses of 25 mg of elemental iron.

Group 1 administered in the government healthcare clinic. Group 2 administered children's home.

The study showed treatment compliance in both groups.

Drug: elemental iron
Iron supplementation.
Other Name: doses of 25 mg of elemental iron


Outcome Measures

Primary Outcome Measures :
  1. Test (serum hemoglobin) [ Time Frame: assessed at the before of the treatment period ]

Secondary Outcome Measures :
  1. Test (serum hemoglobin) [ Time Frame: assessed after 12 weekly with iron supplement ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   6 Months to 24 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Ages ranging between six and 24 months old

Exclusion Criteria:

  • Positive results for the Guthrie test
  • Use of ferrous sulfate supplements
  • Infections process at the time of first consultation
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00655408


Sponsors and Collaborators
Sao Jose do Rio Preto Medical School
Investigators
Principal Investigator: Coutinho Geraldo Gaspar Paes Leme, MD University Medical School f São Jose do Rio Preto-Brazil
More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Sao Jose do Rio Preto Medical School
ClinicalTrials.gov Identifier: NCT00655408     History of Changes
Other Study ID Numbers: FAMERP-001
First Posted: April 9, 2008    Key Record Dates
Last Update Posted: April 9, 2008
Last Verified: April 2008

Keywords provided by Sao Jose do Rio Preto Medical School:
Infants
Prevalence
Iron
Deficiency
Treatment

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