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

This study has been completed.
Sponsor:
Information provided by:
Sao Jose do Rio Preto University
ClinicalTrials.gov Identifier:
NCT00655408
First received: April 3, 2008
Last updated: NA
Last verified: April 2008
History: No changes posted
  Purpose

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 Intervention
Anemia
Drug: elemental iron

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: Iron-Deficiency Anemia in Infants: Comparative Study of Two Weekly Supplement Programs

Resource links provided by NLM:


Further study details as provided by Sao Jose do Rio Preto University:

Primary Outcome Measures:
  • Test (serum hemoglobin) [ Time Frame: assessed at the before of the treatment period ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Test (serum hemoglobin) [ Time Frame: assessed after 12 weekly with iron supplement ] [ Designated as safety issue: Yes ]

Enrollment: 130
Study Start Date: April 2003
Study Completion Date: January 2004
Primary Completion Date: September 2003 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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).

  Eligibility

Ages Eligible for Study:   6 Months to 24 Months
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00655408

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

No publications provided by Sao Jose do Rio Preto University

Additional 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
Study First Received: April 3, 2008
Last Updated: April 3, 2008
Health Authority: Brazil: Ministry of Health

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

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

ClinicalTrials.gov processed this record on September 11, 2014