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

Primary Purpose

Anemia

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
elemental iron
Sponsored by
Sao Jose do Rio Preto Medical School
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Anemia focused on measuring Infants, Prevalence, Iron, Deficiency, Treatment

Eligibility Criteria

6 Months - 24 Months (Child)All SexesAccepts Healthy Volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Active Comparator

    Arm Label

    A

    Arm Description

    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.

    Outcomes

    Primary Outcome Measures

    Test (serum hemoglobin)

    Secondary Outcome Measures

    Test (serum hemoglobin)

    Full Information

    First Posted
    April 3, 2008
    Last Updated
    April 3, 2008
    Sponsor
    Sao Jose do Rio Preto Medical School
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00655408
    Brief Title
    Iron-Deficiency Anemia in Infants in Two Weekly Programs
    Acronym
    IDA
    Official Title
    Iron-Deficiency Anemia in Infants: Comparative Study of Two Weekly Supplement Programs
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    April 2008
    Overall Recruitment Status
    Completed
    Study Start Date
    April 2003 (undefined)
    Primary Completion Date
    September 2003 (Actual)
    Study Completion Date
    January 2004 (Actual)

    3. Sponsor/Collaborators

    Name of the Sponsor
    Sao Jose do Rio Preto Medical School

    4. Oversight

    Data Monitoring Committee
    No

    5. 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.
    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).

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Anemia
    Keywords
    Infants, Prevalence, Iron, Deficiency, Treatment

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    Participant
    Allocation
    Randomized
    Enrollment
    130 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    A
    Arm Type
    Active Comparator
    Arm Description
    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.
    Intervention Type
    Drug
    Intervention Name(s)
    elemental iron
    Other Intervention Name(s)
    doses of 25 mg of elemental iron
    Intervention Description
    Iron supplementation.
    Primary Outcome Measure Information:
    Title
    Test (serum hemoglobin)
    Time Frame
    assessed at the before of the treatment period
    Secondary Outcome Measure Information:
    Title
    Test (serum hemoglobin)
    Time Frame
    assessed after 12 weekly with iron supplement

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    6 Months
    Maximum Age & Unit of Time
    24 Months
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility 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
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Coutinho Geraldo Gaspar Paes Leme, MD
    Organizational Affiliation
    University Medical School f São Jose do Rio Preto-Brazil
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    19274317
    Citation
    Coutinho GG, Goloni-Bertollo EM, Pavarino-Bertelli EC. Effectiveness of two programs of intermittent ferrous supplementation for treating iron-deficiency anemia in infants: randomized clinical trial. Sao Paulo Med J. 2008 Nov;126(6):314-8. doi: 10.1590/s1516-31802008000600004.
    Results Reference
    derived

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    Iron-Deficiency Anemia in Infants in Two Weekly Programs

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