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
About this trial
This is an interventional treatment trial for Anemia focused on measuring Infants, Prevalence, Iron, Deficiency, Treatment
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
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
NCT ID
NCT00655408
First Posted
April 3, 2008
Last Updated
April 3, 2008
Sponsor
Sao Jose do Rio Preto Medical School
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
Learn more about this trial
Iron-Deficiency Anemia in Infants in Two Weekly Programs
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