AnemiaIDANCT00655408
Iron-Deficiency Anemia in Infants in Two Weekly Programs
A study testing elemental iron in people with Anemia, run by Sao Jose do Rio Preto Medical School.
Trial 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. Read more about this study
- Who is it for?
- Ages 6 to 24 monthsHealthy volunteers can take part
- Conditions the study is for
- Anemia
- What is being tested?
- elemental iron
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 130 participants
- Where
- No sites listed yet
- Study dates
- Apr 2003to Jan 2004
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 24 months
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Ages ranging between six and 24 months old
Who cannot join
- Positive results for the Guthrie test
- Use of ferrous sulfate supplements
- Infections process at the time of first consultation
About this study
Official title: Iron-Deficiency Anemia in Infants: Comparative Study of Two Weekly Supplement Programs
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.
Read the 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).
- Conditions
- Anemia
- Being tested
- elemental iron
- Keywords
- Infants, Prevalence, Iron, Deficiency, Treatment
- Medical subject headings
- Anemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
elemental ironDrug
Also called doses of 25 mg of elemental iron
Iron supplementation.
| Study group | Role | What they receive |
|---|---|---|
| A | Active comparator | 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. Receives: Drug: elemental iron |
What is being measured
The primary outcome is the main question the study is designed to answer.
Test (serum hemoglobin)
Measured: assessed at the before of the treatment period
Secondary outcomes (1)
Test (serum hemoglobin)
Measured: assessed after 12 weekly with iron supplement
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Apr 2008 (estimated)
- Study startApr 2003
- Primary completionSep 2003
- Study completionJan 2004
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for AnemiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 130 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sao Jose do Rio Preto Medical School
- Sponsor type
- University, hospital or other
- Investigators
- Coutinho Geraldo Gaspar Paes Leme, MD, Principal investigator, University Medical School f São Jose do Rio Preto-Brazil
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00655408
- Sponsor's protocol ID
- FAMERP-001
- Acronym
- IDA
- Status last verified
- Apr 2008
- First submitted
- 3 Apr 2008
- Last updated
- 9 Apr 2008
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 19274317
Study at a glance
From the registry record, last updated by the sponsor on 9 Apr 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Iron-Deficiency Anemia in Infants: Comparative Study of Two Weekly Supplement Programs
- ClinicalTrials.gov ID
- NCT00655408
- Acronym / sponsor ID
- IDA / FAMERP-001
- Conditions
- Anemia
- Keywords
- Infants, Prevalence, Iron, Deficiency, Treatment
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 130 participants (actual)
- Lead sponsor
- Sao Jose do Rio Preto Medical SchoolUniversity, hospital or other
- Study start
- Apr 2003
- Primary completion
- Sep 2003 (actual)
- Study completion
- Jan 2004 (actual)
- First posted
- 9 Apr 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| A | Active comparator | Drug: elemental ironFor 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. |
Who may qualify
- Ages
- 6 to 24 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Ages ranging between six and 24 months old
Key exclusion criteria (3 listed)
- Positive results for the Guthrie test
- Use of ferrous sulfate supplements
- Infections process at the time of first consultation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| elemental ironAlso: doses of 25 mg of elemental ironIron supplementation. | Drug | A |
Primary outcome
Test (serum hemoglobin)
Time frame: assessed at the before of the treatment period
1 secondary outcome
Test (serum hemoglobin)
Time frame: assessed after 12 weekly with iron supplement
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Apr 2008.
- Derived from this study: PubMed 19274317Coutinho 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.
Related trials for Anemia
RecruitingPhase 2
Study to Assess the Safety and Tolerability of Tafasitamab in Adult Participants With Primary Autoimmune Blood Cell Disorders
Immune Thrombocytopenia
RecruitingObservational study
A Long-term Follow-up Study of Patients With ARD103 CAR-T Cell Therapies
Acute Myeloid Leukemia, in Relapse, Acute Myeloid Leukemia, in Relapsed or Refractory
Active, not recruitingPhase 3
A Study Evaluating the Efficacy, Safety, Pharmacokinetics and Pharmacodynamics of Crovalimab in Adult and Adolescent Participants With Atypical Hemolytic Uremic Syndrome (aHUS)
Atypical Hemolytic Uremic Syndrome
RecruitingPhase 1/2
Pacritinib, a Kinase Inhibitor of CSF1R, IRAK1, JAK2, and FLT3, in Adults and Pediatric Participants 12 Years of Age or Older With Myelodysplastic Syndromes or Myelodysplastic/Myeloproliferative Neoplasms
Myelodysplastic Syndromes
Not yet recruitingObservational study
Clinical Genetics Branch Eligibility Screening Survey
Melanoma, Li-Fraumeni Syndrome
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Coutinho Geraldo Gaspar Paes Leme, MD principal investigator
University Medical School f São Jose do Rio Preto-Brazil
Questions about this trial
What is this clinical trial studying?
A study testing elemental iron in people with Anemia, run by Sao Jose do Rio Preto Medical School.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Apr 2008. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Test (serum hemoglobin) (time frame: assessed at the before of the treatment period). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00655408, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Apr 2008.