MalariaNCT00497471
RCT Iron Supplementation and Malaria Chemoprophylaxis for Prevention of Severe Anemia and Malaria in Tanzanian Infants
A study testing Deltaprim (3.125 mg pyrimethamine plus 25 mg dapsone) and iron (2 mg/kg/daily) in people with Malaria and Anemia, run by Hospital Clinic of Barcelona at 1 site in Tanzania.
Trial summary
The purpose of this trial is to evaluate the efficacy of weekly iron supplementation and the efficacy of malaria chemoprophylaxis from 2 to 12 months of age in infants living in an area of intense and perennial malaria transmission Read more about this study
- Who is it for?
- Ages 1 to 1 dayHealthy volunteers can take part
- What is being tested?
- Deltaprim (3.125 mg pyrimethamine plus 25 mg dapsone) and iron (2 mg/kg/daily)
- How many people
- 832 participants
- Where
- 1 siteTanzania
- Study dates
- Feb 1995to Jul 1999
- 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 1 to 1 day
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Born in San Francis Designated District Hospital of Ifakara
Who cannot join
- Obvious severe congenital malformation such as: spina bifida, hydrocephalus or anencepahlus
- Twins
- Birth weight < 1,5 kg
- Clinical signs of cerebral asphyxia
- Clinical signs of neonatal or congenital infection
- Mother unreliable (deaf, mentally handicapped)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Prevention of Anaemia and Malaria in Infants in an Area of Intense and Perennial Malaria Transmission
The purpose of this trial is to evaluate the efficacy of weekly iron supplementation and the efficacy of malaria chemoprophylaxis from 2 to 12 months of age in infants living in an area of intense and perennial malaria transmission
Read the detailed description
411 Tanzanian infants were randomly assigned to receive weekly malaria prophylaxis with Deltaprim™ (3.125 mg pyrimethamine plus 25 mg dapsone) or placebo from ages 2-12 months. Children were followed-up until age 4 years. Uncomplicated febrile malaria, severe malaria and anaemia morbidity were assessed through hospital-based passive surveillance.
- Being tested
- Deltaprim (3.125 mg pyrimethamine plus 25 mg dapsone), iron (2 mg/kg/daily)
- Keywords
- Plasmodium Falciparum, Antimlarial chemoprophylaxis, Iron supplementation, Tanzania
- Medical subject headings
- Malaria, Anemia, Malaria, Falciparum
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Deltaprim (3.125 mg pyrimethamine plus 25 mg dapsone)Drug
iron (2 mg/kg/daily)Drug
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical Malaria
Measured: During first year of life
Severe Anemia (PCV < 25%)
Measured: During first year of life
Secondary outcomes (5)
Clinical Malaria
Measured: After first year of life
Severe Anemia (PCV < 25%)
Measured: After first year of life
Outpatient visits
Hospital Admissions
Severe malaria
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jul 2007 (estimated)
- Study startFeb 1995
- Study completionJul 1999
Why it stopped: Follow-up end in 1999
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 MalariaStudies of the same condition, open and under way.
- More trials run by Hospital Clinic of BarcelonaThe sponsor's other registered studies.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Double blind
- Enrolment
- 832 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital Clinic of Barcelona
- Sponsor type
- University, hospital or other
- Collaborators
- Agencia Española de Cooperación Internacional, World Health Organization
- Investigators
- Clara Menendez, MD, PhD, Principal investigator, Centre for International Health, Hospital Clinic / Universitat Barcelona
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00497471
- Sponsor's protocol ID
- IronMal
- Status last verified
- Jul 2007
- First submitted
- 5 Jul 2007
- Last updated
- 6 Jul 2007
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Menendez C, Kahigwa E, Hirt R, Vounatsou P, Aponte JJ, Font F, Acosta CJ, Schellenberg DM, Galindo CM, Kimario J, Urassa H, Brabin B, Smith TA, Kitua AY, Tanner M, Alonso PL. Randomised placebo-controlled trial of iron supplementation and malaria chemoprophylaxis for prevention of severe anaemia and malaria in Tanzanian infants. Lancet. 1997 Sep 20;350(9081):844-50. doi: 10.1016/S0140-6736(97)04229-3.
PubMed 9310602
Study at a glance
From the registry record, last updated by the sponsor on 6 Jul 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Prevention of Anaemia and Malaria in Infants in an Area of Intense and Perennial Malaria Transmission
- ClinicalTrials.gov ID
- NCT00497471
- Acronym / sponsor ID
- IronMal
- Keywords
- Plasmodium Falciparum, Antimlarial chemoprophylaxis, Iron supplementation, Tanzania
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Follow-up end in 1999
- Enrolment
- 832 participants (actual)
- Lead sponsor
- Hospital Clinic of BarcelonaUniversity, hospital or other
- Collaborators
- Agencia Española de Cooperación Internacional, World Health Organization
- Study start
- Feb 1995
- Study completion
- Jul 1999 (actual)
- First posted
- 6 Jul 2007 (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.
The purpose of this trial is to evaluate the efficacy of weekly iron supplementation and the efficacy of malaria chemoprophylaxis from 2 to 12 months of age in infants living in an area of intense and perennial malaria transmission
Detailed description
411 Tanzanian infants were randomly assigned to receive weekly malaria prophylaxis with Deltaprim™ (3.125 mg pyrimethamine plus 25 mg dapsone) or placebo from ages 2-12 months. Children were followed-up until age 4 years. Uncomplicated febrile malaria, severe malaria and anaemia morbidity were assessed through hospital-based passive surveillance.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Double blind
Who may qualify
- Ages
- 1 to 1 day
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Born in San Francis Designated District Hospital of Ifakara
Key exclusion criteria (6 listed)
- Obvious severe congenital malformation such as: spina bifida, hydrocephalus or anencepahlus
- Twins
- Birth weight < 1,5 kg
- Clinical signs of cerebral asphyxia
- Clinical signs of neonatal or congenital infection
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 |
|---|---|---|
| Deltaprim (3.125 mg pyrimethamine plus 25 mg dapsone) | Drug | – |
| iron (2 mg/kg/daily) | Drug | – |
Primary outcome
Clinical Malaria
Time frame: During first year of life
Severe Anemia (PCV < 25%)
Time frame: During first year of life
5 secondary outcomes
Clinical Malaria
Time frame: After first year of life
Severe Anemia (PCV < 25%)
Time frame: After first year of life
Outpatient visits
Hospital Admissions
Severe malaria
Results and safety
The study was stopped early (reason given: Follow-up end in 1999). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jul 2007.
- Results publication: PubMed 9310602Menendez C, Kahigwa E, Hirt R, Vounatsou P, Aponte JJ, Font F, Acosta CJ, Schellenberg DM, Galindo CM, Kimario J, Urassa H, Brabin B, Smith TA, Kitua AY, Tanner M, Alonso PL. Randomised placebo-controlled trial of iron supplementation and malaria chemoprophylaxis for prevention of severe anaemia and malaria in Tanzanian infants. Lancet. 1997 Sep 20;350(9081):844-50. doi: 10.1016/S0140-6736(97)04229-3.
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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.
Clara Menendez, MD, PhD principal investigator
Centre for International Health, Hospital Clinic / Universitat Barcelona
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Deltaprim (3.125 mg pyrimethamine plus 25 mg dapsone) and iron (2 mg/kg/daily) in people with Malaria and Anemia, run by Hospital Clinic of Barcelona at 1 site in Tanzania.
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 6 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: stopped early, as of the sponsor's last update on 6 Jul 2007. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Tanzania. Whether a site is taking part right now should be confirmed with that site. See every site.
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 was stopped early (reason given: Follow-up end in 1999). Results are not available in the source record.
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?
Clinical Malaria (time frame: During first year of life). The study lists 2 primary outcomes in all. 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 NCT00497471, 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 6 Jul 2007.