MalariaPhase 4NCT00680732
Prevention of Intrauterine Growth Retardation in Burkina Faso: the Malaria Component
A Phase 4 study testing Multiple micronutrients supplements (MMS), Iron and folic acid (IFA) and Chloroquine (CQ) in people with Malaria and Malaria in Pregnancy, run by Institute of Tropical Medicine, Belgium at 1 site in Burkina Faso.
Trial summary
Our objective was to investigate the importance of malaria infection/disease during pregnancy and more particularly during the first trimester; we also looked at the maternal-foetal interactions and their influence on the subsequent child's response to malaria infections during the first year of life. Read more about this study
- Who is it for?
- Ages 15 to 44 years, women only
- Conditions the study is for
- Malaria, Malaria in Pregnancy
- What is being tested?
- Multiple micronutrients supplements (MMS), Iron and folic acid (IFA) and Chloroquine (CQ)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,370 participants
- Where
- 1 siteBurkina Faso
- Study dates
- Jun 2003to Oct 2006
- Phase
- Phase 4
- 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 15 to 44 years
- Women only
- No healthy volunteers
- Child, Adult
Who may be able to join
- 15 to 44 years
- females
- living in the study area
Who cannot join
- planning to move outside the district within two years
- regularly using a contraceptive methods
- already pregnant at the start of the trial
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Prevention of Intrauterine Growth Retardation in Hounde District, Burkina Faso: the Malaria Component
Our objective was to investigate the importance of malaria infection/disease during pregnancy and more particularly during the first trimester; we also looked at the maternal-foetal interactions and their influence on the subsequent child's response to malaria infections during the first year of life. This study was carried out !in the same population recruited for the IUGR study (NCT00642408).
Read the detailed description
A research project aiming at investigating the impact of multivitamin-mineral supplementation (MMS) during pregnancy on intra-uterin growth retardation was carried out in the Hounde district, an area not far from the Centre Muraz located in Bobo Dioulasso, and where malaria is endemic. Malaria during pregnancy increases the risk of low birth weight, infant mortality and morbidity during the first year of life by inducing growth retardation, prematurity and infant anaemia.
The administration of an antimalarial drug during pregnancy has a beneficial effect on the mother and child's health by preventing malaria infection and its consequences. However, most studies have been carried out during the second or third trimester of pregnancy: the effect of malaria infection during the first trimester on the mother's and child's health is unknown. It has been reported that even one single infection may have a significant impact on the outcome of pregnancy: if it is true, then early chemoprophylaxis may have an additional advantage.
An alternative approach is the administration of intermittent presumptive treatment, which may achieve equal efficacy to continuos chemoprophylaxis; however, no studies compared effective weekly malaria chemoprophylaxis with effective intermittent presumptive treatment. Moreover, the incidence of malaria clinical episodes during SP intermittent preventive treatment has never been investigated.
Therefore, this open label, factorial study was carried out in the same women recruited for the IUGR nutritional study (NCT00642408). Women receiving multiple micronutrients supplements (MMS) or dietary supplements (IFA) were further randomised in 2 groups: CQ weekly chemoprophylaxis or SP intermittent preventive treatment. The administration of treatment was directly observed.
- Conditions
- Malaria, Malaria in Pregnancy
- Being tested
- Multiple micronutrients supplements (MMS), Iron and folic acid (IFA), Chloroquine (CQ), Sulphadoxyne-pyrimethamine (SP)
- Keywords
- Malaria, Pregnancy, Prevention, Chloroquine, Sulphadoxine pyrimethamine, Maternal anaemia, Birth weight, Foetal anaemia
- Medical subject headings
- Malaria, Birth Weight
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Multiple micronutrients supplements (MMS)Dietary supplement
Also called UNIMMAP
Vitamin A 800 mcg; vitamin E 10 mg; vitamin D 5 mcg; vitamin B1 1.4 mg; vitamin B2 1.4 mg;niacin 18 mg; vitamin B6 1.9 mg; vitamin B12 2.6 mcg; folic acid 400 mcg; vitamin C 70 mg; iron 30 mg; zinc 15 mg; copper 2 mg; selenium 65 mcg; iodine 150 mcg
Iron and folic acid (IFA)Dietary supplement
Iron 60 mg and folic acid 400 mcg
Chloroquine (CQ)Drug
Tablets 100 mg of chloroquine base
Sulphadoxyne-pyrimethamine (SP)Drug
Also called Fansidar
Tablets
| Study group | Role | What they receive |
|---|---|---|
| A1 | Experimental | Multiple micronutrients supplements (MMS) and weekly chloroquine (CQ) Receives: Dietary Supplement: Multiple micronutrients supplements (MMS); Drug: Chloroquine (CQ) |
| A2 | Experimental | Multiple micronutrients supplements (MMS) and intermittent suplphadoxyne-pyrimethamine (SP) Receives: Dietary Supplement: Multiple micronutrients supplements (MMS); Drug: Sulphadoxyne-pyrimethamine (SP) |
| B1 | Experimental | Iron and folic acid (IFA) and weekly chloroquine (CQ) Receives: Dietary Supplement: Iron and folic acid (IFA); Drug: Chloroquine (CQ) |
| B2 | Experimental | Iron and folic acid (IFA) and intermittent sulphadoxyne-pyrimethamine (SP) Receives: Dietary Supplement: Iron and folic acid (IFA); Drug: Sulphadoxyne-pyrimethamine (SP) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Efficacy of standard antimalarial treatment in preventing clinical malaria in pregnant women under weekly chemoprophylaxis or intermittent treatment.
Measured: Up to delivery
Secondary outcomes (3)
To determine if the occurrence of malaria during pregnancy influences the incidence of clinical malaria in infants during their first year of life.
Measured: Up to one year after delivery
To determine the burden of clinical malaria during pregnancy and its consequences on maternal anaemia, new birth weight and foetal anaemia.
Measured: Up to delivery
Effect of standard antimalarial treatment on the selection of resistant parasites in pregnant women under weekly chemoprophylaxis or intermittent treatment.
Measured: Up to one year after delivery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 May 2008 (estimated)
- Study startJun 2003
- Primary completionOct 2006
- Study completionOct 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MalariaStudies 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 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Enrolment
- 1,370 participants (actual)
Sponsor and investigators
- Lead sponsor
- Institute of Tropical Medicine, Belgium
- Sponsor type
- University, hospital or other
- Collaborators
- Departments of Parasitology and Public Health, ITM, Antwerp, Belgium, Centre Muraz, Laboratoire National de Santé Publique, Ouagadougou, Burkina Faso
- Investigators
- Marie Claire Henry, MD, Principal investigator, Centre Muraz
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00680732
- Sponsor's protocol ID
- IUGR Malaria
- Status last verified
- Sep 2010
- First submitted
- 23 Apr 2008
- Last updated
- 14 Sep 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Sep 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevention of Intrauterine Growth Retardation in Hounde District, Burkina Faso: the Malaria Component
- ClinicalTrials.gov ID
- NCT00680732
- Acronym / sponsor ID
- IUGR Malaria
- Conditions
- Malaria, Malaria in Pregnancy
- Keywords
- Malaria, Pregnancy, Prevention, Chloroquine, Sulphadoxine pyrimethamine, Maternal anaemia, Birth weight, Foetal anaemia
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,370 participants (actual)
- Lead sponsor
- Institute of Tropical Medicine, BelgiumUniversity, hospital or other
- Collaborators
- Departments of Parasitology and Public Health, ITM, Antwerp, Belgium, Centre Muraz, Laboratoire National de Santé Publique, Ouagadougou, Burkina Faso
- Study start
- Jun 2003
- Primary completion
- Oct 2006 (actual)
- Study completion
- Oct 2006 (actual)
- First posted
- 20 May 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.
Our objective was to investigate the importance of malaria infection/disease during pregnancy and more particularly during the first trimester; we also looked at the maternal-foetal interactions and their influence on the subsequent child's response to malaria infections during the first year of life. This study was carried out !in the same population recruited for the IUGR study (NCT00642408).
Detailed description
A research project aiming at investigating the impact of multivitamin-mineral supplementation (MMS) during pregnancy on intra-uterin growth retardation was carried out in the Hounde district, an area not far from the Centre Muraz located in Bobo Dioulasso, and where malaria is endemic. Malaria during pregnancy increases the risk of low birth weight, infant mortality and morbidity during the first year of life by inducing growth retardation, prematurity and infant anaemia.
The administration of an antimalarial drug during pregnancy has a beneficial effect on the mother and child's health by preventing malaria infection and its consequences. However, most studies have been carried out during the second or third trimester of pregnancy: the effect of malaria infection during the first trimester on the mother's and child's health is unknown. It has been reported that even one single infection may have a significant impact on the outcome of pregnancy: if it is true, then early chemoprophylaxis may have an additional advantage.
An alternative approach is the administration of intermittent presumptive treatment, which may achieve equal efficacy to continuos chemoprophylaxis; however, no studies compared effective weekly malaria chemoprophylaxis with effective intermittent presumptive treatment. Moreover, the incidence of malaria clinical episodes during SP intermittent preventive treatment has never been investigated.
Therefore, this open label, factorial study was carried out in the same women recruited for the IUGR nutritional study (NCT00642408). Women receiving multiple micronutrients supplements (MMS) or dietary supplements (IFA) were further randomised in 2 groups: CQ weekly chemoprophylaxis or SP intermittent preventive treatment. The administration of treatment was directly observed.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| A1 | Experimental | Dietary Supplement: Multiple micronutrients supplements (MMS), Drug: Chloroquine (CQ)Multiple micronutrients supplements (MMS) and weekly chloroquine (CQ) |
| A2 | Experimental | Dietary Supplement: Multiple micronutrients supplements (MMS), Drug: Sulphadoxyne-pyrimethamine (SP)Multiple micronutrients supplements (MMS) and intermittent suplphadoxyne-pyrimethamine (SP) |
| B1 | Experimental | Dietary Supplement: Iron and folic acid (IFA), Drug: Chloroquine (CQ)Iron and folic acid (IFA) and weekly chloroquine (CQ) |
| B2 | Experimental | Dietary Supplement: Iron and folic acid (IFA), Drug: Sulphadoxyne-pyrimethamine (SP)Iron and folic acid (IFA) and intermittent sulphadoxyne-pyrimethamine (SP) |
Who may qualify
- Ages
- 15 to 44 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- 15 to 44 years
- females
- living in the study area
Key exclusion criteria (3 listed)
- planning to move outside the district within two years
- regularly using a contraceptive methods
- already pregnant at the start of the trial
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 |
|---|---|---|
| Multiple micronutrients supplements (MMS)Also: UNIMMAPVitamin A 800 mcg; vitamin E 10 mg; vitamin D 5 mcg; vitamin B1 1.4 mg; vitamin B2 1.4 mg;niacin 18 mg; vitamin B6 1.9 mg; vitamin B12 2.6 mcg; folic acid 400 mcg; vitamin C 70 mg; iron 30 mg; zinc 15 mg; copper 2 mg; selenium 65 mcg; iodine 150 mcg | Dietary supplement | A1, A2 |
| Iron and folic acid (IFA)Iron 60 mg and folic acid 400 mcg | Dietary supplement | B1, B2 |
| Chloroquine (CQ)Tablets 100 mg of chloroquine base | Drug | A1, B1 |
| Sulphadoxyne-pyrimethamine (SP)Also: FansidarTablets | Drug | A2, B2 |
Primary outcome
Efficacy of standard antimalarial treatment in preventing clinical malaria in pregnant women under weekly chemoprophylaxis or intermittent treatment.
Time frame: Up to delivery
3 secondary outcomes
To determine if the occurrence of malaria during pregnancy influences the incidence of clinical malaria in infants during their first year of life.
Time frame: Up to one year after delivery
To determine the burden of clinical malaria during pregnancy and its consequences on maternal anaemia, new birth weight and foetal anaemia.
Time frame: Up to delivery
Effect of standard antimalarial treatment on the selection of resistant parasites in pregnant women under weekly chemoprophylaxis or intermittent treatment.
Time frame: Up to one year after delivery
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 14 Sep 2010.
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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.
Marie Claire Henry, MD principal investigator
Centre Muraz
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Multiple micronutrients supplements (MMS), Iron and folic acid (IFA) and Chloroquine (CQ) in people with Malaria and Malaria in Pregnancy, run by Institute of Tropical Medicine, Belgium at 1 site in Burkina Faso.
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 3 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 14 Sep 2010. 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 Burkina Faso. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Efficacy of standard antimalarial treatment in preventing clinical malaria in pregnant women under weekly chemoprophylaxis or intermittent treatment. (time frame: Up to delivery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 14 Sep 2010.