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| ID | Type | Description | Link |
|---|---|---|---|
| 1U01HD061234-01A1 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| Institute of Tropical Medicine, Belgium | OTHER |
| University of Manchester | OTHER |
| Institut de Recherche en Sciences de la Sante-Direction Regionale de l'Ouest | OTHER_GOV |
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A randomized double-blind controlled trial will be carried out in which young, nulliparous (having never given birth) women will be randomly assigned to receive weekly supplementation with either iron and folic acid or folic acid alone. Women will be followed-up weekly up to 18 months. Women who become pregnant will be followed-up until delivery. Malaria risk in both groups will be compared by assessing the prevalence of peripheral parasitaemia at the first antenatal clinic visit for pregnant women and at the end of the first malaria transmission season for non-pregnant women. The incidence of clinical malaria will be assessed by active and passive case detection throughout the follow-up period.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Folic Acid | Active Comparator | 2.8mg of Folic Acid given weekly |
|
| Folic Acid and Iron | Experimental | 2.8mg Folic Acid and 60mg Iron given weekly |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Folic Acid | Dietary Supplement | 2.8mg |
| |
| Folic Acid and Iron |
| Measure | Description | Time Frame |
|---|---|---|
| Prevalence of peripheral parasitaemia at first antenatal clinic visit (13-16 weeks gestation) | Completed | Nov 2013 |
| Measure | Description | Time Frame |
|---|---|---|
| a) In the pregnant cohort: Prevalence of iron deficiency at first antenatal visit | Completed | Sept 2013 |
| a) In the pregnant cohort: Prevalence of anaemia at first antenatal clinic visit | Completed |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Bernard J BRABIN, Professor | Liverpool School of Tropical Medicine | Study Director |
| Sabine GIES, MD, MTropMed, PhD | Clinical Research Unit Nanoro (CRUN) | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Institute de Recherche en Sciences de la Sante, Direction Regionale de l'Ouest (IRSS-DRO) - / Centre Muraz | Bobo-Dioulasso | 01 B.P. 545 | Burkina Faso |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31771607 | Derived | Brabin B, Tinto H, Roberts SA. Testing an infection model to explain excess risk of preterm birth with long-term iron supplementation in a malaria endemic area. Malar J. 2019 Nov 26;18(1):374. doi: 10.1186/s12936-019-3013-6. | |
| 31060615 | Derived | Brabin B, Gies S, Roberts SA, Diallo S, Lompo OM, Kazienga A, Brabin L, Ouedraogo S, Tinto H. Excess risk of preterm birth with periconceptional iron supplementation in a malaria endemic area: analysis of secondary data on birth outcomes in a double blind randomized controlled safety trial in Burkina Faso. Malar J. 2019 May 6;18(1):161. doi: 10.1186/s12936-019-2797-8. |
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| ID | Term |
|---|---|
| D008288 | Malaria |
| D000090463 | Iron Deficiencies |
| ID | Term |
|---|---|
| D011528 | Protozoan Infections |
| D010272 | Parasitic Diseases |
| D007239 | Infections |
| D000096724 | Mosquito-Borne Diseases |
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| ID | Term |
|---|---|
| D005492 | Folic Acid |
| D007501 | Iron |
| ID | Term |
|---|---|
| D011622 | Pterins |
| D011621 | Pteridines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
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| Centre Muraz |
| OTHER |
| National Institutes of Health (NIH) | NIH |
| Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) | NIH |
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| Dietary Supplement |
60mg Iron and 2.8mg Folic Acid |
|
| Sept 2013 |
| a) In the pregnant cohort: Incidence of clinical malaria during the first and subsequent trimesters | Completed | Jan 2014 |
| a) In the pregnant cohort: Incidence of adverse pregnancy outcomes | Completed | Jan 2014 |
| a) In the pregnant cohort: Mean birth weight and prevalence of low birth weight (<2500g) | Completed | Jan 2014 |
| a) In the pregnant cohort: Mean gestational age at delivery | Completed | Jan 2014 |
| a) In the pregnant cohort: Prevalence of placental malaria | Completed | Jan 2014 |
| a) In the non-pregnant cohort: Prevalence of peripheral parasitaemia during the first rainy season after at least six months of supplementation | Completed | Nov 2012 |
| a) In the non-pregnant cohort: Incidence of clinical malaria | Completed | Nov 2013 |
| a) In the non-pregnant cohort: Incidence of gastrointestinal adverse events | Completed | Nov 2013 |
| a) In the non-pregnant cohort: Prevalence of iron deficiency after at least 18 months supplementation | Completed | Nov 2013 |
| a) In the non-pregnant cohort: Prevalence of anaemia after at least 18 months supplementation | Completed | Nov 2013 |
| a) In the non-pregnant cohort: Adherence to supplementation | Completed | Nov 2013 |
| a) In the non-pregnant cohort: Acceptability of weekly supplementation | Completed | June 2013 |
| In the non-pregnant cohort: Prevalence of bacterial vaginosis at end assessment | Completed | Nov 2013 |
| a) In the non-pregnant cohort: Prevalence of bacterial vaginosis at end assessment | Completed | Nov 2013 |
| a) In the non-pregnant cohort: Prevalence of bacterial vaginosis at first antenatal visit | Completed | Nov 2013 |
| a) In the non-pregnant cohort: Prevalence of iron deficiency at key study visits | Completed | Nov 2013 |
| a) In the non-pregnant cohort: Prevalence of peripheral parasitaemia at end assessment | Completed | Nov 2013 |
| 30737046 | Derived | Diallo S, Roberts SA, Gies S, Rouamba T, Swinkels DW, Geurts-Moespot AJ, Ouedraogo S, Ouedraogo GA, Tinto H, Brabin BJ. Malaria early in the first pregnancy: Potential impact of iron status. Clin Nutr. 2020 Jan;39(1):204-214. doi: 10.1016/j.clnu.2019.01.016. Epub 2019 Jan 26. |
| 29733403 | Derived | Gies S, Diallo S, Roberts SA, Kazienga A, Powney M, Brabin L, Ouedraogo S, Swinkels DW, Geurts-Moespot AJ, Claeys Y, D'Alessandro U, Tinto H, Faragher B, Brabin B. Effects of Weekly Iron and Folic Acid Supplements on Malaria Risk in Nulliparous Women in Burkina Faso: A Periconceptional, Double-Blind, Randomized Controlled Noninferiority Trial. J Infect Dis. 2018 Aug 24;218(7):1099-1109. doi: 10.1093/infdis/jiy257. |
| 29540225 | Derived | Compaore A, Gies S, Brabin B, Tinto H, Brabin L. Community approval required for periconceptional adolescent adherence to weekly iron and/or folic acid supplementation: a qualitative study in rural Burkina Faso. Reprod Health. 2018 Mar 14;15(1):48. doi: 10.1186/s12978-018-0490-y. |
| 29166928 | Derived | Brabin L, Roberts SA, Gies S, Nelson A, Diallo S, Stewart CJ, Kazienga A, Birtles J, Ouedraogo S, Claeys Y, Tinto H, d'Alessandro U, Faragher EB, Brabin B. Effects of long-term weekly iron and folic acid supplementation on lower genital tract infection - a double blind, randomised controlled trial in Burkina Faso. BMC Med. 2017 Nov 23;15(1):206. doi: 10.1186/s12916-017-0967-5. |
| D000079426 |
| Vector Borne Diseases |
| D019189 | Iron Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D006571 | Heterocyclic Compounds |
| D019216 | Metals, Heavy |
| D004602 | Elements |
| D007287 | Inorganic Chemicals |
| D028561 | Transition Elements |
| D008670 | Metals |