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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
QUADRUPLE
Enrollment
1,959
2.8mg
60mg Iron and 2.8mg Folic Acid
Institute de Recherche en Sciences de la Sante, Direction Regionale de l'Ouest (IRSS-DRO) - / Centre Muraz
Bobo-Dioulasso, Burkina Faso
Prevalence of peripheral parasitaemia at first antenatal clinic visit (13-16 weeks gestation)
Completed
Time frame: Nov 2013
a) In the pregnant cohort: Prevalence of iron deficiency at first antenatal visit
Completed
Time frame: Sept 2013
a) In the pregnant cohort: Prevalence of anaemia at first antenatal clinic visit
Completed
Time frame: Sept 2013
a) In the pregnant cohort: Incidence of clinical malaria during the first and subsequent trimesters
Completed
Time frame: Jan 2014
a) In the pregnant cohort: Incidence of adverse pregnancy outcomes
Completed
Time frame: Jan 2014
a) In the pregnant cohort: Mean birth weight and prevalence of low birth weight (<2500g)
Completed
Time frame: Jan 2014
a) In the pregnant cohort: Mean gestational age at delivery
Completed
Time frame: Jan 2014
a) In the pregnant cohort: Prevalence of placental malaria
Completed
Time frame: 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
Time frame: Nov 2012
a) In the non-pregnant cohort: Incidence of clinical malaria
Completed
Time frame: Nov 2013
a) In the non-pregnant cohort: Incidence of gastrointestinal adverse events
Completed
Time frame: Nov 2013
a) In the non-pregnant cohort: Prevalence of iron deficiency after at least 18 months supplementation
Completed
Time frame: Nov 2013
a) In the non-pregnant cohort: Prevalence of anaemia after at least 18 months supplementation
Completed
Time frame: Nov 2013
a) In the non-pregnant cohort: Adherence to supplementation
Completed
Time frame: Nov 2013
a) In the non-pregnant cohort: Acceptability of weekly supplementation
Completed
Time frame: June 2013
In the non-pregnant cohort: Prevalence of bacterial vaginosis at end assessment
Completed
Time frame: Nov 2013
a) In the non-pregnant cohort: Prevalence of bacterial vaginosis at end assessment
Completed
Time frame: Nov 2013
a) In the non-pregnant cohort: Prevalence of bacterial vaginosis at first antenatal visit
Completed
Time frame: Nov 2013
a) In the non-pregnant cohort: Prevalence of iron deficiency at key study visits
Completed
Time frame: Nov 2013
a) In the non-pregnant cohort: Prevalence of peripheral parasitaemia at end assessment
Completed
Time frame: Nov 2013
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