Long-term Iron Supplements and Malaria Risk in Early Pregnancy: a Randomized Controlled Trial

Study Overview
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Brief Summary
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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.

Official Title
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Malaria Risk Prior to and During Early Pregnancy in Nulliparous Women Receiving Long-term Weekly Iron and Folic Acid Supplementation (WIFS): a Non-inferiority Randomized Controlled Trial

Conditions
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Malaria

Intervention / Treatment
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* Dietary Supplement: Folic Acid
* Dietary Supplement: Folic Acid and Iron


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Female At least 15 and less than 25 years old at enrolment Never given birth Resident within the Demographic Surveillance System (DSS) area Willing to adhere to the study requirements (including weekly observed drug intake) Provision of written informed consent (if non emancipated minor by guardian/parent with minor's assent Exclusion Criteria: No menses for >3 months and/or palpable uterus or positive pregnancy test if history unclear Concurrent enrolment in another study Intention to move out of the study area for more than 2 months within the next 18 months Any significant illness at the time of screening that requires hospitalization, including clinical signs of severe anaemia (conjunctival or mucosal pallor, tachycardia, respiratory distress) History or presence of major clinical disease likely to influence pregnancy outcome (sickle cell disease, diabetes mellitus, severe renal or heart disease, open tuberculosis, epilepsy)

Ages Eligible for Study
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Minimum Age: 15 Years
Maximum Age: 24 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Folic Acid<br>2.8mg of Folic Acid given weekly | Dietary Supplement: Folic Acid<br>* 2.8mg<br>|
| Experimental: Folic Acid and Iron<br>2.8mg Folic Acid and 60mg Iron given weekly | Dietary Supplement: Folic Acid and Iron<br>* 60mg Iron and 2.8mg Folic Acid<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Prevalence of peripheral parasitaemia at first antenatal clinic visit (13-16 weeks gestation) | Completed | Nov 2013 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Pregnancy, Iron deficiency, Iron supplementation, Burkina Faso