Dataset Information

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.

ABSTRACT:

Background

The safety of iron supplementation for young women is uncertain in malaria-endemic settings.

Methods

This was a double-blind, randomized controlled noninferiority trial in rural Burkina Faso.

Results

A total of 1959 nulliparae were assigned to weekly supplementation (60 mg iron and 2.8 mg folic acid) (n = 980) or 2.8 mg folic acid (n = 979) until first antenatal visit (ANC1), or 18 months if remaining nonpregnant. Three hundred fifteen women attended ANC1, and 916 remained nonpregnant. There was no difference at ANC1 in parasitemia prevalence (iron, 53.4% [95% confidence interval {CI}, 45.7%-61.0%]; control, 55.3% [95% CI, 47.3%-62.9%]; prevalence ratio, 0.97 [95% CI, .79-1.18]; P = .82), anemia (adjusted effect, 0.96 [95% CI, .83-1.10]; P = .52), iron deficiency (adjusted risk ratio [aRR], 0.84 [95% CI, .46-1.54]; P = .58), or plasma iron biomarkers. Outcomes in nonpregnant women were parasitemia (iron, 42.9% [95% CI, 38.3%-47.5%]; control, 39.2% [95% CI, 34.9%-43.7%]; prevalence ratio, 1.09 [95% CI, .93-1.28]; P = .282); anemia (aRR, 0.90 [95% CI, .78-1.05]; P = .17), and iron deficiency (aRR, 0.99 [95% CI, .77-1.28]; P = .96), with no iron biomarker differences.

Conclusions

Weekly iron supplementation did not increase malaria risk, improve iron status, or reduce anemia in young, mostly adolescent menstruating women, nor in early pregnancy. World Health Organization Guidelines for universal supplementation for young nulliparous women may need reassessment.

Clinical trials registration

NCT01210040.

SUBMITTER: Gies S

PROVIDER: S-EPMC6107738 | biostudies-literature | 2018 Aug

REPOSITORIES: biostudies-literature

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Publications

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.

Gies Sabine S Diallo Salou S Roberts Stephen A SA Kazienga Adama A Powney Matthew M Brabin Loretta L Ouedraogo Sayouba S Swinkels Dorine W DW Geurts-Moespot Anneke J AJ Claeys Yves Y D'Alessandro Umberto U Tinto Halidou H Faragher Brian B Brabin Bernard B

The Journal of infectious diseases 20180801 7

<h4>Background</h4>The safety of iron supplementation for young women is uncertain in malaria-endemic settings.<h4>Methods</h4>This was a double-blind, randomized controlled noninferiority trial in rural Burkina Faso.<h4>Results</h4>A total of 1959 nulliparae were assigned to weekly supplementation (60 mg iron and 2.8 mg folic acid) (n = 980) or 2.8 mg folic acid (n = 979) until first antenatal visit (ANC1), or 18 months if remaining nonpregnant. Three hundred fifteen women attended ANC1, and 91 ...[more]

PMID: 29733403

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Project description:Provision of routine iron supplements to prevent anaemia could increase the risk for lower genital tract infections as virulence of some pathogens depends on iron availability. This trial in Burkina Faso assessed whether weekly periconceptional iron supplementation increased the risk of lower genital tract infection in young non-pregnant and pregnant women.Genital tract infections were assessed within a double blind, controlled, non-inferiority trial of malaria risk among nulliparous women, randomised to receive either iron and folic acid or folic acid alone, weekly, under direct observation for 18 months. Women conceiving during this period entered the pregnancy cohort. End assessment (FIN) for women remaining non-pregnant was at 18 months. For the pregnancy cohort, end assessment was at the first scheduled antenatal visit (ANC1). Infection markers included Nugent scores for abnormal flora and bacterial vaginosis (BV), T. vaginalis PCR, vaginal microbiota, reported signs and symptoms, and antibiotic and anti-fungal prescriptions. Iron biomarkers were assessed at baseline, FIN and ANC1. Analysis compared outcomes by intention to treat and in iron replete/deficient categories.A total of 1954 women (mean 16.8 years) were followed and 478 (24.5%) became pregnant. Median supplement adherence was 79% (IQR 59-90%). Baseline BV prevalence was 12.3%. At FIN and ANC1 prevalence was 12.8% and 7.0%, respectively (P?<?0.011). T. vaginalis prevalence was 4.9% at FIN and 12.9% at ANC1 (P?<?0.001). BV and T. vaginalis prevalence and microbiota profiles did not differ at trial end-points. Iron-supplemented non-pregnant women received more antibiotic treatments for non-genital infections (P?=?0.014; mainly gastrointestinal infections (P?=?0.005), anti-fungal treatments for genital infections (P?=?0.014) and analgesics (P?=?0.008). Weekly iron did not significantly reduce iron deficiency prevalence. At baseline, iron-deficient women were more likely to have normal vaginal flora (P?=?0.016).Periconceptional weekly iron supplementation of young women did not increase the risk of lower genital tract infections but did increase general morbidity in the non-pregnant cohort. Unabsorbed gut iron due to malaria could induce enteric infections, accounting for the increased administration of antibiotics and antifungals in the iron-supplemented arm. This finding reinforces concerns about routine iron supplementation in highly malarious areas.Trial registration number NCT01210040 . Registered with Clinicaltrials.gov on 27 September 2010.

Project description:BackgroundIron supplementation before a first pregnancy may improve the future health of mother and baby by reducing maternal anaemia. Iron supplementation could, however, increase malaria infections, notably in primigravidae who are most susceptible. The pathogenicity of other iron-utilizing pathogens could also increase, causing inflammation leading to increased risk of adverse birth outcomes. This paper reports pre-specified secondary birth outcomes from a safety trial in Burkina Faso in an area of high malaria endemicity. Primary outcomes from that trial had investigated effects of long-term weekly iron supplementation on malaria and genital tract infections in non-pregnant and pregnant women.MethodsA double-blind, randomized controlled trial. Nulliparous, mainly adolescent women, were individually randomized periconceptionally to receive weekly either 60 mg elemental iron and 2.8 mg folic acid, or 2.8 mg folic acid alone, continuing up to the first antenatal visit for those becoming pregnant. Secondary outcomes were ultrasound-dated gestational age, fetal growth, placental malaria, chorioamnionitis and iron biomarkers. Seasonal effects were assessed. Analysis was by intention to treat.Results478 pregnancies occurred to 1959 women: 258/980 women assigned iron and folic acid and 220/979 women assigned folic acid alone. Malaria prevalence at the first antenatal visit was 53% (iron) and 55% (controls). Mean birthweight was 111 g lower in the iron group (95% CI 9:213 g, P = 0.033). Mean gestational ages were 264 days (iron) and 269 days (controls) (P = 0.012), with 27.5% under 37 weeks compared to 13.9% in controls (adjRR = 2.22; 95% CI 1.39-3.61) P < 0.001). One-third of babies were growth restricted, but incidence did not differ by trial arm. Half of placentae had evidence of past malaria infection. C-reactive protein > 5 mg/l was more common prior to births < 37 weeks (adjRR = 2.06, 95% CI 1.04-4.10, P = 0.034). Preterm birth incidence during the rainy season was ~ 50% in the iron arm and < 20% in controls (P = 0.001). Chorioamnionitis prevalence peaked in the dry season (P = 0.046), with no difference by trial arm (P = 0.14).ConclusionLong-term weekly iron supplementation given to nulliparous women in a malaria endemic area was associated with higher risk of preterm birth in their first pregnancy. Trial Registration NCT01210040. Registered with Clinicaltrials.gov on 27th September 2010.

Project description:Malaria is a parasitic disease, endemic in many tropical and sub-tropical countries. Malaria is a well-known disease, familiar to almost all people in endemic regions, as they or their family are regularly confronted with it; everyone in these regions has probably experienced the disease, at least once in their life. To investigate the social perceptions of malaria in Burkina Faso, including its diagnosis-driven treatment, we have conducted a survey in both urban (Saint Camille Hospital, Ouagadougou HOSCO) and rural (Boussé Hospital) areas. Fifty-six individuals, mostly representatives of the society variability, were surveyed by questionnaires and 2 focus groups were organized with traditional healers. In general, populations seem to have grasped the causes, symptoms and means of preventing the disease. However, the majority of interviewees make a marked confusion between malaria and dengue; dengue fever is considered like a severe form of malaria. The care modalities (modern and/or traditional medicine) are plural and the choice of therapeutic practice depends on both the socio-economic conditions and education level of the patient. Whereas some patients mark preferences for one type of medicine, others simultaneously recourse to both; for these, a medicine does not outperform the other and their combination multiplies the chances of a quick recovery. Whether for modern or traditional medicine, the diagnosis is considered very important for effective disease management. Modern medicine uses diagnostic tools based on light microscopy and immunochromatography (rapid diagnostic tests; RDT); traditional medicine has its own diagnostic logic but nevertheless recognizes modern medicine diagnosis to guide its therapy. 90 % of those interviewed first use modern medicine to seek an accurate diagnosis of their disease and thus to receive adequate treatment. Presumptive treatments are still widely prescribed and accepted by most patients who trust the judgment of their caregiver, not perceiving any benefit to an objective diagnosis. In front of a negative diagnosis, patient reactions are diverse, some accepting investigations for other diseases (45 %), others opting for self-medication (15 %), others resorting to traditional medicine (20 %). All are unanimous in the importance of diagnosis and are in favor of in-development diagnostic technologies, provided these obviously meet the features of reliability, ease of use, availability and, of course, economical accessibility.

Project description:BackgroundIn the context of widespread mosquito resistance to currently available pesticides, novel, precise genetic vector control methods aimed at population suppression or trait replacement are a potentially powerful approach that could complement existing malaria elimination interventions. Such methods require knowledge of vector population composition, dynamics, behaviour and role in transmission. Here were characterized these parameters in three representative villages, Bana, Pala and Souroukoudingan, of the Sudano-Sahelian belt of Burkina Faso, a region where bed net campaigns have recently intensified.MethodsFrom July 2012 to November 2015, adult mosquitoes were collected monthly using pyrethroid spray catches (PSC) and human landing catches (HLC) in each village. Larval habitat prospections assessed breeding sites abundance at each site. Mosquitoes collected by PSC were identified morphologically, and then by molecular technique to species where required, to reveal the seasonal dynamics of local vectors. Monthly entomological inoculation rates (EIR) that reflect malaria transmission dynamics were estimated by combining the HLC data with mosquito sporozoite infection rates (SIR) identified through ELISA-CSP. Finally, population and EIR fluctuations were fit to locally-collected rainfall data to highlight the strong seasonal determinants of mosquito abundance and malaria transmission in this region.ResultsThe principal malaria vectors found were in the Anopheles gambiae complex. Mosquito abundance peaked during the rainy season, but there was variation in vector species composition between villages. Mean survey HLC and SIR were similar across villages and ranged from 18 to 48 mosquitoes/person/night and from 3.1 to 6.6% prevalence. The resulting monthly EIRs were extremely high during the rainy season (0.91-2.35 infectious bites/person/day) but decreased substantially in the dry season (0.03-0.22). Vector and malaria transmission dynamics generally tracked seasonal rainfall variations, and the highest mosquito abundances and EIRs occurred in the rainy season. However, despite low residual mosquito populations, mosquitoes infected with malaria parasites remained present in the dry season.ConclusionThese results highlight the important vector control challenge facing countries with high EIR despite the recent campaigns of bed net distribution. As demonstrated in these villages, malaria transmission is sustained for large parts of the year by a very high vector abundance and high sporozoite prevalence, resulting in seasonal patterns of hyper and hypo-endemicity. There is, therefore, an urgent need for additional vector control tools that can target endo and exophillic mosquito populations.

Dataset Information

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.

Background

Methods

Results

Conclusions

Clinical trials registration

Publications

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.

Similar Datasets

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