跳至主要内容
临床试验/NCT04238845
NCT04238845Unknown不适用

Assessment of a Combined Strategy of Seasonal Malaria Chemoprevention + Supplementation With PlumpyDoz and Vitamin A-Zinc to Prevent Malaria and Malnutrition in Burkina Faso

Institut de Recherche en Sciences de la Sante, Burkina Faso1 个研究点 分布在 1 个国家目标入组 1,059 人开始时间: 2020年7月13日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
发起方
入组人数
1,059
试验地点
1
主要终点
The mid-upper arm circumference gain

研究概览

简要总结

Malaria and malnutrition represent major public health concerns worldwide especially in Sub-Sahara Africa. Despite implementation of Seasonal Malaria Chemoprophylaxis (SMC), an intervention aimed at reducing malaria prevalence among children aged 6- 59 months, the burden of malaria and associated mortality among children below age 5 years remains high in Burkina Faso. This raises the question of what hiding factors may negatively affect the responsiveness of SMC intervention. Malnutrition, in particular micronutrient deficiency, is one of these potential factors that can negatively affect the effectiveness of SMC. Treating micronutrient deficiencies is known to reduce the prevalence of malaria mortality in highly prevalent malaria zone such as rural settings. Therefore, the hypothesis that a combined strategy of SMC together with a daily oral nutrients supplement (Vitamin A-Zinc OR fortified peanut butter-like paste-Plumpy'Doz) will enhance the immune response and decrease the incidence of malaria in this population and at the same time reduce the burden of malnutrition among children under SMC coverage was postulated.

Prior to the SMC implementation by the National Malaria Control Program (NMCP), children under SMC coverage will be identified through the Health and Demographic Surveillance System (HDSS). Children will be randomly assigned to one of the three groups (a) SMC + Vitamin A alone, (b) SMC + Vitamin A+ Zinc, or (c) SMC+Vitamin A + Plumpy'Doz. After each SMC monthly distribution, children will be visited at home to confirm drug administration and follow-up for one year. Anthropometric indicators will be recorded at each visit. Blood samples will be collected for thick and thin film and hemoglobin measurement and spotted onto filter paper for further PCR analyses.

This project will serve as a pilot of an integrated strategy in order to mutualize resources for best impact. By relying on existing strategies, the policy implementation of this joint intervention will be scalable at country and regional levels.

详细描述

Malaria is hyper-endemic in Burkina Faso and many sub-Saharan Africa countries. According to the National Malaria Control Program (NMCP) approximately 11 915 816 malaria cases and 4 144 malaria-related deaths were reported in 2017 in Burkina Faso. Numerous malaria control interventions have been implemented in Burkina Faso in order to achieve the 2030 Sustainable Development Goal (SDG) 3. Seasonal malaria chemo-prevention (SMC) ranks among the largest and reliable interventions for malaria control in countries with marked seasonality of malaria transmission. This preventive measures involves administering antimalarial drugs (Amodiaquine-Sulfadoxine-Pyrimethamine) to children aged 6- 59 months on a monthly basis during the high transmission peak. In Burkina Faso, SMC is implemented from July/August to October/November each year. SMC is recommended by the World Health Organization (WHO) and is known to reduce malaria morbidity by 30 to 80%. Despite the implementation of this strategy, the burden of malaria and associated mortality is still very high in this population in Burkina Faso. This raises questions about other hidden factors that can negatively affect the effectiveness of SMC intervention.

At the same time, malnutrition is a major cause of childhood morbidity and mortality in low- and middle-income countries such as Burkina Faso. Malnutrition can lower immune system leading to increased severity of malaria in the population. The National Nutrition Program (NPP), which is the agency established to address malnutrition problems in Burkina Faso, currently aims to scale-up Community Management of Acute Malnutrition (CMAM). Both malaria and malnutrition are highly prevalent in rural settings. Furthermore, malaria seasonal peak coincides with period of food crisis in the country suggesting that malnutrition may influence malaria incidence during that period. Children under five years again represent the most vulnerable group. Importantly, treating micronutrient deficiencies is known to reduce malaria morbidity and mortality. Plumpy'Doz is specifically formulated for prevention of malnutrition in children from 6 months of age and adults. It has been recommended since 2007 by the WHO, UN Children's Fund (UNICEF), World Food Program (WFP), and the UN Standing Committee on Nutrition in the joint declaration on community-based management of severe acute malnutrition. Evidence also shows that Vitamin A-Zinc supplementation reduce malaria morbidity. A reduction by 20-30% of malaria incidence through micronutrient supplementation such as Vitamin A-Zinc has also been reported.

These aspects underlie the idea of the SMC-Nutrition project. This combined strategy could enhance the immune response and therefore decrease the severity of malaria in this population and at the same time reduce the burden of malnutrition in children under SMC coverage. This project will serve as a pilot integrated strategy in order to mutualize resources for best impact. By relying on existing strategies, the policy implementation of this joint intervention will be scalable at country and regional levels. If the pilot produces promising results, a large-scale multi-centric assessment of the strategy will be performed in several SMC countries (i.e. Niger, Mali and Burkina Faso).

Purpose and objective(s) Aim 1: To assess the feasibility of combining two different strategies led by different programs (malaria and nutrition) which affect the same target population (children under five years). SMC is a larger community-based intervention at a national level led by the NMCP. National Nutrition Program is trying to scale up the Community Management of Acute Malnutrition (CMAM). This project will serve as a pilot of integrated strategy in order to mutualize resources for best impact. By relying on existing strategies, the policy implementation of this joint intervention will be scalable at country and regional levels.

Aim 2: To boost the impact of SMC intervention in terms of reducing malaria morbidity, mortality and reduce the burden of malnutrition and anaemia in children under five years through supplementation with micronutrients and Vitamin A-Zinc.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
None

入排标准

年龄范围
6 Months 至 59 Months(Child)
性别
All
接受健康志愿者

入选标准

  • Children under SMC coverage (6-59months old),
  • living within the HDSS coverage area,
  • ability to complete the study follow-up period,
  • written consent obtained from parents

排除标准

  • individual not under SMC coverage,
  • Children under SMC coverage who did not receive the treatment (Amodiaquine-Sulfadoxine-Pyrimethamine) or the Vitamin Supplementation,
  • ill individual at the time of the enrolment including uncomplicated/severe malaria or severe malnutrition,
  • known allergy to Vitamin A or Zinc or Plumpy'Doz,
  • planned travel or inability to complete the study follow-up,
  • and unwillingness to participate to the study.

研究组 & 干预措施

SMC+ Vitamin A + Plumpy'Doz

Experimental

Children under SMC Coverage, receiving AQSP + Vitamin A plus Plumpy'Doz supplementation

干预措施: AQSP Administration (Drug)

SMC + Vitamin A alone

Active Comparator

Children under SMC Coverage, receiving AQSP and Vitamin A supplementation alone

干预措施: AQSP Administration (Drug)

SMC + Vitamin A alone

Active Comparator

Children under SMC Coverage, receiving AQSP and Vitamin A supplementation alone

干预措施: Supplementation with Vitamin A (Dietary Supplement)

SMC+ Vitamin A + Plumpy'Doz

Experimental

Children under SMC Coverage, receiving AQSP + Vitamin A plus Plumpy'Doz supplementation

干预措施: Supplementation with Plumpy'Doz (Dietary Supplement)

SMC+ Vitamin A + Plumpy'Doz

Experimental

Children under SMC Coverage, receiving AQSP + Vitamin A plus Plumpy'Doz supplementation

干预措施: Supplementation with Vitamin A (Dietary Supplement)

SMC+ Vitamin A + Zinc

Experimental

Children under SMC Coverage, receiving AQSP + Vitamin A plus Zinc supplementation

干预措施: AQSP Administration (Drug)

SMC+ Vitamin A + Zinc

Experimental

Children under SMC Coverage, receiving AQSP + Vitamin A plus Zinc supplementation

干预措施: Supplementation with Vitamin A (Dietary Supplement)

SMC+ Vitamin A + Zinc

Experimental

Children under SMC Coverage, receiving AQSP + Vitamin A plus Zinc supplementation

干预措施: Supplementation with Zinc (Dietary Supplement)

结局指标

主要结局

The mid-upper arm circumference gain

时间窗: One year

The difference between baseline MUAC and MUAC at the end of the study period in the intervention groups compared to the control group

Weight gain

时间窗: One year

Difference between weight at baseline and weight at the end of the study

prevalence of anemia

时间窗: one year

prevalence of anemia in each arm

The relative risk of the incidence of clinical malaria

时间窗: One year

The ration of the number of malaria cases in intervention over comparator arm hospitalisation and mortality in SMC group compared to SMC + supplement groups

次要结局

  • The prevalence of mutant pfmdr1 allele(One year)
  • The incidence of adverse events in each study group will be considered(Six months)
  • The prevalence of mutant dhfr allele(One year)
  • The prevalence of mutant pfcrt allele(One year)
  • The prevalence of mutant dhps allele(One year)
  • SMC coverage(Six months)
  • SMC Compliance(Six months)

研究者

发起方
Institut de Recherche en Sciences de la Sante, Burkina Faso
申办方类型
Other Gov
责任方
Sponsor

研究点 (1)

Loading locations...

相似试验