The Effects of Zinc Supplementation in Children With Sickle Cell Disease in Western Kenya: a Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 40
- 主要终点
- Measurement of change in zinc levels from baseline at study conclusion.
研究概览
简要总结
Zinc is a nutritionally essential trace element found in previous studies to reduce growth retardation and improve immune function, which may also result in decreased incidence of infectious diseases including malaria, pneumonia and diarrhea. Sickle Cell Disease (SCD) patients are known to be susceptible to zinc deficiency and appear to benefit from zinc supplementation. The proposed pilot research project aims to investigate the influence of zinc supplementation on incidence of malaria infections, incidence of bacterial infections and investigate the influence of zinc supplementation on morbidity in children with SCD in western Kenya. The differences in incidence of morbidity and other secondary endpoints will be compared between the zinc group and the control group.
详细描述
Zinc is a nutritionally essential trace element found in previous studies to reduce growth retardation and improve immune function, which may also result in decreased incidence of infectious diseases including malaria, pneumonia and diarrhea. SCD patients are known to be susceptible to zinc deficiency and appear to benefit from zinc supplementation. Despite these findings, SCD patients in Kenya have not benefited from zinc supplementation programs due to a lack of research and findings to inform policy in the East African-setting. The proposed pilot research project aims to investigate the influence of zinc supplementation on incidence of malaria infections in children with SCD; investigate the influence of zinc supplementation on incidence of bacterial infections (e.g. S pneumoniae, H influenzae and non-typhi Salmonella species) in children with SCD and investigate the influence of zinc supplementation on morbidity in children with SCD in western Kenya. A 6 month randomized controlled pilot trial involving children with SCD aged 6 months to less than 13 years, being treated and followed up routinely at the KEMRI-site and other selected health facilities in Western Kenya for SCD will be enrolled. The children will be randomized into two arms, with the Intervention Group receiving the recommended Ministry of Health (MoH)/World Health Organization (WHO) standard care in addition to three times weekly zinc supplementation (10 mg) and the Control Group receiving standard MoH care alone over a six month period. At baseline, at 3 months and at 6 months, clinical and laboratory evaluations, including serum zinc levels, malaria blood slides, anthropometric measurements and other indicated laboratory tests will be conducted.The differences in incidence of morbidity and other secondary endpoints will be compared between the zinc group and the control group. The results are expected to determine the scientific basis for a larger clinical trial to determine the need for the addition of zinc supplement to the management of sickle cell disease.
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 12 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female infants and children ≥ 6 months and < 13 years of age with confirmed SCD.
- •Written informed consent obtained from the participant's parent/Legally Acceptable Representative (LAR).
- •Available to participate for the study duration (approximately six months)
排除标准
- •Written informed consent NOT obtained from the participant's parent/Legally Acceptable Representative (LAR).
- •Profound clinical evidence of current immunosuppression or evidence of active AIDS defining illness i.e. WHO HIV clinical stage III/IV
- •History of allergic reactions to zinc or any other ingredients in the supplement
- •History of any neurologic disorders or seizures
- •Acute or chronic, clinically significant pulmonary, cardiovascular, hepatic, renal functional abnormality, as determined by physical examination or laboratory screening tests
- •Hemoglobin ≤7.0 g/dL in children aged 6 months to ≤ 2 years.
- •Hemoglobin ≤ 6 g/dL in children aged >2yrs to <13 years.
- •Total White Cell Count below normal range <4.5 x 103/uL
- •Use of any investigational or non-registered drugs or vaccines or planned use
- •Simultaneous participation in any other clinical trial
- •Any other findings that the investigator feels would increase the risk of having an adverse outcome from participation in the trial.
研究组 & 干预措施
Zinc Sulfate Tablet
Zinc Sulfate Tablet 10 mg, 3 times a week plus Standard of Care for 6 months
干预措施: Zinc Sulfate Tablets (Dietary Supplement)
Zinc Sulfate Tablet
Zinc Sulfate Tablet 10 mg, 3 times a week plus Standard of Care for 6 months
干预措施: Standard of Care (Drug)
Control Arm
Standard of Care for 6 months
干预措施: Standard of Care (Drug)
结局指标
主要结局
Measurement of change in zinc levels from baseline at study conclusion.
时间窗: 6 months
Zinc Levels in Plasma
次要结局
- Number of episodes of bacterial infections among recipients of zinc versus controls diagnosed by culture.(6 months)
- Number of malaria episodes among recipients of zinc versus controls diagnosed by RDT or Microscopy.(6 months)
- Incidence of malnutrition among recipients of zinc versus controls diagnosed based on anthropometric measurements.(6 months)
- Occurrences of Adverse Events (AEs) during the 6 month follow-up period among recipients of zinc versus controls.(6 months)
研究者
Lucas Otieno Tina, MD MSc
Principal Investigator
Kenya Medical Research Institute