Effect of Vitamin D Supplementation on Sickle Cell Disease Hospitalisation and Related Complications Among Children in Mulago Hospital: A Randomised Clinical Trial
试验速览
- 阶段
- 不适用
- 入组人数
- 662
- 主要终点
- Frequency of hospitalisation among children with SCD supplemented with vitamin D versus placebo.
研究概览
简要总结
Children aged 6 months to 12 years of age will be randomised to receive vitamin D 60,000IU once a month for 3 months or a placebo. The vitamin D will be in form of granules supplied in sachets. The primary study outcomes will be incidence of hospitalisation and change in vitamin D levels following supplementation. Secondary outcomes will include incidence of vaso-occlusive crisis (VOC), acute severe respiratory illness, Vitamin D related Severe adverse events and requirements for blood transfusion
详细描述
BACKGROUND: More than 75% of all children with sickle cell anemia (SCA) are born in sub-Saharan Africa annually. The hallmark of SCA is haemolytic anaemia and or pain crisis that often require hospitalisation. Interventions to reduce the complications, which are prerequisites for frequent hospitalisations, are needed urgently. Vitamin D deficiency is common in children with SCA and is associated with recurrent vaso-occlusive crisis, blood transfusion, hospitalisation and infections. Routine vitamin D supplementation is not practiced in the care of sickle cell disease patients yet it has been associated with improved bone health and bone mineral density, reduced chronic pain and improved quality of life.
HYPOTHESIS
Vitamin D supplementation will lead to a lower incidence of hospitalisation than placebo in Ugandan children with SCA.
METHODS: The study will be a randomized, placebo-controlled, double blind clinical trial in which 331 Ugandan children with SCA aged 6 months to 12 years inclusive will receive vitamin D (60,000IU granules monthly) and another 331 a placebo (identical to vitaminD in appearance) for 3 months. The primary study outcome will be incidence of hospitalisation. Secondary outcomes will include incidence of vaso-occlusive crisis (VOC), acute severe respiratory illness, Vitamin D related Severe adverse events and requirements for blood transfusion IMPACT: If this trial shows a reduction in hospitalisation, it will be the basis for a multi-site pre-post intervention clinical trial to assess real-world safety and efficacy of Vitamin D in African children with SCA. The monthly administration is easy, and since vitamin D is inexpensive, this trial has the potential to improve the health of hundreds/ thousands of African children with SCA through reduction of infection-related morbidity and mortality.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
The sachets containing vitamin D will be exactly similar to the ones containing the placebo. Both the intervention and placebo granules will be identical in colour, odour, taste and amount. Children will be randomized into treatment groups by order of entry in the study, based on a pre-determined blinded randomization list created and managed by an independent statistician.
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
- •Documented sickle cell disease (HbSS supported by hemoglobin electrophoresis results) attending Mulago Hospital Sickle Cell Clinic)
- •Age range of 6 months to 12 years, inclusive, at the time of enrolment
- •Weight at least 5.0 kg at the time of enrolment
- •Willingness to comply with all study-related treatments, evaluations, and follow-up
排除标准
- •Known other chronic medical condition (e.g., HIV, malignancy, Renal & liver disease, active clinical tuberculosis)
- •Severe acute malnutrition determined by impaired growth parameters as defined by WHO weight for length/height less than -3SD.
- •Evidence of Vitamin D supplementation in the past one month (by prescription or drug sample)
结局指标
主要结局
Frequency of hospitalisation among children with SCD supplemented with vitamin D versus placebo.
时间窗: 3 months follow up
Number of children hospitalised during the follow up period and number of hospitalisations per child
Effect of vitamin supplementation on serum levels of 25 Hydroxyvitamin D levels in children with SCD
时间窗: 3 months follow up
Serum levels of 25 Hydroxyvitamin D
Frequency of blood transfusion among children supplemented with vitamin D versus Placebo in children with sickle cell anaemia
时间窗: 3 months follow up
The number of children requiring blood transfusion during follow up and the episodes per child
次要结局
- Incidence of acute severe respiratory illnesses(3 months follow up)
- Incidence of vaso-occlusive crises (VOC)(3 months follow up)
- Severe adverse events(3 months follow up)
研究者
College of Health Sciences
Professor
Makerere University