NCT04270643已完成2 期
Trial of High-Dose Vitamin D in the Treatment of Complicated Severe Acute Malnutrition
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 259
- 试验地点
- 2
- 主要终点
- Mean weight-for-height/length z-score
研究概览
简要总结
This double-blind randomized placebo-controlled controlled trial will test the hypothesis that administration of high-dose oral vitamin D supplementation to children in Lahore, Pakistan, who are recovering from complicated severe acute malnutrition will safely accelerate weight gain (primary outcome) and enhance neurodevelopment, muscle mass accumulation, resolution of systemic inflammation and antimicrobial immune function (secondary outcomes).
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)
入排标准
- 年龄范围
- 6 Months 至 5 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Consent of parent / guardian
- •Age 6-59 months at enrolment
- •Diagnosis of complicated SAM at the point of hospital admission as defined by the World Health Organisation.
- •Medical team managing the child has made the decision to discharge the child from inpatient care
排除标准
- •Ingestion of a dose of vitamin D>200,000 IU (5 mg) in the last 3 months
- •Known diagnosis of primary hyperparathyroidism or sarcoidosis (i.e. conditions pre-disposing to vitamin D hypersensitivity)
- •Known neurodevelopmental disorder (e.g. cerebral palsy)
- •HIV infection
- •Taking anti-tuberculosis treatment
- •Inability to assess child's developmental status at baseline using the Malawi Development Assessment Tool
- •Signs of rickets
- •Corrected serum calcium concentration >2.65 mmol/L on blood sample taken during the current hospital admission
结局指标
主要结局
Mean weight-for-height/length z-score
时间窗: 2 months
次要结局
- Mean weight-for-age z-score(2 and 6 months)
- Mean monocyte count, full blood count(2 and 6 months)
- Mean mid-upper arm circumference(2 and 6 months)
- Mean change in overall and domain-specific (gross motor, fine motor, language and social) neurodevelopmental scores, Malawi Developmental Assessment Tool(2 and 6 months)
- Mean height/length-for-age z-score(2 and 6 months)
- Mean corpuscular volume, full blood count(2 and 6 months)
- Mean head circumference-for-age z-score(2 and 6 months)
- Mean fat-free mass index(2 and 6 months)
- Proportion of participants readmitted to hospital due to any cause(6 months)
- Mean weight-for-height/length z-score(6 months)
- Mean fat mass index(2 and 6 months)
- Proportion of participants experiencing relapse of severe acute malnutrition(6 months)
- Serum concentrations of albumin, C-reactive protein, 25-hydroxyvitamin D, total alkaline phosphatase, parathyroid hormone, ferritin and hepcidin(2 and 6 months)
- Mean corpuscular haemoglobin concentration, full blood count(2 and 6 months)
- Mean neutrophil count, full blood count(2 and 6 months)
- Mean lymphocyte count, full blood count(2 and 6 months)
- Faecal concentrations of inflammatory markers (myeloperoxidase, neopterin and alpha-1 antitrypsin)(2 and 6 months)
- Faecal microbiome composition(2 and 6 months)
- Incidence of serious adverse events(6 months)
- Incidence of adverse reactions(6 months)
- Antimicrobial immune function (concentrations of inflammatory mediators in supernatants of whole blood stimulated with lipo-polysaccharide, zymosan and heat-killed Salmonella typhi)(2 and 6 months)
- Mean haemoglobin concentration, full blood count(2 and 6 months)
- Proportion of participants dying(6 months)
研究者
研究点 (2)
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