Urinary calcium excretion after depot oral cholecalciferol in under five children with nutritional rickets.
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Change in Mean Urinary calcium: creatinine excretion in children following depot dose of oral cholecalciferol
研究概览
简要总结
This study is a single arm interventional study aimed at finding Urinary Calcium Excretion after Depot Oral Cholecalciferol in Under Five Children with Nutritional Rickets. Study will be conducted in Paediatric OPD/ward at Maulana Azad Medical College and associated Lok Nayak Hospital, Delhi.
Primary outcome is Change in Mean Urinary calcium: creatinine excretion in children following depot dose of oral cholecalciferol.
Secondary outcome is Association of urine calcium excretion with baseline serum calcium and 25(OH)D levels, dietary calcium intake, renal function
Resolution of hypercalciuria in children with raised urinary calcium
Cumulative vitamin D doses and urine calcium excretion.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 盲法
- None
入排标准
- 年龄范围
- 3.00 Month(s) 至 5.00 Year(s)（—）
- 性别
- All
入选标准
- •Children aged 3 to 59 months Born at term more than equal to 37 weeks of gestation).
- •Clinical features of rickets (skeletal or extraskeletal) with serum 25 hydroxy vitamin D less than 20 ng/mL.
排除标准
- •Chronic Kidney Disease , tubulopathies, or known kidney disorders Non Nutritional Rickets, such as rickets due to genetic disorders (e.g., hypophosphatemic rickets) or secondary to other metabolic conditions.
- •Any chronic Illness that may affect calcium or vitamin D metabolism, such as liver disease, malabsorption syndromes, or parathyroid disorders.
- •Use of Medications known to interfere with calcium or vitamin D metabolism (e.g., corticosteroids, anticonvulsants, glucocorticoids) in last three months.
结局指标
主要结局
Change in Mean Urinary calcium: creatinine excretion in children following depot dose of oral cholecalciferol
时间窗: At baseline and 2 weeks
次要结局
- 1 Association of urine calcium excretion with baseline serum calcium & 25 hydroxy vitamin D levels, dietary calcium intake, renal function(2 Resolution of hypercalciuria in children with raised urinary calcium)
研究者
Muskan Verma
Maulana Azad Medical College