Vitamin D and Calcium Supplementation to Prevent Post-total Thyroidectomy Hypocalcaemia, a Comparative Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 86
- 试验地点
- 2
- 主要终点
- number of participants with hypocalcemia
研究概览
简要总结
two groups of patients undergoing total thyroidectomy one group received calcium and vit d prophylaxis the other group received no prophylaxis the investigator measured calcium level post and preoperative and development of tetant was recorded
详细描述
This study is randomized controlled trial carried out on 86 patients undergoing total thyroidectomy in the period between January 2018 and November 2019. Patients were randomly allocated into two groups each one 43 patients the first group is the supplementation group where patients received oral vitamin D 40000 IU and calcium tablets 1 g once before surgery.
Patient included in this study are those above 18 years old undergoing total thyroidectomy.
Patients excluded from this study are those with
- Previous thyroid surgery
- Malabsorption diseases
- Pregnancy
- Previous parathyroid disease or surgery
- Vitamin D deficiency
- Renal impairment
- Hypo or hyper calcaemia
- ASA class 3,4
all patients in this study were subjected to thorough history taking full clinical examination, body mass index calculation, proper assessment of the original thyroid disease requiring surgery, preoperative investigations done as usual in addition to serum calcium, serum magnesium, serum vitamin D and serum parathormon level.
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
- Single (Participant)
盲法说明
the patients dont know what they received before the operation
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •patient undergoing total thyroidectomy
排除标准
- •Previous thyroid surgery
- •Malabsorption diseases
- •Pregnancy
- •Previous parathyroid disease or surgery
- •Vitamin D deficiency
- •Renal impairment
- •Hypo or hyper calcaemia
- •ASA class 3,4
结局指标
主要结局
number of participants with hypocalcemia
时间窗: 24 hrs post operative
calcium level below 8.5 mg\\dl measured by serum calcium assay
number of participants with hypocalcaemia
时间窗: after 7 days post operative
calcium level below 8.5 mg\\dl measured by serum calcium assay
次要结局
- number of participants with decreased parathormone level below normal level(( 1st month post operative))
- number of participants with tetany(1 week)
研究者
Hazem Nour Abdellatif
Assistant professor
Zagazig University