NCT03585829已完成4 期
Comparison of the Risk of Complications and the Quality of Life During Ramadan Fasting in Patients With Corticotrope Deficiency Treated Either by Hydrocortisone or by Prednisolone
University Tunis El Manar1 个研究点 分布在 1 个国家目标入组 53 人开始时间: 2018年5月17日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 53
- 试验地点
- 1
- 主要终点
- Occurence of complications
研究概览
简要总结
Selected patients will be randomised to either hydrocortisone or prednisolone. Each treatment period is of 14 days. Abnormal clinical symptoms, blood glucose and quality of life will be monitored.
详细描述
- Selection of the patients who meet the inclusion and non inclusion criteria.
- Detailed explanations about the study to the patients.
- Signature of the informed consent by the patients.
- Randomisation of the patients by drawing lots into two groups; group AB who will receive treatment A during 14 days (period 1) then treatment B during 14 days (period 2) and group BA who will receive treatment B during 14 days (period 1) then treatment A during 14 days (period 2).
- Each patient will receive a daily follow-up sheet, a quality of life questionnaire, a glucometer with test strips and the treatment in different bottles for each period of the study.
- The daily follow-up sheet concerns habits during Ramadan (eating, sleeping), the occurrence of complications and blood glucose monitoring. Daily blood glucose monitoring is requested at midday, before dinner and if a malaise occurs. A detailed questionnaire on abnormal symptoms that might occur during fasting have to be fulfilled for each malaise.
- Quality of life will be evaluated using AddiQol questionnaire translated in Tunisian dialect. Patients have to complete the questionnaire before the fasting month and at the end of each period of treatment.
- Treatment is presented in the form of capsules with the same colour and size. Patients have to take one capsule at dinner and one capsule at pre-dawn meal. Patients will receive either hydrocortisone 15mg at pre-dawn meal and 5mg at dinner (sunset) (treatment A) or prednisolone 5mg at pre-dawn meal and a placebo (starch) at dinner (treatment B).
- During the study, patients will be in regular phone contact with a responsible of the study for any information or problem.
- At the end of the study, the completed follow-up sheets and questionnaires will be picked up.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Double (Participant, Care Provider)
盲法说明
the treatment has been put in capsules with the same size and color
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Known corticotrope deficiency treated by 20mg hydrocortisone per day.
- •Age: 18-70 years
- •patients who are willing to fast Ramadan 2018 and who voluntary accept to participate in the study.
- •Non inclusion criteria:
- •Patients with either diabetes mellitus, hypertension, diabetes insipidus, severe organ damage (renal, cardiac, pulmonary, hepatic), neoplasia, psychiatric disease, epilepsy or pregnant or breast-feeding women.
排除标准
- •The occurrence of any of the non inclusion criteria during the study. The occurrence of a severe malaise.
研究组 & 干预措施
hydrocortisone
Active Comparator
hydrocortisone 20 mg per day: 15 mg at pre-dawn meal and 5 mg at dinner
干预措施: Hydrocortisone (Drug)
prednisolone
Active Comparator
Prednisolone 5 mg at pre-dawn meal and a placebo (starch) at dinner
干预措施: Prednisolone (Drug)
结局指标
主要结局
Occurence of complications
时间窗: during the fourteen days treatment period
fatigue, asthenia, symptoms of hypoglycemia, symptoms of dehydration, hypoglycemia on blood glucose monitoring
次要结局
- score of quality of life(during the fourteen days treatment period)
研究者
Melika Chihaoui
Principal investigator
University Tunis El Manar
研究点 (1)
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