Is a Low Salt Diet and Low Sugar Content Necessary When Corticosteroid Treatment is Prescribed?
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- Cumulative number of clinical events recorded during the study, per randomization group
研究概览
简要总结
Few recommendations concerning the diet and dosage to be administered to patients treated with corticosteroids are established.
It therefore seems important to study prospectively the indication of a diet low in salt and sugar in patients undergoing corticosteroid therapy, to record side effects observed and to measure their frequency.
详细描述
In the French clinical patterns governing the prescription of corticosteroids, it is customary to prescribe a diet low in salt and low in sugar. This dietary prescription is based on the interest of any diet to prevent the occurrence of side effects of steroids such as hypertension, obesity, diabetes and congestive heart.
However, there is no specific dietary requirements in other European countries. This lack of recommendations is based on the fact that there is no evidence that a strict diet reduces the side effects of steroids on the one hand and secondly, that the quality of life of patients undergoing a diet low in salt and low in sugars affects their quality of life. In addition, no prospective study has helped to establish the frequency of side effects of corticosteroids depending on dose and duration of treatment.
The investigators therefore propose to study whether a diet intervention with low salt or low sugar during a prolonged corticosteroid treatment has any interest and effectively reduces the frequency and severity of side effects.
The investigators propose that all parameters being equal, to randomize the diet of patients started on steroids for a predictable period of 3 months minimum for a dose greater than 20 mg per day. One group will observe the low-salt diet, low in sugar and the other will follow a normal diet. The assessment will be made after 1 year, even if steroid treatment is continued beyond.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 盲法
- None
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
- 未提供
排除标准
- 未提供
结局指标
主要结局
Cumulative number of clinical events recorded during the study, per randomization group
时间窗: 24 months
Cumulative number of the following clinical events recorded during the study, per randomization group: * Weight gain between study entry and the end of it * Significant rise in blood pressure between study entry and the end of it * Development of diabetes requiring treatment, whether prescribed oral or injectable and defined by international criteria of fasting glucose\> 7 mmol / fasting twice or post prandial \> 11,1 mmol/l twice * Occurrence of heart failure
Observance of the diet low in salt and sugar will be estimated by patient questionnaire and diary
时间窗: 6 months
Tolerance of the diet low in salt and sugar will be estimated by patient questionnaire and diary
时间窗: 6 months
次要结局
- Sides effects of corticosteroids therapy(24 months)
- Impaired glucide metabolism(24 months)