Is a Diet Necessary When Corticosteroid Treatment is Prescribed? (Cortisel)
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.
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
|Official Title:||Is a Low Salt Diet and Low Sugar Content Necessary When Corticosteroid Treatment is Prescribed?|
- Cumulative number of clinical events recorded during the study, per randomization group [ Time Frame: 24 months ] [ Designated as safety issue: Yes ]
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
- Sides effects of corticosteroids therapy [ Time Frame: 24 months ] [ Designated as safety issue: Yes ]frequency of sides effects
- Impaired glucide metabolism [ Time Frame: 24 months ] [ Designated as safety issue: Yes ]
surveillance of creatininemia, urinary and serum electrolytes changes
- Glucose regulation change observed by blood glucose, insulin, QUICKI and OGTT tests performed at the beginning and the end of the study.
- Evaluation of the pancreatic beta cell function (HOMA-B%) estimated as Matthews et al., 1985 done.
|Study Start Date:||November 2011|
|Estimated Study Completion Date:||June 2015|
|Estimated Primary Completion Date:||November 2014 (Final data collection date for primary outcome measure)|
Experimental: Normal regimen
without special regimen for corticosteroid therapy
regimen normal in salt and sugar
Other Name: Regimen
Active Comparator: Standard arm
with diet low in salt and sugar
Other: Standard regimen
with diet low in salt and sugar
Other Name: Standard regimen
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01420133
|Paris, France, 75014|
|Principal Investigator:||Loic Guillevin, MD, PhD||Assistance Publique - Hôpitaux de Paris|
|Study Director:||Jessie Aouizerate, MD||Assistance Publique - Hôpitaux de Paris|