NCT01420133

Is a Diet Necessary When Corticosteroid Treatment is Prescribed?

Is a Low Salt Diet and Low Sugar Content Necessary When Corticosteroid Treatment is Prescribed?

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 50 (actual)
• Sponsor: Assistance Publique - Hôpitaux de Paris · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Autoimmune Diseases
• Asthma

Interventions

Type	Name	Description
OTHER	Regimen	regimen normal in salt and sugar
OTHER	Standard regimen	with diet low in salt and sugar

Timeline

• Start date: 2011-11-01
• Primary completion: 2015-10-01
• Completion: 2015-10-01
• First posted: 2011-08-19
• Last updated: 2026-03-30

Locations

1 site across 1 country: France