Is a Diet Necessary When Corticosteroid Treatment is Prescribed?

Asthma Clinical Trial

— Cortisel  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01420133
• Other study ID #: K080906
• Secondary ID: AFSSAPS
• Status: Completed
• Phase: N/A
• First received: June 23, 2011
• Last updated: December 21, 2015
• Start date: November 2011
• Est. completion date: October 2015

Study information

• Verified date: December 2015
• Source: Assistance Publique - Hôpitaux de Paris
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: October 2015
• Est. primary completion date: October 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion criteria :

• Age > 18 years

• All patients for whom corticoids initially prescribed at a dose > 20 mg per 24 hours, during a period of 3 months minimum

• Corticotherapy should be prescribed per os and continuously. (Alternating doses of corticoids, sequential intramuscular or intravenous injection of corticoids are not allowed in this clinical trial)

• All diseases requiring corticotherapy may be subject to this clinical trial. The main pathologies will be systemic autoimmune diseases, asthma or chronic skin diseases justifying prolonged oral corticotherapy.

• Time between first corticoids delivery and randomization < 1 month

• Patient who gave his non-opposition

Note: Depending on their health condition, patient may receive one or more intravenous injections of methylprednisolone (until 3 injections), before the beginning of oral corticotherapy.

Exclusion criteria :

• Age < 18 years or whose disability warrants a guardianship

• All patients for whom corticoids prescribed <20 mg per 24 hours or for an expected period <3 months

• Intramuscular or intravenous sequential corticoids delivery, without associated per os corticoids.

• Any corticotherapies other than prednisone, prednisolone or methylprednisolone.

• Any corticotherapies with alternating doses

• Intravenous or intramuscular injection corticotherapy

• Patient who received corticoids at a dose >20 mg / day, during 3 last years

• Allergy, hypersensitivity or cons-indication to corticoids

• The existence of diabetes before corticotherapy, because pre-existing diabetes requires specific follow-up treatment, such as sugars restrictions

• Uncontrolled hypertension (SBP = 180mHg or DBP = 110mHg)

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Asthma
• Autoimmune Diseases

Intervention

Other:
• Regimen
regimen normal in salt and sugar
• Standard regimen
with diet low in salt and sugar

Locations

Country	Name	City	State
France	Cochin Hospital	Paris

Sponsors (1)

Lead Sponsor	Collaborator
Assistance Publique - Hôpitaux de Paris

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cumulative number of clinical events recorded during the study, per randomization group	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	24 months	Yes
Primary	Observance of the diet low in salt and sugar will be estimated by patient questionnaire and diary		12 months	No
Primary	Tolerance of the diet low in salt and sugar will be estimated by patient questionnaire and diary		12 months	Yes
Primary	Observance of the diet low in salt and sugar will be estimated by patient questionnaire and diary		6 months	No
Primary	Tolerance of the diet low in salt and sugar will be estimated by patient questionnaire and diary		6 months	Yes
Secondary	Sides effects of corticosteroids therapy	frequency of sides effects	24 months	Yes
Secondary	Impaired glucide metabolism	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.	24 months	Yes