Is a Diet Necessary When Corticosteroid Treatment is Prescribed? (Cortisel)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier:
NCT01420133
First received: June 23, 2011
Last updated: January 2, 2014
Last verified: January 2014
  Purpose

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.


Condition Intervention
Autoimmune Diseases
Asthma
Other: Regimen
Other: Standard regimen

Study Type: Interventional
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?

Resource links provided by NLM:


Further study details as provided by Assistance Publique - Hôpitaux de Paris:

Primary Outcome Measures:
  • 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


Secondary Outcome Measures:
  • 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.


Estimated Enrollment: 170
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)
Arms Assigned Interventions
Experimental: Normal regimen
without special regimen for corticosteroid therapy
Other: Regimen
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

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01420133

Locations
France
Cochin Hospital
Paris, France, 75014
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
Investigators
Principal Investigator: Loic Guillevin, MD, PhD AP-HP
Study Director: Jessie Aouizerate, MD AP-HP
  More Information

No publications provided

Responsible Party: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT01420133     History of Changes
Other Study ID Numbers: K080906, AFSSAPS
Study First Received: June 23, 2011
Last Updated: January 2, 2014
Health Authority: France: Ministry of Health

Keywords provided by Assistance Publique - Hôpitaux de Paris:
Corticosteroids
Diet low in sugar and salt
Dermatological disease
Corticosteroids Allergy
3 Months

Additional relevant MeSH terms:
Asthma
Autoimmune Diseases
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases

ClinicalTrials.gov processed this record on July 31, 2014