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Completed

NCT Number: NCT01420133

Is a Diet Necessary When Corticosteroid Treatment is Prescribed?

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Cochin Hospital

Paris, 75014, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Regimen

Other

regimen normal in salt and sugar

Standard regimen

Other

with diet low in salt and sugar

Primary outcomes

  1. Cumulative number of clinical events recorded during the study, per randomization group

    Time frame: 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
  2. Observance of the diet low in salt and sugar will be estimated by patient questionnaire and diary

    Time frame: 12 months

  3. Tolerance of the diet low in salt and sugar will be estimated by patient questionnaire and diary

    Time frame: 12 months

  4. Observance of the diet low in salt and sugar will be estimated by patient questionnaire and diary

    Time frame: 6 months

  5. Tolerance of the diet low in salt and sugar will be estimated by patient questionnaire and diary

    Time frame: 6 months

Secondary outcomes

  1. Sides effects of corticosteroids therapy

    Time frame: 24 months

    frequency of sides effects

  2. Impaired glucide metabolism

    Time frame: 24 months

    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.

Sponsors and collaborators

Lead sponsor

Assistance Publique - Hôpitaux de Paris

Other

Collaborators

  • URC-CIC Paris Descartes Necker Cochin

Registry information

Official study title

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

Acronym: Cortisel

Important dates

Study start
2011
Primary completion
2015
Study completion
2015
First posted
Aug 19, 2011
Registry last updated
Mar 30, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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