Autoimmune DiseasesCortiselNCT01420133
Is a Diet Necessary When Corticosteroid Treatment is Prescribed?
A study testing Regimen and Standard regimen in people with Autoimmune Diseases and Asthma, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Autoimmune Diseases, Asthma
- What is being tested?
- Regimen and Standard regimen
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteFrance
- Study dates
- Nov 2011to Oct 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
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- 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)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Is a Low Salt Diet and Low Sugar Content 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.
Read the 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
- Being tested
- Regimen, Standard regimen
- Keywords
- Corticosteroids, Diet low in sugar and salt, Dermatological disease, Corticosteroids Allergy, 3 Months
- Medical subject headings
- Autoimmune Diseases, Asthma, Skin Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RegimenOther
regimen normal in salt and sugar
Standard regimenOther
with diet low in salt and sugar
| Study group | Role | What they receive |
|---|---|---|
| Normal regimen | Experimental | without special regimen for corticosteroid therapy Receives: Other: Regimen |
| Standard arm | Active comparator | with diet low in salt and sugar Receives: Other: Standard regimen |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 24 months
Observance of the diet low in salt and sugar will be estimated by patient questionnaire and diary
Measured: 12 months
Tolerance of the diet low in salt and sugar will be estimated by patient questionnaire and diary
Measured: 12 months
Observance of the diet low in salt and sugar will be estimated by patient questionnaire and diary
Measured: 6 months
Tolerance of the diet low in salt and sugar will be estimated by patient questionnaire and diary
Measured: 6 months
Secondary outcomes (2)
Sides effects of corticosteroids therapy
frequency of sides effects
Measured: 24 months
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.
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Aug 2011 (estimated)
- Study startNov 2011
- Primary completionOct 2015
- Study completionOct 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Autoimmune DiseasesStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Collaborators
- URC-CIC Paris Descartes Necker Cochin
- Responsible party
- Sponsor
- Investigators
- Loic Guillevin, MD, PhD, Principal investigator, Assistance Publique - Hôpitaux de ParisJessie Aouizerate, MD, Study director, Assistance Publique - Hôpitaux de Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01420133
- Sponsor's protocol ID
- K080906
- Other IDs
- AFSSAPS
- Acronym
- Cortisel
- Status last verified
- Mar 2026
- First submitted
- 23 Jun 2011
- Last updated
- 30 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 30 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Is a Low Salt Diet and Low Sugar Content Necessary When Corticosteroid Treatment is Prescribed?
- ClinicalTrials.gov ID
- NCT01420133
- Acronym / sponsor ID
- Cortisel / K080906
- Conditions
- Autoimmune Diseases, Asthma
- Keywords
- Corticosteroids, Diet low in sugar and salt, Dermatological disease, Corticosteroids Allergy, 3 Months
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Collaborators
- URC-CIC Paris Descartes Necker Cochin
- Study start
- Nov 2011
- Primary completion
- Oct 2015 (actual)
- Study completion
- Oct 2015 (actual)
- First posted
- 19 Aug 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Normal regimen | Experimental | Other: Regimenwithout special regimen for corticosteroid therapy |
| Standard arm | Active comparator | Other: Standard regimenwith diet low in salt and sugar |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Regimenregimen normal in salt and sugar | Other | Normal regimen |
| Standard regimenwith diet low in salt and sugar | Other | Standard arm |
Primary outcome
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
Observance of the diet low in salt and sugar will be estimated by patient questionnaire and diary
Time frame: 12 months
Tolerance of the diet low in salt and sugar will be estimated by patient questionnaire and diary
Time frame: 12 months
Observance of the diet low in salt and sugar will be estimated by patient questionnaire and diary
Time frame: 6 months
Tolerance of the diet low in salt and sugar will be estimated by patient questionnaire and diary
Time frame: 6 months
2 secondary outcomes
Sides effects of corticosteroids therapy
Time frame: 24 months
Impaired glucide metabolism
Time frame: 24 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Mar 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Loic Guillevin, MD, PhD principal investigator
Assistance Publique - Hôpitaux de Paris
Jessie Aouizerate, MD study director
Assistance Publique - Hôpitaux de Paris
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Regimen and Standard regimen in people with Autoimmune Diseases and Asthma, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cumulative number of clinical events recorded during the study, per randomization group (time frame: 24 months). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Mar 2026.