A whole food plant-based diet accompanying therapy in juvenile idiopathic arthritis - a pilot study on feasibility
Not Applicable
- Conditions
- M08.99
- Registration Number
- DRKS00023746
- Lead Sponsor
- Klinik für Pädiatrie m. S. Onkologie/Hämatologie/SZTAG Integrative Medizin/SeifertCharité Universitätsmedizin Berlin
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- All
- Target Recruitment
- 30
Inclusion Criteria
Diagnosis of juvenile idiopathic arthritis;
- No joint puncture or therapy intensification in the last 3 months;
- Ages between 8 and 18 years;
- Written consent of the patient or the legal representative to participate in the present study and for the transfer of pseudonymised data as part of the documentation and Analysis.
Exclusion Criteria
- Psychiatric pre / concomitant diseases (especially eating disorders);
- BMI <10th age related percentile;
- presence of a metabolic disease;
- Other existing serious illnesses that could impair treatment of the patient in accordance with the study plan
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The aim of the study is to investigate the feasibility and to determine first estimates of the possible effect of an anti-inflammatory, whole food plant-based diet accompanying drug therapy for juvenile idiopathic arthritis (JIA). In addition, data should be generated to create the basis for sample size planning and an evaluation with regard to possible suitable target values ??for a follow-up project.<br><br>Due to the exploratory nature of this study, no primary and further secondary endpoints are defined. Equivalent hypotheses and target variables are defined, which focus on the feasibility and are used to determine first estimates of a possible effect of an anti-inflammatory whole food plant-based diet.
- Secondary Outcome Measures
Name Time Method