M08.99
Conditions
Interventions
Group 1: Whole Food plant-based nutrition for 3 months, followed by any desired diet for another 3 months until the end of the study.
Group 2: Usual diet for 3 months, followed by a whole food plant-b
Sponsors
Klinik für Pädiatrie m. S. Onkologie/Hämatologie/SZTAG Integrative Medizin/SeifertCharité Universitätsmedizin Berlin
Eligibility
Sex/Gender
All
Age
8 Years to 18 Years
Inclusion criteria
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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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. 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
| Measure | Time frame |
|---|---|
| - Change in general well-being and pain, assessed by the patient or the parents using a visual analog scale from 0-10 (VAS) after 12 and 24 weeks. - Change in disease activity (assessed using JADAS-10, a validated JIA activity score, sum of the individual components global disease activity assessment by doctor (VAS), assessment of general well-being by patient / parents (VAS), number of active joints, CRP or ESR) after 12 and 24 weeks. - Number of patients with a disease flare after 24 weeks - Number of patients with pain medication as concomitant therapy after 6, 12, and 24 weeks - Change in fatigue (assessed using VAS) and quality of life (determined using the Pediatric Quality of Life Inventory (PedsQL) after 12 and 24 weeks. - Evaluation of the diet adherence by means of the VAS answer to the question: "How well has the change in diet been implemented?" After 12 and 24 weeks; - Evaluation of the diet adherence by means of information in a nutrition questionnaire after 6, 12 and 24 weeks; - Evaluation of the diet composition by means of information in a 72-hours food diary after 12 and 24 weeks; - Laboratory chemical evaluation of diet adherence by determining the carotenoids in the plasma and polyphenols in the urine after 12 and 24 weeks; - Assessment of the supply of critical nutrients by determining holotranscobalamin, methylmalonic acid, homocysteine, ferritin, transferrin saturation, selenium and zinc in the blood, iodine in the urine after 12 and 24 weeks; - Change in the composition and functionality of the oral and intestinal microbiome after 12 and 24 weeks; - Experimental: changes in immunological, metabolic and inflammatory processes; | — |
Countries
Germany
Contacts
Public ContactGonza Ngoumou
Klinik für Pädiatrie m. S. Onkologie/Hämatologie/SZTAG Integrative Medizin/Seifert
Outcome results
None listed