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van CCT (UK)

van CCT (UK)

A study to investigate the safety of additional treatment with Vitamin B3 in children with Juvenile Idiopathic Arthritis (JIA)

- candidate number27547
- NTR NumberNTR6567
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR13-jul-2017
- Secondary IDsEudraCT number 2016-003643-10
- Public TitleA study to investigate the safety of additional treatment with Vitamin B3 in children with Juvenile Idiopathic Arthritis (JIA)
- Scientific TitleModulating regulatory T cell function in JIA with Vitamin B3 (nicotinamide) treatment
- ACRONYMB-Vit in JIA trial
- hypothesisWe envision that maintenance treatment with nicotinamide, when combined with established immunosuppressive treatment, will help to regain immunological balance in children with JIA. It can therefore have an important role in tapering and stop strategies of immunosuppressive treatments in JIA.
- Healt Condition(s) or Problem(s) studiedJuvenile idiopathic arthritis (JIA), Juvenile rheumatoid arthritis
- Inclusion criteria- Patients with a diagnosis of oligo-articular or poly-articular JIA with active disease in 1 or multiple joints and an indication for intra-articular corticosteroid injection.
- Age between 4 to 18 years
- At the moment of inclusion, not on non-biological DMARD (Methotrexate) treatment or on stable DMARD treatment (at least 3 months of stable Methotrexate use).
- Exclusion criteria- no informed consent possible by patient/parents or caregivers
- participation in other interventional trials
- Treatment with biological DMARD
- Recently started treatment with non-biological DMARD (Methotrexate). Defined as treatment for a period less than 3 months.
- Use of systemic corticosteroids
- Relevant co morbidity: raised liver enzymes (>2x upper limit) and/or evidence of bone marrow failure (pancytopenia based upon full blood count).
- mec approval receivedno
- multicenter trialno
- randomisedno
- groupParallel
- Type2 or more arms, non-randomized
- Studytypeintervention
- planned startdate 1-sep-2017
- planned closingdate1-mrt-2020
- Target number of participants30
- InterventionsAdditional nicotinamide treatment with 1,2g/m2/day or 1,8g/m2/day in either 2 or 3 doses a day for the duration of 3 months
- Primary outcomesafety, feasibility and tolerability of nicotinamide treatment
- Secondary outcome- PK/PD data
- to acquire preliminary data on the effect of nicotinamide on the function of regulatory T cells in vivo and in vitro by using surrogate parameters.
- Timepoints2 weeks, 6 weeks, 3 months and 6 months after start of treatment
- Trial web site
- statusplanned
- Sponsor/Initiator University Medical Center Utrecht (UMCU)
- Funding
(Source(s) of Monetary or Material Support)
WKZ research Fund
- Publications
- Brief summaryIn JIA there is a distortion in immunological balance between regulatory T cells (Treg) and effector T cells (Teff). Enhancing the suppressive function of regulatory T cells and thereby restoring this balance is therefore a promising novel therapeutic strategy. Current treatment, like DMARDS and biologicals, however focuses primarily on influencing effector T cells. Interestingly, in the past few years it was found that Vitamin B3, also known as nicotinamide (NAM) stabilizes FOXP3 expression via inhibition of the histone deacetylase SIRT1. Through this mechanism it has the potential to beneficially affect this immunological balance by positively influencing regulatory T cell function. In addition to the effect on regulatory T cells, NAM showed to have a down regulating effect on CD4+ and CD8+ cells and could therefore influence both sides of the equation. We envision that NAM maintenance treatment, when combined with established immunosuppressive treatment, could help restore the immunological balance and hereby contribute to gaining and maintaining remission in JIA patients. However, although NAM is well known as a dietary supplement and has been extensively studied in humans in a variety of diseases, the safety and tolerability of NAM in children with JIA is yet unknown. The primary objective of this study is therefore to assess safety, feasibility and tolerability of NAM in the proposed dose in children with JIA.
- Main changes (audit trail)
- RECORD13-jul-2017 - 31-aug-2017

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