A study to investigate Vitamin B3 concentrations in the joint after intake

Assessing penetration of high dose Nicotinamide (Vitamin B3) in synovial fluid - B-Vit in the joint

Status

Not yet recruiting

Phases

Phase 1Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2018-002245-11-NL

Enrollment

Registered

2018-08-20

Start date

2019-01-16

Completion date

Unknown

Last updated

2019-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Juvenile Idiopathic Arthritis (JIA)

Interventions

Product Name: nicotinamide Product Code: 98-92-0 Pharmaceutical Form: Tablet INN or Proposed INN: NICOTINAMIDE Other descriptive name: V

Eligibility

Sex/Gender

All

Inclusion criteria

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 of 16 years or older and under treatment of the pediatric rheumatology department of the WKZ/UMC Utrecht. Are the trial subjects under 18? yes Number of subjects for this age range: 6 F.1.2 Adults (18-64 years) no F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: - No informed consent possible by patient - Inability to take oral medication - Participation in other interventional trials

Design outcomes

Primary

Measure	Time frame
Main Objective: NAM, well known as a dietary supplement, has also been extensively studied in humans in a variety of diseases in both children and adults. However, the bioavailability of NAM in patients with JIA at the side of inflammation, and therefore it’s potential as a therapeutic agent, is yet unknown. The primary objective of this study is therefore to assess the penetration of orally ingested NAM in the synovial fluid. In this phase II trial essential preliminary information will be gained on the peak NAM levels in the synovial fluid. ;Secondary Objective: not applicable;Primary end point(s): Penetration of nicotinamide in the synovial fluid. Adequate penetration is defined as a nicotinamide level in the synovial fluid of at least 10% of the peak plasma level. ;Timepoint(s) of evaluation of this end point: 3 days	—

Measure

Time frame

Main Objective: NAM, well known as a dietary supplement, has also been extensively studied in humans in a variety of diseases in both children and adults. However, the bioavailability of NAM in patients with JIA at the side of inflammation, and therefore it’s potential as a therapeutic agent, is yet unknown. The primary objective of this study is therefore to assess the penetration of orally ingested NAM in the synovial fluid. In this phase II trial essential preliminary information will be gained on the peak NAM levels in the synovial fluid. ;Secondary Objective: not applicable;Primary end point(s): Penetration of nicotinamide in the synovial fluid. Adequate penetration is defined as a nicotinamide level in the synovial fluid of at least 10% of the peak plasma level. ;Timepoint(s) of evaluation of this end point: 3 days

—

Secondary

Measure	Time frame
Secondary end point(s): none;Timepoint(s) of evaluation of this end point: not applicable	—

Countries

Netherlands

Contacts

Public ContactS.J.Vastert

UMC utrecht

b.vastert@umcutrecht.nl0031887554339

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026