Ignite Creation Date:
2024-10-25 @ 7:51 PM
Last Modification Date:
2024-10-26 @ 3:42 PM
Study NCT ID:
NCT06640309
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-10-11
Brief Title:
The Effect of Nicotinamide on the Clinical Outcome of Rheumatoid Arthritis Patients
Sponsor:
None
Organization:
None
Study Overview
Official Title:
The Effect of Nicotinamide on the Clinical Outcome of Rheumatoid Arthritis Patients
Status:
RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
NAMRA
Brief Summary:
A randomized controlled interventional study to evaluate the efficacy and safety of nicotinamide supplementation in rheumatoid arthritis patients receiving conventional synthetic disease modifying anti-rheumatic drugs
Detailed Description:
Study design
A prospective randomized controlled interventional parallel open label study
Patient randomization
All patients fulfilling the inclusion criteria will be randomly assigned by simple randomization into either nicotinamide group or control group as follows
Nicotinamide group consists of thirty-five patients who will receive nicotinamide 1000mg tablet once dailyin addition to their conventional therapy
Control group consists of thirty-five patients who will receive their conventional therapy only
Methodology
At baseline the following will be obtained through patients interview
1 Demographic data
2 Medical history and comorbidities
3 The disease activity identified through patients physical examination and serum C-Reactive Protein CRP levels as prerequisites for Disease Activity Score-28 DAS-28-CRP
4 The disease duration
5 Current medications history
Evaluation of the efficacy and safety of nicotinamide will be assessed at baseline and after three months through
1 Blood sampling will be collected from patients for serum CRP Erythrocyte sedimentation rate ESR and analysis of Interleukin-10 These samples will be directly centrifuged at 1000 x g for fifteen minutes and then plasma will be separated and collected in capped test tubes then will be stored at -80 C until analysis
Interleukin-10 serum level will be measured using an Enzyme Linked Immunosorbent Assay ELISA technique
2 Disease Activity will be calculated based on tender joint count TJC and swollen joint count SJC following the assessment of twenty-eight joints serum CRP level and the patients global health assessment PGA on a scale from zero to one hundred The score will be calculated using the following equation
DAS-28-CRP 056 TJC28 028 SJC28 036ln CRP 1 0014PGA 096
3 Patients QOL will be assessed by using the Health Assessment Questionnaire-Disability Index HAQ-DI
4 Patients will be educated about the side effects andor adverse effects of nicotinamide where safety and tolerability will be monitored by reporting the incidence of any side effect and or adverse effect such as stomach upset flatulence dizziness headache and rash
Blood samples will be collected for complete blood count CBC alanine transaminase ALT aspartate transaminase AST serum creatinine Scr levels analysis to monitor adverse effects of conventional synthetic disease-modified antirheumatic csDMARDs drugs and nicotinamide
A prospective randomized controlled interventional parallel open label study
Patient randomization
All patients fulfilling the inclusion criteria will be randomly assigned by simple randomization into either nicotinamide group or control group as follows
Nicotinamide group consists of thirty-five patients who will receive nicotinamide 1000mg tablet once dailyin addition to their conventional therapy
Control group consists of thirty-five patients who will receive their conventional therapy only
Methodology
At baseline the following will be obtained through patients interview
1 Demographic data
2 Medical history and comorbidities
3 The disease activity identified through patients physical examination and serum C-Reactive Protein CRP levels as prerequisites for Disease Activity Score-28 DAS-28-CRP
4 The disease duration
5 Current medications history
Evaluation of the efficacy and safety of nicotinamide will be assessed at baseline and after three months through
1 Blood sampling will be collected from patients for serum CRP Erythrocyte sedimentation rate ESR and analysis of Interleukin-10 These samples will be directly centrifuged at 1000 x g for fifteen minutes and then plasma will be separated and collected in capped test tubes then will be stored at -80 C until analysis
Interleukin-10 serum level will be measured using an Enzyme Linked Immunosorbent Assay ELISA technique
2 Disease Activity will be calculated based on tender joint count TJC and swollen joint count SJC following the assessment of twenty-eight joints serum CRP level and the patients global health assessment PGA on a scale from zero to one hundred The score will be calculated using the following equation
DAS-28-CRP 056 TJC28 028 SJC28 036ln CRP 1 0014PGA 096
3 Patients QOL will be assessed by using the Health Assessment Questionnaire-Disability Index HAQ-DI
4 Patients will be educated about the side effects andor adverse effects of nicotinamide where safety and tolerability will be monitored by reporting the incidence of any side effect and or adverse effect such as stomach upset flatulence dizziness headache and rash
Blood samples will be collected for complete blood count CBC alanine transaminase ALT aspartate transaminase AST serum creatinine Scr levels analysis to monitor adverse effects of conventional synthetic disease-modified antirheumatic csDMARDs drugs and nicotinamide
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None