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Nicotinamide Riboside for Systemic Lupus Erythematosus (SLE)

Phase 1 & 2

Recruiting

Led By Michael N Sack, M.D.

Research Sponsored by National Heart, Lung, and Blood Institute (NHLBI)

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

No history of autoimmune or inflammatory disease;

If on glucocorticoids, the dose must be less than or equal to 20 mg daily and stable for at least 4 weeks prior to screening;

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 4 years

Awards & highlights

Study Summary

This trial will assess the effect of NR on blunting type 1 IFN signaling and bioenergetic/immunometabolic profiles in SLE women to modulate metabolic pathways and endothelial dysfunction.

Who is the study for?

This trial is for women over 18 with mild to moderate Systemic Lupus Erythematosus (SLE), meeting specific criteria, and not on certain immunosuppressive drugs or recent biologic agents. They must have stable medication doses, agree to effective birth control, and commit to the study's duration without major organ dysfunction.Check my eligibility

What is being tested?

The trial tests if Nicotinamide Riboside (NR) can improve immune system metabolism in SLE by boosting NAD+ levels. It compares NR's effects on inflammatory responses and energy production in cells against a placebo over a period of up to 12 weeks.See study design

What are the potential side effects?

Potential side effects are not detailed here but may include typical reactions associated with dietary supplements such as digestive discomfort or skin flushing due to increased NAD+ levels.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have never had an autoimmune or inflammatory disease.

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I have been on a stable dose of glucocorticoids (20 mg or less daily) for at least 4 weeks.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 4 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~4 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and 4 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

The primary end point will be to assess the effect of NR on blunting type I IFN signaling and cytokine secretion from placebo vs. NR supplemented subjects in monocytes comparing baseline (visit 1 to visit 3).

Trial Design

3Treatment groups

Active Control

Placebo Group

Group I: Healthy controlsActive Control1 Intervention

This group will not receive the dietary supplement or placebo.

Group II: Subjects with SLE - ActiveActive Control1 Intervention

This study group will take the dietary supplement Nicotinamide Riboside capsules.

Group III: Subjects with SLE - PlaceboPlacebo Group1 Intervention

This study group will take the Placebo.

0 / 2Eligibility criteria met

Find a Location

Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

National Heart, Lung, and Blood Institute (NHLBI)Lead Sponsor

3,840 Previous Clinical Trials

47,852,046 Total Patients Enrolled

Michael N Sack, M.D.Principal InvestigatorNational Heart, Lung, and Blood Institute (NHLBI)

13 Previous Clinical Trials

9,160 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is the eligibility criterion for this trial restricted to those who are younger than 25?

"This trial is open to individuals of legal age or older and who are younger than a century."

Answered by AI

Is this experimental protocol currently recruiting participants?

"According to the clinicaltrials.gov website, this particular trial is not currently enrolling patients. This study had originally been posted on September 28th, 2023 and was last edited nearly a month later; however, 151 other trials are open for participants at this time."

Answered by AI

Is enrollment for this clinical inquiry open to the general public?

"The trial is recruiting 78 individuals of ages between 18 and 120 with systemic lupus erythematosus. It is crucial that these candidates have no prior history of autoimmune or inflammatory diseases for their application to be considered."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Double-blind Placebo Controlled Study to Evaluate the Effect of NAD+ Boosting With Nicotinamide Riboside on Immunometabolism and Immunity in Systemic Lupus Erythematosus

2024. "Double-blind Placebo Controlled Study to Evaluate the Effect of NAD+ Boosting With Nicotinamide Riboside on Immunometabolism and Immunity in Systemic Lupus Erythematosus". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06032923.

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