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Preliminary Clinical Study of NMN Intervention in Mild Ulcerative Colitis
Plain-language guide to NCT06214078: not phased randomized trial of NAD+, 48 participants. Who took part, design and what was measured.
Key Facts
- Registry ID
- NCT06214078
- Phase
- not phased
- Status
- status unknown
- Start
- 2024-02-01
- Completion (planned or actual)
- 2025-03-01
- Participants
- 48 (estimated)
- Design
- randomized, quadruple-blind, treatment
- Conditions studied
- Ulcerative Colitis Chronic Mild
- Results posted
- not yet
What This Study Did, in Plain Language
What Was Tested
In this not phased trial, researchers set out to test NAD+.
The main question it aims to answer is Whether NMN can alleviate the intestinal pathology of UC patients, so as to play a role in UC treatment or adjuvant therapy.
Participants will be randomized into two groups, an NMN group or a placebo group.
It had two arms (groups): NMN group (experimental) and placebo group (placebo comparator).
Patients in this group will receive 1 placebo capsule orally twice daily for 8 weeks.
The registry classes the interventions as dietary supplement and other.
Who Took Part
The registry lists 48 planned participants were the target.
It was open to people of any sex aged from 18 years up to 75 years.
Healthy volunteers were not accepted; participants needed the condition being studied.
Examples of who could join: Age ≥18 years old, ≤75 years old;. Clinical diagnosis of mild active UC patients, the diagnosis standard reference inflammatory bowel disease diagnosis and treatment of the consensus of opinion 2018. Agreed to participate in this study, and sign the informed consent.
The full record lists 3 inclusion and 9 exclusion criteria; among the exclusions: patients with alt or ast more than 2 times the upper limit of normal, tbil more than 2 times the upper limit of normal;; the intestines or other parts have severely active infection patients need to use antibiotics or antiviral drugs;; crohn's disease and intestinal tuberculosis and other chronic intestinal infectious disease, intestinal malignant tumor patients;.
How the Study Was Run
It was run as a randomized, parallel-group and quadruple-blind study.
Because people in this NAD+ study were split into groups at random, differences between the groups are less likely to reflect who happened to join each one.
Groups ran in parallel: each of the participants stayed in one arm throughout.
Blinding on both sides kept the participants and researchers unaware of who received NAD+.
Those kept unaware of assignments: participant, care provider, investigator and outcomes assessor.
It started in 2024-02-01 with completion listed for 2025-03-01.
It ran at 1 site in China.
Its stated primary purpose is treatment.
What Was Measured
The main thing measured (primary outcome): Clinical response rate (time frame: 8 weeks).
It also tracked 4 secondary outcomes, for example Biomarker target attainment rate, clinical remission rate, Endoscopic remission rate and Histologic remission rate after 8 weeks of intervention.
What This Means in Plain Language
Put simply, this is a not phased, randomized trial of NAD+ in 48 people.
Its status is unknown; no results are posted to the registry yet, so nothing here describes outcomes.
More context: the NAD+ compound page, all human trials.
Our Notes on the Compound
NAD+: The coenzyme that accepts electrons at complex I.
Related Pages
Source: ClinicalTrials.gov record. This explanation is written by PeptideWhiz from the public record. For research and education only. Not medical advice; no dosing information is given.