Evaluate the Efficacy and Safety of Uthever NMN(Nicotinamide Mononucleotide, a Form of Vitamin B3) (NMN)
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ClinicalTrials.gov Identifier: NCT04228640 |
Recruitment Status :
Completed
First Posted : January 14, 2020
Last Update Posted : April 1, 2021
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Tracking Information | |||||
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First Submitted Date ICMJE | January 9, 2020 | ||||
First Posted Date ICMJE | January 14, 2020 | ||||
Last Update Posted Date | April 1, 2021 | ||||
Actual Study Start Date ICMJE | December 15, 2020 | ||||
Actual Primary Completion Date | February 27, 2021 (Final data collection date for primary outcome measure) | ||||
Current Primary Outcome Measures ICMJE |
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Original Primary Outcome Measures ICMJE | Same as current | ||||
Change History | |||||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE | Same as current | ||||
Current Other Pre-specified Outcome Measures |
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Original Other Pre-specified Outcome Measures | Same as current | ||||
Descriptive Information | |||||
Brief Title ICMJE | Evaluate the Efficacy and Safety of Uthever NMN(Nicotinamide Mononucleotide, a Form of Vitamin B3) | ||||
Official Title ICMJE | A Multicentre, Randomized, Double Blind, Parallel Design, Placebo Controlled Study to Evaluate the Efficacy and Safety of Uthever (NMN), an Orally Administered Supplementation in Middle Aged and Older Adults. | ||||
Brief Summary | This will be a multi-center, two arm study in 66 healthy adults. Subjects will complete a screening visit (V1, Day -7) to determine eligibility for the study based on Inclusion & Exclusion Criteria, patient history and safety measures. Eligibility confirmation will be done on visit 2 (Day 1). Patients successfully completing screen will be assigned to either of the two treatments. Subjects will receive the treatment for at-home use and will also be given diaries for recording information of medication, and adverse events. At 2 different intervals i.e. Day 30 and Day 60 (V3, V4) subjects will return to the clinic to review and collect patient diaries, safety data and medication reconciliation. Efficacy and safety assessments will be done at baseline, Day 30 and Day 60 . | ||||
Detailed Description | Sixty-six healthy male or female middle-aged or older subjects will be assigned in 1:1 ratio to treatment with the test product, NMN or Placebo in this double-blind, randomized, placebo-controlled study. All 66 enrolled subjects will be instructed to take two capsules of either NMN or Placebo once a day after breakfast for 60 days daily. Subjects will be required to use diaries to document the date and time of study treatments including any missed doses and the occurrence of any adverse events. The duration of each subject's participation in the study will be of 60 days. Scheduled study visits will include:
During Visit 1 (Screening), informed consent will be obtained before any study procedures take place. After subject has been consented, medical history will then be documented, including the concomitant medications (if any). Physical examination and ECG will be carried out for all subjects. Subjects' vital signs will be recorded along with pulse pressure (PP).Their laboratory investigations like Hematology, Clinical chemistry and Urinalysis will be done. They shall undergo the screening procedure by inclusion and exclusion criteria. Subject's demography data will be collected. They will be given instructions for the next visit. At Visit 2 (Day 1, Baseline visit), eligibility confirmation will be done, and each enrolled subject will be randomly assigned in double-blind fashion, in 1:1 ratio to the test product or the Placebo. Blinded investigational product will be dispensed to subjects who meet all the inclusion and none of the exclusion criteria. Subjects will be instructed to take two capsules of the either placebo or NMN once a day with ambient temperature water after breakfast. They shall be recording the dosing details in subject diaries. The first dose of Investigational Product will be taken by the subject at home. Subjects will be evaluated through SF-36 questionnaire for their health. They will be required to answer few questions pertaining to their health. (PI, CRC or site staff will fill SF-36 questionnaire in visit 2, 3 and 4 by asking the subject). All the baseline assessments for efficacy will be performed. At visit 3 (Day 30) and visit 4 (Day 60), subjects will return to the clinic to review and collect subjects' diaries, safety data, and medication reconciliation. Efficacy and safety assessments will be done at both the visits. Subjects will be asked to bring their subject diaries and used/unused Investigational Products every time they visit the site. Enough quantity of Investigational Product will be dispensed every visit. Subjects' vital signs will be recorded along with pulse pressure (PP) at all visits. Adverse event assessment and concomitant assessment will be done at each visit along with compliance with drug applications. |
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Study Type ICMJE | Interventional | ||||
Study Phase ICMJE | Not Applicable | ||||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Intervention Model Description: A Multicenter, Randomized, Double-Blind, Placebo-Controlled Masking: Double (Participant, Investigator)Masking Description: Randomized, Double-Blind Primary Purpose: Prevention
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Condition ICMJE | Aging | ||||
Intervention ICMJE |
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Study Arms ICMJE |
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Publications * | Huang H. A Multicentre, Randomised, Double Blind, Parallel Design, Placebo Controlled Study to Evaluate the Efficacy and Safety of Uthever (NMN Supplement), an Orally Administered Supplementation in Middle Aged and Older Adults. Front Aging. 2022 May 5;3:851698. doi: 10.3389/fragi.2022.851698. eCollection 2022. | ||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||
Recruitment Status ICMJE | Completed | ||||
Actual Enrollment ICMJE |
66 | ||||
Original Estimated Enrollment ICMJE | Same as current | ||||
Actual Study Completion Date ICMJE | March 30, 2021 | ||||
Actual Primary Completion Date | February 27, 2021 (Final data collection date for primary outcome measure) | ||||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 40 Years to 65 Years (Adult, Older Adult) | ||||
Accepts Healthy Volunteers ICMJE | Yes | ||||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
Listed Location Countries ICMJE | India | ||||
Removed Location Countries | |||||
Administrative Information | |||||
NCT Number ICMJE | NCT04228640 | ||||
Other Study ID Numbers ICMJE | EFFE-CT-01 | ||||
Has Data Monitoring Committee | No | ||||
U.S. FDA-regulated Product |
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IPD Sharing Statement ICMJE |
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Current Responsible Party | EffePharm LTD | ||||
Original Responsible Party | Same as current | ||||
Current Study Sponsor ICMJE | EffePharm LTD | ||||
Original Study Sponsor ICMJE | Same as current | ||||
Collaborators ICMJE | ProRelix Services LLP | ||||
Investigators ICMJE |
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PRS Account | EffePharm LTD | ||||
Verification Date | March 2021 | ||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |