Study design, ethical approval, and participants
ICH, high-density lipoprotein, hemoglobin/erythrocytes, coronavirus disease 2019
BLOOD, SECONDARY, CORONAVIRUS DISEASE 2019, RECRUITMENT
This multicenter, randomized, parallel, double-blinded, placebo-controlled, dose-dependent clinical trial on NMN supplementation at daily oral doses of 300 mg, 600 mg, and 900 mg for 60 days aimed to test the effect of NMN supplementation on blood NAD concentration (primary outcome), safety, tolerability, and clinical efficacy (secondary outcomes) of NMN supplementation.This clinical trial was conducted in accordance with the ethical principles laid down by Declaration of Helsinki (Taipei 2016), the principles of ICH Guidelines for Good Clinical Practice (GCP) (1997), and New Drugs and Clinical Trial Rules, 2019. The “Royal Ethics Committee, Pune, India” reviewed and approved the clinical trial protocol and informed consent form submitted by the two principal investigators (PI) of this trial. The conduct of trial-related activities commenced after the approval from the ethics committee. The “Royal Ethics Committee, Pune, India” is an independent ethics committee formed as per the “New Drugs and the Clinical Trials Rule 2019”. The ethics committee is duly registered with Drugs Controller General of India (DCGI) via number - ECIV45/Indt/MII/2013/RR-19. This trial was registered with ClinicalTrials.gov, NCT04823260 and Clinical Trial Registry - India, CTRI/2021/03/032421. The trial was monitored by ProRelix Services LLP, a clinical research organization (CRO), Pune, India.The trial was conducted at two clinic centers: Lotus Healthcare and Aesthetics Clinic, and Sunad Ayurved (both in Pune, India), with an experienced principal investigator (PI) at each site. Recruitment was facilitated by targeted advertisement to healthy volunteers from the PIs’ own databases and referrals of other physicians at the two centers. Each volunteer was firstly given trial information and signed an informed consent form (ICF) before screening. The screening process entailed demographic data (name, sex, date of birth, age, race, height, weight) and medical history. Physical examinations including general and systemic examinations and vital signs (blood pressure, pulse rate, respiration rate, systolic and diastolic pressure, and body temperature), electrocardiogram (ECG), and X-ray of chest were performed on each volunteer. All volunteers were symptomatically assessed for coronavirus disease 2019 (COVID-19). Blood and urinary samples were taken at the two clinical centers, stored, and transported to Suburban Diagnostics (Pune, India) by following standard operation procedure (SOP) according to good clinical practice (GCP). Suburban Diagnostics (Pune, India) conducted the clinical lab tests which included hematology [hemoglobin, hematocrit, white blood count (WBC) (total and differential), red blood cell count (RBC), platelet count, prothrombin time (PT), activated partial thromboplastin time (aPTT), mean corpuscular hemoglobin concentration (MCHC), and mean corpuscular volume (MCV)], clinical chemistry [blood glucose (random), serum triglyceride, low-density lipoprotein (LDL), high-density lipoprotein (HDL), total cholesterol, serum creatinine, urea, aspartate aminotransferase (AST), alanine aminotransferase (ALT), alkaline phosphatase, total bilirubin, sodium, blood urea nitrogen (BUN), glomerular filtration rate (GFR), uric acid, chloride, calcium, potassium, albumin, total proteins], and urinalysis (pH, specific gravity, protein, glucose, ketone bodies, leukocytes, nitrite, hemoglobin/erythrocytes, urobilinogen, and bilirubin). For female volunteers, urine pregnancy test was assessed.Inclusion criteria for participants were 40-65 years and healthy volunteers of both males and females, body mass index (BMI) between 18.5 and 35 kg/m