Ignite Creation Date:
2025-12-25 @ 3:46 AM
Ignite Modification Date:
2026-03-01 @ 6:11 AM
Study NCT ID:
NCT06465602
Status:
RECRUITING
Last Update Posted:
2024-06-20
First Post:
2024-06-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Nicotinamide Supplementation Improves Physical Performance in Older Adults at Risk of Falls
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000073496', 'term': 'Frailty'}, {'id': 'D009043', 'term': 'Motor Activity'}], 'ancestors': [{'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D001519', 'term': 'Behavior'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D009536', 'term': 'Niacinamide'}], 'ancestors': [{'id': 'D009539', 'term': 'Nicotinic Acids'}, {'id': 'D000147', 'term': 'Acids, Heterocyclic'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D011725', 'term': 'Pyridines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'OUTCOMES_ASSESSOR'], 'maskingDescription': "Patients will be assigned to either Nicotinamide or placebo through block allocation. One researcher will be responsible for patient recruitment via telephone and obtaining informed consent. Another researcher will perform patient randomization and drug dispensing. Physiotherapists conducting both the initial and final physical assessments and those conducting rehabilitation sessions will be blinded to the patient's assigned group."}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Pilot randomized clinical trial, block allocation, double-blind'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-05-21', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-04', 'completionDateStruct': {'date': '2025-02-28', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-06-13', 'studyFirstSubmitDate': '2024-06-13', 'studyFirstSubmitQcDate': '2024-06-13', 'lastUpdatePostDateStruct': {'date': '2024-06-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-06-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-11-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Improvement in physical performance', 'timeFrame': 'Four weeks', 'description': 'Assess the change in total Short Physical Performance Battery (SPPB) performance from baseline to post-4 weeks'}], 'secondaryOutcomes': [{'measure': 'Posturography', 'timeFrame': 'Four weeks', 'description': 'Change Center of pressure (COP) between baseline and post-training in posturography'}, {'measure': 'Dynamometry', 'timeFrame': 'Four weeks', 'description': 'Change in dynamometry performance between baseline and post-training'}, {'measure': 'Quadriceps saturation', 'timeFrame': 'Four weeks', 'description': 'Change in quadriceps saturation after a 5-squat test'}, {'measure': 'Adherence to medication', 'timeFrame': 'Four weeks', 'description': 'Nicotinamide/placebo usage via self-report survey'}, {'measure': 'Adverse effects', 'timeFrame': 'Four weeks', 'description': 'Assessment of adverse effects using a standardized evaluation guideline.'}, {'measure': 'Plasma sample analysis', 'timeFrame': 'Four weeks', 'description': 'Nicotinamide leves, Interleukin-13 (IL-13), Interleukin-1(IL-1), Interleukin-6 (IL-6), mixed lineage kinase domain-like (MLKL), receptor interacting protein kinase 3 (RIPK3) and chemokine C-C ligand 2 (CCL-2)'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['nicotinamide', 'Nicotinamide supplementation', 'motor rehabilitation', 'rehabilitation', 'exercise', 'falls', 'older adults', 'accidental falls', 'frail older adults', 'dietary supplementation'], 'conditions': ['Frailty', 'Fall', 'Frailty Syndrome', 'Falls']}, 'referencesModule': {'references': [{'pmid': '23523272', 'type': 'BACKGROUND', 'citation': 'Ambrose AF, Paul G, Hausdorff JM. Risk factors for falls among older adults: a review of the literature. Maturitas. 2013 May;75(1):51-61. doi: 10.1016/j.maturitas.2013.02.009. Epub 2013 Mar 22.'}, {'pmid': '34659833', 'type': 'BACKGROUND', 'citation': 'Tsao YL, Hsu CC, Chen KT. Blunt Traumatic Retropharyngeal Hematoma with Respiratory Symptoms: A Systematic Review of Reported Cases. Emerg Med Int. 2021 Oct 7;2021:5158403. doi: 10.1155/2021/5158403. eCollection 2021.'}, {'pmid': '8481831', 'type': 'BACKGROUND', 'citation': 'Hayes WC, Myers ER, Morris JN, Gerhart TN, Yett HS, Lipsitz LA. Impact near the hip dominates fracture risk in elderly nursing home residents who fall. Calcif Tissue Int. 1993 Mar;52(3):192-8. doi: 10.1007/BF00298717.'}, {'pmid': '29512120', 'type': 'BACKGROUND', 'citation': 'Florence CS, Bergen G, Atherly A, Burns E, Stevens J, Drake C. Medical Costs of Fatal and Nonfatal Falls in Older Adults. J Am Geriatr Soc. 2018 Apr;66(4):693-698. doi: 10.1111/jgs.15304. Epub 2018 Mar 7.'}, {'pmid': '34682586', 'type': 'BACKGROUND', 'citation': 'Loureiro V, Gomes M, Loureiro N, Aibar-Almazan A, Hita-Contreras F. Multifactorial Programs for Healthy Older Adults to Reduce Falls and Improve Physical Performance: Systematic Review. Int J Environ Res Public Health. 2021 Oct 15;18(20):10842. doi: 10.3390/ijerph182010842.'}, {'pmid': '31171417', 'type': 'BACKGROUND', 'citation': 'Cruz-Jentoft AJ, Sayer AA. Sarcopenia. Lancet. 2019 Jun 29;393(10191):2636-2646. doi: 10.1016/S0140-6736(19)31138-9. Epub 2019 Jun 3.'}, {'pmid': '35055695', 'type': 'BACKGROUND', 'citation': 'Rodrigues F, Domingos C, Monteiro D, Morouco P. A Review on Aging, Sarcopenia, Falls, and Resistance Training in Community-Dwelling Older Adults. Int J Environ Res Public Health. 2022 Jan 13;19(2):874. doi: 10.3390/ijerph19020874.'}, {'pmid': '34886293', 'type': 'BACKGROUND', 'citation': 'Sun M, Min L, Xu N, Huang L, Li X. The Effect of Exercise Intervention on Reducing the Fall Risk in Older Adults: A Meta-Analysis of Randomized Controlled Trials. Int J Environ Res Public Health. 2021 Nov 29;18(23):12562. doi: 10.3390/ijerph182312562.'}, {'pmid': '30703272', 'type': 'BACKGROUND', 'citation': 'Sherrington C, Fairhall NJ, Wallbank GK, Tiedemann A, Michaleff ZA, Howard K, Clemson L, Hopewell S, Lamb SE. Exercise for preventing falls in older people living in the community. Cochrane Database Syst Rev. 2019 Jan 31;1(1):CD012424. doi: 10.1002/14651858.CD012424.pub2.'}, {'pmid': '34819097', 'type': 'BACKGROUND', 'citation': 'Chen Y, Zhang Y, Guo Z, Bao D, Zhou J. Comparison between the effects of exergame intervention and traditional physical training on improving balance and fall prevention in healthy older adults: a systematic review and meta-analysis. J Neuroeng Rehabil. 2021 Nov 24;18(1):164. doi: 10.1186/s12984-021-00917-0.'}, {'pmid': '36630860', 'type': 'BACKGROUND', 'citation': 'Adjetey C, Karnon B, Falck RS, Balasubramaniam H, Buschert K, Davis JC. Cost-effectiveness of exercise versus multimodal interventions that include exercise to prevent falls among community-dwelling older adults: A systematic review and meta-analysis. Maturitas. 2023 Mar;169:16-31. doi: 10.1016/j.maturitas.2022.12.003. Epub 2023 Jan 9.'}, {'pmid': '32234291', 'type': 'BACKGROUND', 'citation': 'Angulo J, El Assar M, Alvarez-Bustos A, Rodriguez-Manas L. Physical activity and exercise: Strategies to manage frailty. Redox Biol. 2020 Aug;35:101513. doi: 10.1016/j.redox.2020.101513. Epub 2020 Mar 20.'}, {'pmid': '28153946', 'type': 'BACKGROUND', 'citation': 'Alvarez C, Ramirez-Campillo R, Ramirez-Velez R, Izquierdo M. Effects and prevalence of nonresponders after 12 weeks of high-intensity interval or resistance training in women with insulin resistance: a randomized trial. J Appl Physiol (1985). 2017 Apr 1;122(4):985-996. doi: 10.1152/japplphysiol.01037.2016. Epub 2017 Feb 2.'}, {'pmid': '36599349', 'type': 'BACKGROUND', 'citation': 'Lopez-Otin C, Blasco MA, Partridge L, Serrano M, Kroemer G. Hallmarks of aging: An expanding universe. Cell. 2023 Jan 19;186(2):243-278. doi: 10.1016/j.cell.2022.11.001. Epub 2023 Jan 3.'}, {'pmid': '33353981', 'type': 'BACKGROUND', 'citation': 'Covarrubias AJ, Perrone R, Grozio A, Verdin E. NAD+ metabolism and its roles in cellular processes during ageing. Nat Rev Mol Cell Biol. 2021 Feb;22(2):119-141. doi: 10.1038/s41580-020-00313-x. Epub 2020 Dec 22.'}, {'pmid': '35203360', 'type': 'BACKGROUND', 'citation': 'Ji LL, Yeo D. Maintenance of NAD+ Homeostasis in Skeletal Muscle during Aging and Exercise. Cells. 2022 Feb 17;11(4):710. doi: 10.3390/cells11040710.'}, {'pmid': '32365524', 'type': 'BACKGROUND', 'citation': 'Hwang ES, Song SB. Possible Adverse Effects of High-Dose Nicotinamide: Mechanisms and Safety Assessment. Biomolecules. 2020 Apr 29;10(5):687. doi: 10.3390/biom10050687.'}, {'pmid': '11126400', 'type': 'BACKGROUND', 'citation': 'Knip M, Douek IF, Moore WP, Gillmor HA, McLean AE, Bingley PJ, Gale EA; European Nicotinamide Diabetes Intervention Trial Group. Safety of high-dose nicotinamide: a review. Diabetologia. 2000 Nov;43(11):1337-45. doi: 10.1007/s001250051536.'}, {'pmid': '26001219', 'type': 'BACKGROUND', 'citation': 'Preyat N, Rossi M, Kers J, Chen L, Bertin J, Gough PJ, Le Moine A, Rongvaux A, Van Gool F, Leo O. Intracellular nicotinamide adenine dinucleotide promotes TNF-induced necroptosis in a sirtuin-dependent manner. Cell Death Differ. 2016 Jan;23(1):29-40. doi: 10.1038/cdd.2015.60. Epub 2015 May 22.'}]}, 'descriptionModule': {'briefSummary': 'Falls are unplanned events resulting in contact with a lower surface. They are common in older adults, affecting one in three individuals over 65 years old. They have serious consequences, ranging from physical injuries (fractures, traumatic brain injury) to psychological repercussions. Physical training focused on muscle strength, balance, and gait has consistently been shown to prevent falls. However, there are significant challenges in its implementation, such as the need for trained personnel and long intervention times, which are associated with high costs. Therefore, developing strategies to improve the efficiency of physical training programs in older adults is mandatory. The reduced response to physical training in older adults compared to younger individuals is a well-documented phenomenon, reflecting physiological changes associated with aging.\n\nNicotinamide adenine dinucleotide (NAD+) is an essential coenzyme for cells, mediating energy metabolism and participating in crucial processes such as DNA repair, mitochondrial function, and cell death. As we age, NAD+ levels decrease in various tissues (including the brain and muscle), contributing to the development of aging phenotypes and associated pathologies. Preclinical evidence suggests that increasing NAD+ levels reduces the appearance of aging phenotypes. During physical activity, cellular metabolic pathways that increase the demand for NAD+ to support energy production in mitochondria are activated. This increase in demand is associated with the upregulation of key enzymes involved in NAD+ degradation promoted by exercise. Considering the decrease in cellular levels of this coenzyme associated with aging, it can be hypothesized that NAD+ deficiency may play a significant role in the reduced response of older adults to training programs. Nicotinamide, a water-soluble form of vitamin B3 currently considered a nutritional supplement, is a fundamental precursor for NAD+ synthesis, capable of raising cellular levels of it. It has already been used in clinical practice in the treatment of certain endocrinological and dermatological conditions. This study aims to determine through a randomized clinical trial whether nicotinamide supplementation improves physical performance in older adults at risk of falls undergoing a physical training program.', 'detailedDescription': 'To test the hypothesis, a randomized pilot clinical trial will be conducted using block allocation, double-blind (patient and evaluator), designed according to the SPIRIT guidelines for drafting a trial protocol. This study involves the implementation of guided home-based physical training by a physiotherapist (2 sessions per week for 4 weeks) combined with supplementation with nicotinamide (1.5 g/day) or placebo depending on the assigned group. Improvement in physical performance will be evaluated using the Short Physical Performance Battery (SPPB), handgrip strength test, quadriceps dynamometry, posturography, and near-infrared spectroscopy (NIRS) of the quadriceps. The RedCap software will be used for randomization and data analysis.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['OLDER_ADULT'], 'minimumAge': '65 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Aged 65 years or older\n* Living in the community\n* Increased risk of falls, defined as:\n* More than two falls in the last 12 months or\n* Altered balance test (unable to maintain unipedal stance \\> 5 seconds) or\n* SPPB score less than 10 points\n\nExclusion Criteria:\n\n* Known Muscle Disease (dystrophy, myopathy, or similar)\n* Motor sequelae of stroke\n* Joint pathology with severe pain preventing strength exercises\n* Cognitive impairment that renders the informed consent process impossible.'}, 'identificationModule': {'nctId': 'NCT06465602', 'acronym': 'NICE-FIT', 'briefTitle': 'Nicotinamide Supplementation Improves Physical Performance in Older Adults at Risk of Falls', 'organization': {'class': 'OTHER', 'fullName': 'University of Chile'}, 'officialTitle': 'Nicotinamide Supplementation Improves Physical Performance in Older Adults at Risk of Falls: a Pilot Randomized Clinical Trial', 'orgStudyIdInfo': {'id': 'FONDAP 15150012 GERO'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Nicotinamide supplementation group', 'description': 'At the beginning and end of the study, blood samples will be taken for the measurement of IL-6, CCL2, TNF-alpha, and NFL, and participants will be assessed using the Short Physical Performance Battery (SPPB), quadriceps dynamometry (LY-D Lynx Dynamo), quadriceps oxygen saturation (with NIRS), and posturography to determine the center of pressure (COP) area with the HUR BTG4 posturography system, and SmartBalance® software. Subjects will receive 1.5 grams per day of nicotinamide, orally, for 30 days. During this period, they will undergo a home-based physical training program guided by a physiotherapist. The sessions will be 50 minutes long (10 minutes warm-up, 30 minutes strength and balance training, and 10 minutes flexibility), twice a week.', 'interventionNames': ['Drug: Nicotinamide']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo group', 'description': 'Same physical evaluation and blood sampling as the experimental group. The subjects will receive 1.5 grams per day of placebo (talc, the medium in which nicotinamide is prepared), orally, for 30 days. The bottle and the capsules will be of the same physical characteristics (shape, color, and flavor) in both groups. During that period, patients will assess patient adherence and possible adverse effects.', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'Nicotinamide', 'type': 'DRUG', 'otherNames': ['Niacinamide'], 'description': 'The subjects will receive 1.5 grams per day of Nicotinamide, orally, for 30 days.', 'armGroupLabels': ['Nicotinamide supplementation group']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'The subjects will receive 1.5 grams per day of placebo, orally, for 30 days.', 'armGroupLabels': ['Placebo group']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Santiago', 'status': 'RECRUITING', 'country': 'Chile', 'contacts': [{'name': 'Felipe Salech, MD PhD', 'role': 'CONTACT'}], 'facility': 'Hospital Clínico Universidad de Chile', 'geoPoint': {'lat': -33.45694, 'lon': -70.64827}}], 'centralContacts': [{'name': 'Felipe H Salech Morales, MD PhD', 'role': 'CONTACT', 'email': 'fhsalech@uchile.cl', 'phone': '229788546', 'phoneExt': '+56'}, {'name': 'María Isabel Behrens, MD', 'role': 'CONTACT', 'email': 'miobehrens@hcuch.cl', 'phone': '229789404'}], 'overallOfficials': [{'name': 'Felipe H Salech Morales, MD-PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Chile'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Chile', 'class': 'OTHER'}, 'collaborators': [{'name': 'Centro FONDAP de Gerociencia, Salud mental y Metabolismo (GERO)', 'class': 'UNKNOWN'}, {'name': 'Center for Advanced Clinical Research (CICA ) - University of Chile', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'SPONSOR'}}}}