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Effect of Vitamin B9, B12, and D on Clinical Markers and Biomarkers in Dwelling Older Adults

Effect of vitaminB9, B12, and D on clinical markers and biomarkers in dwelling older adults

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
TCTR
Registry ID
TCTR20250317011
Enrollment
152
Registered
2025-03-17
Start date
2024-06-26
Completion date
Unknown
Last updated
2026-08-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pre-frail elderly participants who do not supplement with vitamins B and D. Aging-related diseases Elderly population Frailty syndrome Nutrition Epigenetics Epigenetic biomarkers DNA methylation Vitamin B9 Vitamin B12 Vitamin D Depression Dementia Immunosenescence

Interventions

Participants in the control group were administered a placebo designed to mimic the appearance and characteristics of the active vitamin supplements.,Participants in Group B were administered vitamin
Placebo Comparator No treatment,Active Comparator Dietary Supplement,Active Comparator Dietary Supplement,Active Comparator Dietary Supplement

Sponsors

National Research Council of Thailand (NRCT)
Lead Sponsor

Eligibility

Sex/Gender
All
Age
60 Years to 99 Years

Inclusion criteria

Inclusion criteria: 1. Thai elderly participances age 60 years or older, 2. Participances must meet the pre-frail criteria as assessed by the Fried frailty phenotypes.

Exclusion criteria

Exclusion criteria: 1. Individuals with communication difficulties, 2. Persons who score below 18 on the Thai Mental State Examination, 3. Persons in the terminal stage of life with a life expectancy of less than 6 months, 4. Elderly individuals with uncontrolled chronic diseases, such as those with respiratory or circulatory failure, 5. Individuals with chronic kidney disease, 6. Persons with physical impairments, such as amputations or deformities of the legs and feet, including paralysis and weakness, 7. Persons who have received blood transfusions, had acute infections, or vaccinations within the last month, 8. Persons with chronic infections and those on immunosuppressive or immunostimulatory drugs, 9. Persons who have taken or are currently taking any of the following: B complex, B9, B12, or D vitamins within the 4 months prior to study enrollment, 10. Persons with vitamin D levels less than 30 nmol/L.

Design outcomes

Primary

MeasureTime frame
Physical characteristics at 6 and 12 months after the intervention chair stand, functional reach, gait speed in 4 meters, hand grip strength, and sit and reach,Blood parameters at 6 and 12 months after the intervention chemiluminescence, electrical resistance, hydrodynamic focusing, SLS-haemoglobin, and high-performance liquid chromatography methods and Chronic Kidney Disease Epidemiology Collaboration equation,Neurodegenerative disease at 6 and 12 months after the intervention Thai Mental State Examination (TMSE), Montreal Cognitive Assessment-Thai version (MOCA-Thai),Genetics and epigenetics at 6 and 12 months after the intervention sanger sequencing, Infinium MethylationEPIC array, bioinformatic analysis,Depressive disorder at 6 and 12 months after the intervention Thai Geriatric Depression Scale (TGDS)

Secondary

MeasureTime frame
Vitamins knowledge and understanding Cross-sectional at the recruiment questionnaire,Food screener for DNA methylation level at 6 and 12 moths after the intervention diet quality questionnaire, food record

Countries

Thailand

Contacts

Public ContactChanachai Sae Lee

Faculty of Medicine Siriraj Hospital, Mahidol University

chanachai.sae@mahidol.ac.th024192806

Outcome results

None listed

Source: TCTR (via WHO ICTRP) · Data processed: Aug 10, 2026