Exploratory Study on the Role of Vitamin C in Promoting Health in Middle-Aged and Elderly Adults

NCT06794255 | Recruiting DMC

• 2 other identifiers: M202465188888888
• Study Type: interventional
• Target: 400
• Locations: 1 country
• Sites: 3

Brief Summary

The purpose of this clinical trial is to understand whether oral vitamin C can help delay the aging of middle-aged and elderly individuals, search for sensitive biomarkers of human aging, and provide new paradigms and scientific guidance for aging intervention with small molecule drugs. The main questions it aims to answer are as follows:

• Can oral vitamin C effectively improve the aging-related indicators?
• What is the safety of participants when taking vitamin C supplements? Researchers will compare vitamin C with a placebo to observe whether vitamin C is effective in intervening in the aging of middle-aged and elderly individuals. Participants need to:
• Take 2 tablets (250mg/tablet) of vitamin C or placebo after breakfast and dinner every day for 12 consecutive months;
• Go to the designated place for a face-to-face follow-up every 6 months and receive a telephone follow-up every 2 months, and pick up subsequent drugs during the follow-up;
• Honestly inform the medication situation during each follow-up;
• Report any discomfort or adverse reactions that occur during the treatment process to the researchers;
• Fill in a questionnaire about their own health status during each follow-up;
• After 6 months and 12 months of intervention, conduct a comprehensive health examination as required, including blood tests and other items.

Conditions

Ageing

Outcome Measures

Primary Outcomes (1)

• Evaluate the effectiveness of vitamin C in intervening in aging

  DNA methylation composite clock

  12 months

Secondary Outcomes (11)

• blood cell transcriptomics

  12 months

• proteomics

  12 months

• metabolomics

  12 months

• gut microbiome

  12 months

• Cognitive function

  1 year

Study Arms (3)

Vitamin C

EXPERIMENTAL

Participants will take the synthetic vitamin C twice a day, 500mg per time

Dietary Supplement: Vitamin C

Placebo

PLACEBO COMPARATOR

Participants will take tablets with the same texture, flavor, and appearance as the experimental group twice a day, 500mg per time.

Other: Placebo

Baseline control

NO INTERVENTION

Recruit 100 healthy individual volunteers aged 18 - 70 years old (20 volunteers in the age range of 18 - 30, 20 in 30 - 40, 20 in 40 - 50, 20 in 50 - 60, and 20 in 60 - 70, with an equal number of males and females in each age group) as the baseline control for age-related changes. This group will not receive any intervention.

Interventions

Vitamin C DIETARY_SUPPLEMENT

Participants swallow synthetic vitamin C tablets 500mg with water, twice a day.

Vitamin C

Placebo OTHER

Participants swallow tablets with the same texture, flavor, and appearance as the experimental group 500mg with water, twice a day.

Placebo

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age: 55-65 years (for the experimental and control groups) or 18-70 years (for the baseline control group assessing aging changes).
• Health Status: Deemed to be in good health based on medical evaluation, including medical history, physical examination, laboratory tests, and cardiac monitoring.
• Weight: BMI within the range of 18.5-28 kg/m².
• Informed Consent: Capable of signing the informed consent form and complying with the requirements and restrictions outlined in the study protocol.

You may not qualify if:

• Disease Status:Uncontrolled medical conditions or any disease that, in the investigator's opinion, may pose an inappropriate risk or contraindication or interfere with the study's objectives, conduct, or evaluation.Severe chronic or acute diseases (e.g., cancer, heart failure, renal insufficiency, COPD, diabetes, active liver disease, metabolic acidosis, poorly controlled hypertension, epilepsy, recent cardiovascular events, inflammatory bowel disease, neurological disorders, infectious diseases, severe autoimmune diseases, etc.).
• Weight: BMI \< 18.5 or BMI \> 28.
• Substance/Alcohol Abuse: Ongoing alcohol or drug abuse, or excessive alcohol consumption.
• Medical History: History of gastrointestinal diseases, hyperuricemia, kidney or urinary tract stones, glucose-6-phosphate dehydrogenase deficiency, or paroxysmal nocturnal hemoglobinuria.
• Allergy: Allergy to vitamin C or any component of its formulation.
• Recent Medication Use: Use of high-dose vitamin C, vitamin E, low-dose aspirin, acarbose, metformin, NMN/NR, or other anti-aging/weight-loss drugs within the past 3 months.
• Informed Consent: Inability to provide informed consent.
• Other: Any physical condition that, in the investigator's opinion, may adversely affect the study process or outcomes.
• Clinical Research Participation: Participation in any other clinical research within 3 months prior to screening or during the study period, or receipt of chemotherapy, radiotherapy, biologic therapy, small-molecule therapeutic agents, or investigational drugs, with incomplete recovery from related side effects (excluding alopecia or potential neuropathy).

Sponsors & Collaborators

• Peking University Third Hospital: lead
• The First Affiliated Hospital of Nanchang University: collaborator
• People's Hospital of Quzhou: collaborator

Study Sites (3)

The first affiliated hospital of Nanchang University

Nanchang, Jiangxi, 330006, China

RECRUITING

People's Hospital of Quzhou

Quzhou, Zhejiang, 324000, China

RECRUITING

Peking University Third Hospital

Beijing, 100191, China

ENROLLING BY INVITATION

MeSH Terms

Interventions

Ascorbic Acid

Intervention Hierarchy (Ancestors)

Sugar Acids; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Hydroxy Acids; Carbohydrates

Central Study Contacts

Tian Tian

CONTACT

+8601082266355; tiantianpku@126.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: January 10, 2025
• First Posted: January 27, 2025
• Study Start: April 2, 2025
• Primary Completion: January 30, 2026
• Study Completion (Estimated): January 30, 2027
• Last Updated: June 27, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

CN (3)