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

Randomized Controlled Trial on Vitamin C Supolementation for HealthRegulation in Middle-Aged and Elderly Adults

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.

Study Overview

• Status: Recruiting
• Conditions: Ageing
• Intervention / Treatment: Dietary supplement: Vitamin C; Other: Placebo

• Study Type: Interventional
• Enrollment (Estimated): 400
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Tian Tian; Phone Number: +8601082266355; Email: tiantianpku@126.com

Study Locations

• China
  • Beijing, China, 100191
    • Enrolling by invitation
    • Peking University Third Hospital
  • Jiangxi
    • Nanchang, Jiangxi, China, 330006
      • Recruiting
      • The First Affiliated Hospital of Nanchang University
      • Contact: Wei Zhang; Phone Number: 15797738055; Email: zhangweiliuxin@163.com
  • Zhejiang
    • Quzhou, Zhejiang, China, 324000
      • Recruiting
      • People's Hospital of Quzhou
      • Contact: Feng Zhang; Email: felix.f.zhang@outlook.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Vitamin C; Participants will take the synthetic vitamin C twice a day, 500mg per time	Dietary supplement: Vitamin C; Participants swallow synthetic vitamin C tablets 500mg with water, twice a day.
Placebo Comparator: Placebo; Participants will take tablets with the same texture, flavor, and appearance as the experimental group twice a day, 500mg per time.	Other: Placebo; Participants swallow tablets with the same texture, flavor, and appearance as the experimental group 500mg with water, twice a day.
No Intervention: Baseline control; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Evaluate the effectiveness of vitamin C in intervening in aging	DNA methylation composite clock	12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
blood cell transcriptomics	blood cell transcriptomics	12 months
proteomics	proteomics in blood	12 months
metabolomics	metabolomics in blood	12 months
gut microbiome	gut microbiome in fecal sample	12 months
Cognitive function	Trail Making Test	1 year
Physical Fitness Test	The score of Purdue pegboard test, Grip Strength Test，and Single Leg Stand Test with Eyes Closed	1 year
Maximal oxygen consumption	Maximal oxygen consumption	1 year
Motor Function	Hamilton Anxiety Scale	1 year
muscle mass	By means of measurement of lean body mass using dual-energy X-ray absorptiometry (DXA)	1 year
Cardiovascular disease	Standardised composite score (Z score) of systolic blood pressure, LDL cholesterol, and body-mass index (BMI).	1 year
Vitamin C level	Vitamin C level in serum	1 year

Collaborators and Investigators

• Sponsor: Peking University Third Hospital
• Collaborators: The First Affiliated Hospital of Nanchang University; People's Hospital of Quzhou

Study record dates

Study Major Dates

• Study Start (Actual): April 2, 2025
• Primary Completion (Estimated): January 30, 2026
• Study Completion (Estimated): January 30, 2027

Study Registration Dates

• First Submitted: January 10, 2025
• First Submitted That Met QC Criteria: January 20, 2025
• First Posted (Actual): January 27, 2025

Study Record Updates

• Last Update Posted (Actual): June 27, 2025
• Last Update Submitted That Met QC Criteria: June 23, 2025
• Last Verified: January 1, 2025

More Information

Terms related to this study

• Other Study ID Numbers: M2024651; 88888888 (Other Grant/Funding Number: Peking University Third Hospital)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: I have decided not to share the IPD from this study due to concerns about participant privacy and confidentiality. Our study will include multiple-omic data, including genomic data. There are legal and ethical considerations that restrict the sharing of sensitive health information and genetic information without consent. Furthermore, the resources required to prepare and manage the data for external sharing are currently beyond our capacity. Therefore, to ensure the protection of our participants and comply with ethical standards, we have opted not to share the IPD at this time.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No