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NCT Number: NCT06794255

Exploratory Study on the Role of Vitamin C in Promoting Health 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.

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Key information

Conditions

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The first affiliated hospital of Nanchang University, Nanchang, Jiangxi, China

Loading trial locations.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

Vitamin C

Dietary Supplement

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

Placebo

Other

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

Primary outcomes

  1. Evaluate the effectiveness of vitamin C in intervening in aging

    Time frame: 12 months

    DNA methylation composite clock

Secondary outcomes

  1. blood cell transcriptomics

    Time frame: 12 months

    blood cell transcriptomics

  2. proteomics

    Time frame: 12 months

    proteomics in blood

  3. metabolomics

    Time frame: 12 months

    metabolomics in blood

  4. gut microbiome

    Time frame: 12 months

    gut microbiome in fecal sample

  5. Cognitive function

    Time frame: 1 year

    Trail Making Test

  6. Physical Fitness Test

    Time frame: 1 year

    The score of Purdue pegboard test, Grip Strength Test,and Single Leg Stand Test with Eyes Closed

  7. Maximal oxygen consumption

    Time frame: 1 year

    Maximal oxygen consumption

  8. Motor Function

    Time frame: 1 year

    Hamilton Anxiety Scale

  9. muscle mass

    Time frame: 1 year

    By means of measurement of lean body mass using dual-energy X-ray absorptiometry (DXA)

  10. Cardiovascular disease

    Time frame: 1 year

    Standardised composite score (Z score) of systolic blood pressure, LDL cholesterol, and body-mass index (BMI).

  11. Vitamin C level

    Time frame: 1 year

    Vitamin C level in serum

Study contacts

Contact information is provided by the study sponsor or research team.

Sponsors and collaborators

Lead sponsor

Peking University Third Hospital

Other

Collaborators

  • People's Hospital of Quzhou
  • The First Affiliated Hospital of Nanchang University

Registry information

Official study title

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

Acronym: VitC-Aging

Important dates

Study start
2025
Primary completion
2026
Study completion
2027
First posted
Jan 27, 2025
Registry last updated
Jun 27, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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