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

ConditionAgeing
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-70
SponsorPeking University Third Hospital

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Vitamin C

    Dietary supplement

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

  • Placebo

    Other intervention

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

Treatment groups

400 Participants
are divided into 3 treatment groups
Group A: Vitamin CExperimental treatment 1 intervention
Group B: PlaceboPlacebo comparator 1 intervention
Group C: Baseline controlNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

Evaluate the effectiveness of vitamin C in intervening in aging

DNA methylation composite clock

Time frame
12 months

Secondary outcomes

1

blood cell transcriptomics

blood cell transcriptomics

Time frame
12 months
2

proteomics

proteomics in blood

Time frame
12 months
3

metabolomics

metabolomics in blood

Time frame
12 months
4

gut microbiome

gut microbiome in fecal sample

Time frame
12 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Peking University Third Hospital

Lead sponsor

The First Affiliated Hospital of Nanchang University

Collaborator

People's Hospital of Quzhou

Collaborator