Clinical trial NCT06794255: Exploratory Study on the Role of Vitamin C in Promoting Health in Middle-Aged and Elderly Adults
Official title: Randomized Controlled Trial on Vitamin C Supolementation for HealthRegulation in Middle-Aged and Elderly Adults
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Ageing
Lead sponsor: Peking University Third Hospital
Sponsor class: OTHER
First posted: 2025-01-27
Enrollment: 400
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


Eligibility criteria: 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).

Primary outcomes:
measure: Evaluate the effectiveness of vitamin C in intervening in aging
timeFrame: 12 months
Secondary outcomes:
measure: blood cell transcriptomics
timeFrame: 12 months
measure: proteomics
timeFrame: 12 months
measure: metabolomics
timeFrame: 12 months
measure: gut microbiome
timeFrame: 12 months
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking University Third Hospital
Study officials:
References: