Exploratory Study on the Role of Vitamin C in Promoting Health in Middle-Aged and Elderly Adults
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Vitamin C, Placebo.
- Who it may be relevant to
- Registry conditions: Ageing. Basic parameters: 18 years — 70 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Randomized Controlled Trial on Vitamin C Supolementation for HealthRegulation in Middle-Aged and Elderly Adults
Overview
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.
Interventions
- Dietary supplement Vitamin C
Participants swallow synthetic vitamin C tablets 500mg with water, twice a day. - Other Placebo
Participants swallow tablets with the same texture, flavor, and appearance as the experimental group 500mg with water, twice a day.
Primary outcome measures
- Evaluate the effectiveness of vitamin C in intervening in aging [Time frame: 12 months]
Secondary outcome measures (11)
- blood cell transcriptomics [Time frame: 12 months]
- proteomics [Time frame: 12 months]
- metabolomics [Time frame: 12 months]
- gut microbiome [Time frame: 12 months]
- Cognitive function [Time frame: 1 year]
- Physical Fitness Test [Time frame: 1 year]
- Maximal oxygen consumption [Time frame: 1 year]
- Motor Function [Time frame: 1 year]
- muscle mass [Time frame: 1 year]
- Cardiovascular disease [Time frame: 1 year]
- Vitamin C level [Time frame: 1 year]
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).
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Triple blind
- Primary purpose
- Prevention
Study locations
China · 3 centers
- The first affiliated hospital of Nanchang University — Nanchang
- People's Hospital of Quzhou — Quzhou
- Peking University Third Hospital — Beijing
Identifiers
NCT: NCT06794255 · M2024651 · 88888888