Therapeutic Effect of Vitamin C Supplementation in Patients With Ovarian Aging

NCT ID: NCT06794060

Last Updated: 2025-06-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

354 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-07-02

Study Completion Date

2027-08-31

Brief Summary

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The goal of this clinical trial is to learn if Vitamin C works to improve ovarian reserve in women with ovarian aging. It will also learn about the safety of Vitamin C. The main questions it aims to answer are:

* Does Vitamin C supplementation improve the ovarian reserve prediction score?
* What medical problems do participants have when taking Vitamin C supplementation?

Researchers will compare Vitamin C to a placebo (a look-alike substance that contains no drug) to see if drug Vitamin C works to improve ovarian reserve in women with ovarian aging. Participants will:

* Take Vitamin C or a placebo every day for 12 months
* Visit the clinic once every 4 weeks for follow-up and drug distribution.
* Return the Vitamin C box at each visit.
* Report any adverse effects of treatment to the doctor.
* Fill out a questionnaire at each visit.
* After 6 months and 12 months of intervention, take blood test and ultrasonic examination.

Detailed Description

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Conditions

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Premature Ovarian Insufficiency Ovarian Reserve Function

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Outcome Assessors
A double-blind design was employed for researchers were designed to be blinded. Allocation concealment was designed to apply to study subjects, clinical practitioners, outcome assessors and subsequent data analysts. The pharmaceutical company assigned numbers and labels to the drugs, and when study subjects were enrolled, they were assigned the corresponding drug number. The specific group corresponding to the number remained concealed from the project researchers, participants, and study subjects, with the blind data kept by independent personnel.

After the follow-up, independent personnel who maintained the blind data provided group information to the data analysts. The synthetic vitamin C, natural vitamin C and control groups were still represented as A, B and C, concealing the specific identities of the ABC groups from the data analysts. After the data comparison between the two groups the unblinding of the AB groups was conducted.

Study Groups

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Synthetic vitamin C

Participants will take the synthetic vitamin C twice a day, 500mg per time.

Group Type EXPERIMENTAL

Vitamin C (Ascorbic Acid)

Intervention Type DIETARY_SUPPLEMENT

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

Natural vitamin C

Participants will take the natural vitamin C twice a day, 500mg per time.

Group Type EXPERIMENTAL

Vitamin C (Ascorbic Acid)

Intervention Type DIETARY_SUPPLEMENT

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

Placebo

Participants will take tablets with the same texture, flavor, and appearance as the experimental group twice a day, 500mg per time.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type OTHER

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

Interventions

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Vitamin C (Ascorbic Acid)

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

Intervention Type DIETARY_SUPPLEMENT

Vitamin C (Ascorbic Acid)

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

Intervention Type DIETARY_SUPPLEMENT

Placebo

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

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Regularity of menstruation changed for less than one year.
* 10U/L≤ FSH\<25 U/L in two tests more than 4weeks aprt.
* AMH \< 1.1 ng/mL.
* Bilateral ovarian AFC \<7.
* Signed informed consent and can participate in regular follow-ups.

Exclusion Criteria

* Ovarian aging caused by TUNER (X deletion) syndrome or gene mutation.
* Ovarian aging caused by ovarian surgery or chemotherapy.
* Patients with severe endocrine system diseases (diabetes, thyroid disease), digestive system diseases (affecting VC absorption), cardiovascular system diseases, renal insufficiency (abnormal urine, imaging diagnosis, blood, pathological analysis confirms that kidney damage does exist, or glomerular filtration rate GFR \<60mL/min), nervous system diseases such as dementia and epilepsy; patients with infectious diseases such as HIV, hepatitis, tuberculosis; patients with severe autoimmune diseases.
* Continuous alcohol or drug abuse (to avoid adverse reactions caused by drinking).
* Allergic to vitamin C or any component of the preparation.
* Patients who have already started large-dose (greater than 500mg/day) vitamin C supplementation.
* Unwilling to or stop taking supplements not provided by this project.
* Those who have participated in other ovarian aging clinical intervention projects.
Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Peking University Third Hospital

OTHER

Sponsor Role lead

Responsible Party

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Jie Qiao

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Central Contacts

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Tian Tian

Role: CONTACT

+8601082266355

Other Identifiers

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M2024647

Identifier Type: -

Identifier Source: org_study_id

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