Therapeutic Effect of Vitamin C Supplementation in Patients With Ovarian Aging

NCT06794060 | Not Yet Recruiting DMC

• 1 other identifier: M2024647
• Study Type: interventional
• Target: 354
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Premature Ovarian Insufficiency; Ovarian Reserve Function

Outcome Measures

Primary Outcomes (1)

• ovarian reserve prediction score

  The ovarian reserve prediction score was calculated using the Ovarian Reserve Prediction Tool, OvaRePred. This tool evaluates the current ovarian reserve status and predicts the future age at which diminished ovarian reserve (DOR) and perimenopause may occur. The score ranges from 0 to 100, with higher scores indicating better ovarian function.

  1 year

Secondary Outcomes (6)

• FSH level

  1 year

• AMH level

  12 months

• AFC

  12 months

• Clinical pregnancy rate

  12 months

• Time to pregnancy

  12 months

Study Arms (3)

Synthetic vitamin C

EXPERIMENTAL

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

Dietary Supplement: Vitamin C (Ascorbic Acid)

Natural vitamin C

EXPERIMENTAL

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

Dietary Supplement: Vitamin C (Ascorbic Acid)

Placebo

PLACEBO COMPARATOR

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

Other: Placebo

Interventions

Vitamin C (Ascorbic Acid) DIETARY_SUPPLEMENT

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

Synthetic vitamin C

Placebo OTHER

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

Placebo

Eligibility Criteria

• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Regularity of menstruation changed for less than one year.
• U/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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Peking University Third Hospital: lead

MeSH Terms

Conditions

Primary Ovarian Insufficiency

Interventions

Ascorbic Acid

Condition Hierarchy (Ancestors)

Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Gonadal Disorders; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Sugar Acids; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Hydroxy Acids; Carbohydrates

Central Study Contacts

Tian Tian

CONTACT

+8601082266355; tiantianpku@126.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: January 10, 2025
• First Posted: January 27, 2025
• Study Start: July 2, 2025
• Primary Completion: December 31, 2025
• Study Completion (Estimated): August 31, 2027
• Last Updated: June 26, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share