PCOS (Polycystic Ovary Syndrome)NCT07723443
Effects of Folic Acid and Vitamin E on Hormones in Polycystic Ovary Syndrome
A study testing Vitamin E 400 and Folic Acid 5 Mg Oral Tablet in people with PCOS (Polycystic Ovary Syndrome), run by Al-Mustansiriyah University at 1 site in Iraq.
Trial summary
The goal of this prospective comparative interventional study is to evaluate serum Ezrin levels and investigate the effects of one-month supplementation with vitamin E and folic acid in Iraqi women of reproductive age diagnosed with polycystic ovary syndrome (PCOS) evaluating for infertility, as well as healthy… Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- PCOS (Polycystic Ovary Syndrome)
- What is being tested?
- Vitamin E 400 and Folic Acid 5 Mg Oral Tablet
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 207 participants
- Where
- 1 siteIraq
- Study dates
- 1 Jul 2025to 10 Feb 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Women of reproductive age with confirmed PCOS who presented with primary or secondary infertility
Who cannot join
- Patients with other endocrine disorders that could affect hormonal status, pregnancy, or recent use of hormonal or antioxidant therapy before enrollment
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Folic Acid and Vitamin E on Serum Ezrin and Hormonal Profile in Women With Polycystic Ovary Syndrome
The goal of this prospective comparative interventional study is to evaluate serum Ezrin levels and investigate the effects of one-month supplementation with vitamin E and folic acid in Iraqi women of reproductive age diagnosed with polycystic ovary syndrome (PCOS) evaluating for infertility, as well as healthy controls. The main questions it aims to answer are:
- Do serum Ezrin levels differ between women with PCOS and healthy controls, and do these levels change following intervention?
- What impact does one-month supplementation with vitamin E, folic acid, or their combination have on hormonal profiles (such as LH, FSH, testosterone, and SHBG) and clinical symptoms?
Read more
If there is a comparison group: Researchers will compare three PCOS treatment arms (vitamin E 400 IU/day, folic acid 5 mg/day, and a combination of both) to each other and to a baseline healthy control group to see if the interventions partially improve androgen bioavailability, reproductive hormonal balance, clinical symptoms like hirsutism, and whether they modulate circulating serum Ezrin levels.
Participants will:
- Take their assigned daily oral intervention (vitamin E, folic acid, or a combination of the two) for a duration of one month.
- Provide venous blood samples before treatment begins and after the one-month period to measure serum Ezrin concentrations and reproductive hormones.
- Undergo clinical and anthropometric assessments to document variables including body mass index (BMI), waist-to-hip ratio (WHR), blood pressure, acne, hirsutism, and menstrual cycle regularity.
- Conditions
- PCOS (Polycystic Ovary Syndrome)
- Being tested
- Vitamin E 400, Folic Acid 5 Mg Oral Tablet
- Keywords
- Polycystic ovary syndrome, Ezrin, Vitamin E, Folic acid, Hormonal profile, Free androgen index
- Medical subject headings
- Polycystic Ovary Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vitamin E 400Dietary supplement
Soft gelatin capsule of Vitamin E each contains 400 IU
Folic Acid 5 Mg Oral TabletDietary supplement
Film coated tablet of 5 mg folic acid
| Study group | Role | What they receive |
|---|---|---|
| Vitamin E group | Active comparator | The patients will receive 400 IU of vitamin E once daily for one month Receives: Dietary Supplement: Vitamin E 400 |
| Folic acid group | Active comparator | The patients will receive 5 mg of folic acid once daily for one month Receives: Dietary Supplement: Folic Acid 5 Mg Oral Tablet |
| The combination group | Experimental | The patients will receive 5 mg of folic acid and 400 IU of vitamin E once daily for one month Receives: Dietary Supplement: Vitamin E 400; Dietary Supplement: Folic Acid 5 Mg Oral Tablet |
| Healthy control | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ezrin
Serum levels of Ezrin
Measured: At baseline after one month of treatment
Follicle-stimulating hormone
Serum levels of follicle-stimulating hormone
Measured: At baseline and after one month of treatment
Luteinizing hormone
Serum levels of luteinizing hormone
Measured: At baseline after one month of treatment
Prolactin
Serum levels of prolactin hormone
Measured: At baseline after one month of treatment
Estradiol
Serum levels of estradiol hormone
Measured: At baseline after one month of treatment
Thyroid-stimulating hormone
Serum levels of thyroid-stimulating hormone
Measured: At baseline after one month of treatment
Total testosterone
Serum levels of total testosterone
Measured: At baseline after one month of treatment
Sex hormone-binding globulin
Serum levels of sex hormone-binding globulin
Measured: At baseline after one month of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jul 2026
- Study start1 Jul 2025
- Primary completion10 Feb 2026
- Study completion10 Feb 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PCOS (Polycystic Ovary Syndrome)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 207 participants (actual)
Sponsor and investigators
- Lead sponsor
- Al-Mustansiriyah University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Huda Jaber Waheed, Al-Mustansiriyah University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07723443
- Sponsor's protocol ID
- 63
- Status last verified
- Jul 2026
- First submitted
- 19 Jul 2026
- Last updated
- 23 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 23 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Folic Acid and Vitamin E on Serum Ezrin and Hormonal Profile in Women With Polycystic Ovary Syndrome
- ClinicalTrials.gov ID
- NCT07723443
- Acronym / sponsor ID
- 63
- Conditions
- PCOS (Polycystic Ovary Syndrome)
- Keywords
- Polycystic ovary syndrome, Ezrin, Vitamin E, Folic acid, Hormonal profile, Free androgen index
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 207 participants (actual)
- Lead sponsor
- Al-Mustansiriyah UniversityUniversity, hospital or other
- Study start
- 1 Jul 2025 (actual)
- Primary completion
- 10 Feb 2026 (actual)
- Study completion
- 10 Feb 2026 (actual)
- First posted
- 23 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this prospective comparative interventional study is to evaluate serum Ezrin levels and investigate the effects of one-month supplementation with vitamin E and folic acid in Iraqi women of reproductive age diagnosed with polycystic ovary syndrome (PCOS) evaluating for infertility, as well as healthy controls. The main questions it aims to answer are:
- Do serum Ezrin levels differ between women with PCOS and healthy controls, and do these levels change following intervention?
- What impact does one-month supplementation with vitamin E, folic acid, or their combination have on hormonal profiles (such as LH, FSH, testosterone, and SHBG) and clinical symptoms?
If there is a comparison group: Researchers will compare three PCOS treatment arms (vitamin E 400 IU/day, folic acid 5 mg/day, and a combination of both) to each other and to a baseline healthy control group to see if the interventions partially improve androgen bioavailability, reproductive hormonal balance, clinical symptoms like hirsutism, and whether they modulate circulating serum Ezrin levels.
Participants will:
- Take their assigned daily oral intervention (vitamin E, folic acid, or a combination of the two) for a duration of one month.
- Provide venous blood samples before treatment begins and after the one-month period to measure serum Ezrin concentrations and reproductive hormones.
- Undergo clinical and anthropometric assessments to document variables including body mass index (BMI), waist-to-hip ratio (WHR), blood pressure, acne, hirsutism, and menstrual cycle regularity.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Vitamin E group | Active comparator | Dietary Supplement: Vitamin E 400The patients will receive 400 IU of vitamin E once daily for one month |
| Folic acid group | Active comparator | Dietary Supplement: Folic Acid 5 Mg Oral TabletThe patients will receive 5 mg of folic acid once daily for one month |
| The combination group | Experimental | Dietary Supplement: Vitamin E 400, Dietary Supplement: Folic Acid 5 Mg Oral TabletThe patients will receive 5 mg of folic acid and 400 IU of vitamin E once daily for one month |
| Healthy control | No intervention | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Women of reproductive age with confirmed PCOS who presented with primary or secondary infertility
Key exclusion criteria (1 listed)
- Patients with other endocrine disorders that could affect hormonal status, pregnancy, or recent use of hormonal or antioxidant therapy before enrollment
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Vitamin E 400Soft gelatin capsule of Vitamin E each contains 400 IU | Dietary supplement | The combination group, Vitamin E group |
| Folic Acid 5 Mg Oral TabletFilm coated tablet of 5 mg folic acid | Dietary supplement | Folic acid group, The combination group |
Primary outcome
Ezrin
Time frame: At baseline after one month of treatment
Serum levels of Ezrin
Follicle-stimulating hormone
Time frame: At baseline and after one month of treatment
Serum levels of follicle-stimulating hormone
Luteinizing hormone
Time frame: At baseline after one month of treatment
Serum levels of luteinizing hormone
Prolactin
Time frame: At baseline after one month of treatment
Serum levels of prolactin hormone
Estradiol
Time frame: At baseline after one month of treatment
Serum levels of estradiol hormone
Thyroid-stimulating hormone
Time frame: At baseline after one month of treatment
Serum levels of thyroid-stimulating hormone
Total testosterone
Time frame: At baseline after one month of treatment
Serum levels of total testosterone
Sex hormone-binding globulin
Time frame: At baseline after one month of treatment
Serum levels of sex hormone-binding globulin
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jul 2026.
- Individual participant dataSharing planned: Undecided
Related trials for PCOS (Polycystic Ovary Syndrome)
Recruiting
Efficacy of Ovarian Drilling Via vNOTES Laparoscopy in Patients With PCOS
PCOS (Polycystic Ovary Syndrome)
RecruitingPhase 1
Efficacy of Injectable Vitamin D Supplementation in Females With Polycystic Ovary Syndrome
Anovulatory Infertility
RecruitingObservational study
The Value of LC-MS/MS Detection of Androgen Profiles in the Diagnosis of PCOS: A Prospective, Multicenter Real-world Study
Polycystic Ovary Syndrome (PCOS)
Recruiting
The Effects of the Mediterranean Diet and Synbiotics in Polycystic Ovary Syndrome
PCOS (Polycystic Ovary Syndrome)
Recruiting
Brown Adipose Tissue Modulation in Polycystic Ovary Syndrome Using Infrared Thermography
Polycystic Ovary Syndrome (PCOS)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Vitamin E 400 and Folic Acid 5 Mg Oral Tablet in people with PCOS (Polycystic Ovary Syndrome), run by Al-Mustansiriyah University at 1 site in Iraq.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Iraq. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Ezrin (time frame: At baseline after one month of treatment). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jul 2026.