Polycystic Ovary SyndromeNCT04650880
Effect of Vitamin D on Ovulation Rate in Women With Polycystic Ovary Syndrome
A study testing Vitamin D in people with Polycystic Ovary Syndrome and Anovulation, run by The University of Hong Kong at 3 sites in Hong Kong.
Trial summary
This is a randomized double-blind controlled trial on the effect of vitamin D supplementation to assess the ovulation rate of women with polycystic ovary syndrome (PCOS) and other reproductive, endocrine and metabolic outcomes after one year of treatment. Read more about this study
- Who is it for?
- Ages 18 to 40 years, women only
- Conditions the study is for
- Polycystic Ovary Syndrome, Anovulation
- What is being tested?
- Vitamin D
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 220 participants
- Where
- 3 sitesHong Kong
- Study dates
- 26 Jan 2021to 31 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 to 40 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Premenopausal
- Aged 18-40 years
- Irregular long menstrual cycles (>35 days)
- PCOS according to the Rotterdam criteria
- Agree for transvaginal ultrasound
Who cannot join
- Use of hormonal medication (including contraception) within 3 months prior to study inclusion, except the use of a progestogen to induce withdrawal bleeding every 3 months
- History of any medical condition or medications that may predispose to vitamin D sensitivity, altered vitamin D metabolism and/ or hypercalcemia, including active tuberculosis or current therapy for tuberculosis, sarcoidosis, history of renal/ ureteral stones, parathyroid disease, renal or liver failure or current use of anti-convulsants
- Use of insulin-sensitizing drugs, lipid lowering drugs or anti-hypertensive
- Anticipated to use the above medications in the coming one year
- Known type 2 diabetes mellitus
- Refusal to join the study
- Abnormal blood calcium level
- For those on supplements, we asked them to stop their own supplements.
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Hong Kong3 sites, 3 recruiting
- Recruiting
Kwong Wah Hospital
Hong Kong
Shui Fan Lai, MBBS, MRCOG, +852 35175183, lsf087@ha.org.hk
- Not yet recruiting
Princess Margaret Hospital
Hong Kong
Rebecca S.F. Wan, MBBS, MRCOG
- Recruiting
Queen Mary Hospital, University of Hong Kong
Hong Kong
Jennifer Ka Yee Ko, MBBS, 22554647, jenko@hku.hk
About this study
Official title: A Randomized Double-blind Controlled Trial on the Effect of Vitamin D on Ovulation Rate of Women With Polycystic Ovary Syndrome
This is a randomized double-blind controlled trial on the effect of vitamin D supplementation to assess the ovulation rate of women with polycystic ovary syndrome (PCOS) and other reproductive, endocrine and metabolic outcomes after one year of treatment.
Read the detailed description
The hypothesis is that vitamin D supplementation results in significant improvement in the ovulation rate of women with PCOS either spontaneously or with oral ovulation induction agent.
Anovulatory women with PCOS diagnosed by the Rotterdam criteria will be recruited.
Participants will be randomized to the (1) vitamin D group or (2) placebo group. Those in the vitamin D group will take vitamin D 50,000 IU/ week for 4 weeks, followed by 50,000IU once every 2 weeks for 52 weeks, whereas those in the placebo group will take placebo tablets with the same external appearance. Those who remain anovulatory after 6 months will be treated with a 6-month course of letrozole (2.5mg to 7.5mg for 5 days per cycle titrated according to response) for ovulation induction.
The primary outcome is the ovulation rate and will be compared between the 2 groups.
- Conditions
- Polycystic Ovary Syndrome, Anovulation
- Being tested
- Vitamin D, Placebo
- Medical subject headings
- Polycystic Ovary Syndrome, Anovulation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vitamin DDietary supplement
Vitamin D supplementation
PlaceboOther
Placebo tablets with the same external appearance
| Study group | Role | What they receive |
|---|---|---|
| Vitamin D | Active comparator | Vitamin D 50,000 IU/ week for 4 weeks, followed by 50,000 IU once every 2 weeks for 52 weeks Those who remain anovulatory after 6 months will be treated with a 6-month course of letrozole (2.5mg to 7.5mg for 5 days per cycle titrated according to response) for ovulation induction. Receives: Dietary Supplement: Vitamin D |
| Placebo | Placebo comparator | Placebo tablets with same external appearance for 52 weeks Those who remain anovulatory after 6 months will be treated with a 6-month course of letrozole (2.5mg to 7.5mg for 5 days per cycle titrated according to response) for ovulation induction. Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ovulation rate
Serum progesterone
Measured: 12 months
Secondary outcomes (10)
Change in serum 25(OH)D level
Serum 25(OH)D
Measured: 12 months
Pregnancy rate
Positive urine or serum hCG test
Measured: 12 months
Live birth rate
Delivery of a baby after 22 completed weeks of gestational age, or with birth weight of 500 grams if the gestation age is unknown, which shows evidence of life
Measured: 12 months
Change in serum anti-Mullerian hormone level
serum AMH level
Measured: 12 months
Change in antral follicle count
Antral follicle count measured by transvaginal/ transrectal ultrasound
Measured: 12 months
Androgen indices
serum androgen and androstenedione levels, SHBG
Measured: 12 months
Body mass index
Height in cm, weight in kg, to calculate the body mass index (kg/m^2)
Measured: 12 months
Change in waist and hip circumference
waist and hip circumference in cm
Measured: 12 months
Rate of diabetes mellitus/ impaired glucose intolerance
Measured by fasting and 2 hour glucose (post 75g OGTT)
Measured: 12 months
Change in systolic and diastolic blood pressure
Blood pressure
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Dec 2020
- Study start26 Jan 2021
- Primary completion31 Dec 2024 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Polycystic Ovary SyndromeStudies of the same condition, open and under way.
- More trials run by The University of Hong KongThe sponsor's other registered studies.
- 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
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 220 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The University of Hong Kong
- Sponsor type
- University, hospital or other
- Collaborators
- Kwong Wah Hospital, Princess Margaret Hospital, Hong Kong, Pamela Youde Nethersole Eastern Hospital, The Queen Elizabeth Hospital
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04650880
- Sponsor's protocol ID
- UW20-004
- Status last verified
- May 2024
- First submitted
- 19 Nov 2020
- Last updated
- 14 May 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: all IPD that underlie results in a publication
Publications
Ko JKY, Yung SSF, Lai SF, Wan RSF, Wong CKY, Wong K, Cheung CL, Ng EHY, Li RHW. Effect of vitamin D in addition to letrozole on the ovulation rate of women with polycystic ovary syndrome: protocol of a multicentre randomised double-blind controlled trial. BMJ Open. 2024 Apr 29;14(4):e070801. doi: 10.1136/bmjopen-2022-070801.
PubMed 38684265
Study at a glance
From the registry record, last updated by the sponsor on 14 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Double-blind Controlled Trial on the Effect of Vitamin D on Ovulation Rate of Women With Polycystic Ovary Syndrome
- ClinicalTrials.gov ID
- NCT04650880
- Acronym / sponsor ID
- UW20-004
- Conditions
- Polycystic Ovary Syndrome, Anovulation
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 220 participants (estimated)
- Lead sponsor
- The University of Hong KongUniversity, hospital or other
- Collaborators
- Kwong Wah Hospital, Princess Margaret Hospital, Hong Kong, Pamela Youde Nethersole Eastern Hospital, The Queen Elizabeth Hospital
- Study start
- 26 Jan 2021 (actual)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 3 Dec 2020 (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.
This is a randomized double-blind controlled trial on the effect of vitamin D supplementation to assess the ovulation rate of women with polycystic ovary syndrome (PCOS) and other reproductive, endocrine and metabolic outcomes after one year of treatment.
Detailed description
The hypothesis is that vitamin D supplementation results in significant improvement in the ovulation rate of women with PCOS either spontaneously or with oral ovulation induction agent.
Anovulatory women with PCOS diagnosed by the Rotterdam criteria will be recruited.
Participants will be randomized to the (1) vitamin D group or (2) placebo group. Those in the vitamin D group will take vitamin D 50,000 IU/ week for 4 weeks, followed by 50,000IU once every 2 weeks for 52 weeks, whereas those in the placebo group will take placebo tablets with the same external appearance. Those who remain anovulatory after 6 months will be treated with a 6-month course of letrozole (2.5mg to 7.5mg for 5 days per cycle titrated according to response) for ovulation induction.
The primary outcome is the ovulation rate and will be compared between the 2 groups.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Vitamin D | Active comparator | Dietary Supplement: Vitamin DVitamin D 50,000 IU/ week for 4 weeks, followed by 50,000 IU once every 2 weeks for 52 weeks Those who remain anovulatory after 6 months will be treated with a 6-month course of letrozole (2.5mg to 7.5mg for 5 days per cycle titrated according to response) for ovulation induction. |
| Placebo | Placebo comparator | Other: PlaceboPlacebo tablets with same external appearance for 52 weeks Those who remain anovulatory after 6 months will be treated with a 6-month course of letrozole (2.5mg to 7.5mg for 5 days per cycle titrated according to response) for ovulation induction. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Premenopausal
- Aged 18-40 years
- Irregular long menstrual cycles (>35 days)
- PCOS according to the Rotterdam criteria
- Agree for transvaginal ultrasound
Key exclusion criteria (8 listed)
- Use of hormonal medication (including contraception) within 3 months prior to study inclusion, except the use of a progestogen to induce withdrawal bleeding every 3 months
- History of any medical condition or medications that may predispose to vitamin D sensitivity, altered vitamin D metabolism and/ or hypercalcemia, including active tuberculosis or current therapy for tuberculosis, sarcoidosis, history of renal/ ureteral stones, parathyroid disease, renal or liver failure or current use of anti-convulsants
- Use of insulin-sensitizing drugs, lipid lowering drugs or anti-hypertensive
- Anticipated to use the above medications in the coming one year
- Known type 2 diabetes mellitus
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 DVitamin D supplementation | Dietary supplement | Vitamin D |
| PlaceboPlacebo tablets with the same external appearance | Other | Placebo |
Primary outcome
Ovulation rate
Time frame: 12 months
Serum progesterone
10 secondary outcomes
Change in serum 25(OH)D level
Time frame: 12 months
Pregnancy rate
Time frame: 12 months
Live birth rate
Time frame: 12 months
Change in serum anti-Mullerian hormone level
Time frame: 12 months
Change in antral follicle count
Time frame: 12 months
Androgen indices
Time frame: 12 months
Body mass index
Time frame: 12 months
Change in waist and hip circumference
Time frame: 12 months
Rate of diabetes mellitus/ impaired glucose intolerance
Time frame: 12 months
Change in systolic and diastolic blood pressure
Time frame: 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 May 2024.
- Derived from this study: PubMed 38684265Ko JKY, Yung SSF, Lai SF, Wan RSF, Wong CKY, Wong K, Cheung CL, Ng EHY, Li RHW. Effect of vitamin D in addition to letrozole on the ovulation rate of women with polycystic ovary syndrome: protocol of a multicentre randomised double-blind controlled trial. BMJ Open. 2024 Apr 29;14(4):e070801. doi: 10.1136/bmjopen-2022-070801.
- Individual participant dataSharing planned: Yes. all IPD that underlie results in a publication
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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.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Vitamin D in people with Polycystic Ovary Syndrome and Anovulation, run by The University of Hong Kong at 3 sites in Hong Kong.
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 5 inclusion and 8 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: looking for participants now, as of the sponsor's last update on 14 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Hong Kong. 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. Some participants in this study may receive a placebo. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Ovulation rate (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04650880, which also lists 1 linked publication.
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 14 May 2024.