PCOSPhase 4PCOvit-DNCT03898934
Vitamin D Supplementation in PCOS Patients
A Phase 4 study testing Vitamin D in people with PCOS, run by Tanta University at 1 site in Egypt.
Trial summary
To assess whether Vitamin D supplementations for patients with polycystic ovary syndrome in conjunction with clomiphene citrate are beneficial or not Read more about this study
- Who is it for?
- Ages 20 to 35 years, women only
- Conditions the study is for
- PCOS
- What is being tested?
- Vitamin D
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 170 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Apr 2019to 31 Mar 2022
- Phase
- Phase 4
- 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 20 to 35 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- PCOS
- Infertile
- Vitamin D deficient
Who cannot join
- Age less than 20 and more than 35
- Non PCOS patients
- Obese patients
- Previous ovarian surgery
- Previous oophrectomy of one ovary
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Dose Vitamin-D Supplementation Affect Reproductive Outcomes in Patients With Polycystic Ovary Syndrome?
To assess whether Vitamin D supplementations for patients with polycystic ovary syndrome in conjunction with clomiphene citrate are beneficial or not
Read the detailed description
This study is double blinded randomized controlled study conducted at Tanta University hospitals in the period from April 2019 to March 2022. Patients and methods: One hundred twelve patients were recruited and randomly allocated into 2 groups; study group with Vitamin D supplementation and control group without Vitamin D supplementation.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vitamin DDrug
receive 6000iu daily for 8 weeks
Placebo Oral TabletDrug
placebo for the same period
| Study group | Role | What they receive |
|---|---|---|
| Vitamin D group | Experimental | These patients will receive 6000IU daily for 8 weeks then 2000IU maintenance till pregnancy or end of study Receives: Drug: Vitamin D |
| Placebo group | Placebo comparator | These group will receive placebo for the same periods of study group Receives: Drug: Placebo Oral Tablet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ovulation rate
Number of mature follicles obtained
Measured: 3 months
Pregnancy rate
Number of patients who get pregnant
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Apr 2019
- Study start1 Apr 2019
- Primary completion30 Mar 2022
- Study completion31 Mar 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PCOSStudies of the same condition, open and under way.
- More trials run by Tanta UniversityThe 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The 2 groups will be treated at the same time
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 170 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tanta University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ayman S Dawood, MD, Tanta University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03898934
- Sponsor's protocol ID
- PCOvit-D
- Acronym
- PCOvit-D
- Status last verified
- Apr 2022
- First submitted
- 30 Mar 2019
- Last updated
- 5 May 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The investigators will share results
Study at a glance
From the registry record, last updated by the sponsor on 5 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dose Vitamin-D Supplementation Affect Reproductive Outcomes in Patients With Polycystic Ovary Syndrome?
- ClinicalTrials.gov ID
- NCT03898934
- Acronym / sponsor ID
- PCOvit-D / PCOvit-D
- Conditions
- PCOS
- Keywords
- PCOS, Vitamin D, Supplementation, Ovulation, Pregnancy
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 170 participants (actual)
- Lead sponsor
- Tanta UniversityUniversity, hospital or other
- Study start
- 1 Apr 2019 (actual)
- Primary completion
- 30 Mar 2022 (actual)
- Study completion
- 31 Mar 2022 (actual)
- First posted
- 2 Apr 2019 (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.
To assess whether Vitamin D supplementations for patients with polycystic ovary syndrome in conjunction with clomiphene citrate are beneficial or not
Detailed description
This study is double blinded randomized controlled study conducted at Tanta University hospitals in the period from April 2019 to March 2022. Patients and methods: One hundred twelve patients were recruited and randomly allocated into 2 groups; study group with Vitamin D supplementation and control group without Vitamin D supplementation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
- Model description
- The 2 groups will be treated at the same time
| Arm | Type | Receives |
|---|---|---|
| Vitamin D group | Experimental | Drug: Vitamin DThese patients will receive 6000IU daily for 8 weeks then 2000IU maintenance till pregnancy or end of study |
| Placebo group | Placebo comparator | Drug: Placebo Oral TabletThese group will receive placebo for the same periods of study group |
Who may qualify
- Ages
- 20 to 35 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- PCOS
- Infertile
- Vitamin D deficient
Key exclusion criteria (5 listed)
- Age less than 20 and more than 35
- Non PCOS patients
- Obese patients
- Previous ovarian surgery
- Previous oophrectomy of one ovary
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 Dreceive 6000iu daily for 8 weeks | Drug | Vitamin D group |
| Placebo Oral Tabletplacebo for the same period | Drug | Placebo group |
Primary outcome
Ovulation rate
Time frame: 3 months
Number of mature follicles obtained
Pregnancy rate
Time frame: 3 months
Number of patients who get pregnant
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 5 May 2022.
- Individual participant dataSharing planned: Yes. The investigators will share results
Related trials for PCOS
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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. 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 Phase 4 study testing Vitamin D in people with PCOS, run by Tanta University at 1 site in Egypt.
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 3 inclusion and 5 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 5 May 2022. 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 Egypt. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Ovulation rate (time frame: 3 months). The study lists 2 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 5 May 2022.