PCOSPhase 2PCOSDNCT02656121
Correction of Vitamin D Deficiency and Its Effect on Ovulation Induction in Women With PCOS (VIDEO): A Feasibility RCT
A Phase 2 study testing Vitamin D and Ovulatory Agent in people with PCOS, run by Ain Shams University at 1 site in Egypt.
Trial summary
Recently, a special emphasis has recently been directed to the potential role of vitamin D and some regulatory peptides (e.g. adipokines and follistatin) and their associated metabolic roles and genetic factors in the development of PCOS and its related co-morbidities. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- PCOS
- What is being tested?
- Vitamin D and Ovulatory Agent
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 1 siteEgypt
- Study dates
- Feb 2016to Nov 2018
- Phase
- Phase 2
- 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 to 45 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- diagnosed PCOS cases according to the National Institute of Health criteria (NIH consensus criteria) and Rotterdam criteria
Who cannot join
- 1- PCOS patients not in child bearing age; less than 18 years or more than 45 years.
- 2- Patients with congenital adrenal hyperplasia, androgen-secreting tumors, Cushing's syndrome, hyperprolactinemia and virilizing ovarian or adrenal tumors.
- 3- PCOS patients with any other medical illness. 4- PCOS patients already on vitamin D supplements.
Trial locations and contacts
1 site in 1 country.
About this study
Recently, a special emphasis has recently been directed to the potential role of vitamin D and some regulatory peptides (e.g. adipokines and follistatin) and their associated metabolic roles and genetic factors in the development of PCOS and its related co-morbidities. The aim of this study was to assess the feasibility of conducting a pragmatic RCT assessing the effectiveness of adopting a protocol of screening for and correcting Vitamin D deficiency in women with PCOS seeking fertility treatment in a low/middle income care (LMIC) setting
Read the detailed description
Research question:
In PCOS patients, is there any effect of vitamin D testing and correction on ovulation induction in women with PCOS?
Research hypothesis:
There is effect of testing and correcting vitamin D status as regard ovulation in patients with PCOS
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vitamin DDrug
Also called Vidrop®, Medical Union Pharmaceuticals, Egypt
6000 IU of vitamin D3
Ovulatory AgentDrug
Also called Clomiphene Citrate for induction of ovulation
only Clomophine Citrate
| Study group | Role | What they receive |
|---|---|---|
| Vitamin D | Experimental | 1st subgroup will be tested and treated with vitamin D together with Clomiphene Citrate for induction of ovulation Receives: Drug: Vitamin D; Drug: Ovulatory Agent |
| control | Active comparator | 2nd subgroup will be treated with Clomophene Citrate only Receives: Drug: Ovulatory Agent |
What is being measured
The primary outcome is the main question the study is designed to answer.
cumulative clomiphene citrate-induced ovulation rates
Ultrasound Folliculometry was performed every other day starting on the 10th day of the induction cycle. Until, at least, one follicle reached 18mm in diameter
Measured: 6 months
Secondary outcomes (2)
Cumlative clinical pregnancy rate
detection of fetal heart activity detected by transvaginal ultrasound
Measured: 6 months
median ovulating dose of clomiphene citrate
Dose required
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jan 2016 (estimated)
- Study startFeb 2016
- Primary completionNov 2018
- Study completionNov 2018
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 Ain Shams 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 300 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed Mohamed El Kotb Abdel Fattah, Ain Shams University
- Investigators
- Ahmed M kotb, MD, Principal investigator, Ain Shams University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02656121
- Sponsor's protocol ID
- PCO
- Acronym
- PCOSD
- Status last verified
- Nov 2018
- First submitted
- 12 Jan 2016
- Last updated
- 16 Nov 2018
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 16 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Correction of Vitamin D Deficiency and Its Effect on Ovulation Induction in Women With PCOS (VIDEO): A Feasibility RCT
- ClinicalTrials.gov ID
- NCT02656121
- Acronym / sponsor ID
- PCOSD / PCO
- Conditions
- PCOS
- Keywords
- PCOS, vitamin D
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 300 participants (actual)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- Feb 2016 (actual)
- Primary completion
- Nov 2018 (actual)
- Study completion
- Nov 2018 (actual)
- First posted
- 14 Jan 2016 (estimated)
- 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.
Recently, a special emphasis has recently been directed to the potential role of vitamin D and some regulatory peptides (e.g. adipokines and follistatin) and their associated metabolic roles and genetic factors in the development of PCOS and its related co-morbidities. The aim of this study was to assess the feasibility of conducting a pragmatic RCT assessing the effectiveness of adopting a protocol of screening for and correcting Vitamin D deficiency in women with PCOS seeking fertility treatment in a low/middle income care (LMIC) setting
Detailed description
Research question:
In PCOS patients, is there any effect of vitamin D testing and correction on ovulation induction in women with PCOS?
Research hypothesis:
There is effect of testing and correcting vitamin D status as regard ovulation in patients with PCOS
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Vitamin D | Experimental | Drug: Vitamin D, Drug: Ovulatory Agent1st subgroup will be tested and treated with vitamin D together with Clomiphene Citrate for induction of ovulation |
| control | Active comparator | Drug: Ovulatory Agent2nd subgroup will be treated with Clomophene Citrate only |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- diagnosed PCOS cases according to the National Institute of Health criteria (NIH consensus criteria) and Rotterdam criteria
Key exclusion criteria (3 listed)
- 1- PCOS patients not in child bearing age; less than 18 years or more than 45 years.
- 2- Patients with congenital adrenal hyperplasia, androgen-secreting tumors, Cushing's syndrome, hyperprolactinemia and virilizing ovarian or adrenal tumors.
- 3- PCOS patients with any other medical illness. 4- PCOS patients already on vitamin D supplements.
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 DAlso: Vidrop®, Medical Union Pharmaceuticals, Egypt6000 IU of vitamin D3 | Drug | Vitamin D |
| Ovulatory AgentAlso: Clomiphene Citrate for induction of ovulationonly Clomophine Citrate | Drug | Vitamin D, control |
Primary outcome
cumulative clomiphene citrate-induced ovulation rates
Time frame: 6 months
Ultrasound Folliculometry was performed every other day starting on the 10th day of the induction cycle. Until, at least, one follicle reached 18mm in diameter
2 secondary outcomes
Cumlative clinical pregnancy rate
Time frame: 6 months
median ovulating dose of clomiphene citrate
Time frame: 6 months
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 16 Nov 2018.
- Individual participant dataSharing planned: Yes
Related trials for PCOS
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Efficacy of Ovarian Drilling Via vNOTES Laparoscopy in Patients With PCOS
PCOS (Polycystic Ovary Syndrome)
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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)
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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.
Ahmed M kotb, MD principal investigator
Ain Shams University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Vitamin D and Ovulatory Agent in people with PCOS, run by Ain Shams 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 1 inclusion and 3 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 16 Nov 2018. 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. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
cumulative clomiphene citrate-induced ovulation rates (time frame: 6 months). 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 16 Nov 2018.