Polycystic Ovary SyndromePhase 4NCT03644212
Vitamin D Increases Serum Levels of the Soluble Receptor for Advanced Glycation End Products in Women With PCOS
A Phase 4 study testing Vitamin D3 in people with Polycystic Ovary Syndrome and Vitamin D Deficiency, run by Maimonides Medical Center at 1 site in United States.
Trial summary
The purpose of this study is to investigate the mechanism that explain the beneficial clinical effect of vitamin D treatment in women with PCOS. Read more about this study
- Who is it for?
- Ages 16 to 48 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Polycystic Ovary Syndrome, Vitamin D Deficiency
- What is being tested?
- Vitamin D3
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 79 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2012to Oct 2013
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 16 to 48 years
- Women only
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Vitamin D deficient premenopausal women
Who cannot join
- Pregnant women
- Women during their postpartum period
- Breastfeeding women
- Women taking any kind of exogenous hormones
- Women receiving any form of oral vitamin D replacement
Trial locations and contacts
1 site in 1 country.
United States1 site
Maimonides Medical Center, OBGYN clinic
Brooklyn, New York, 11219
About this study
The purpose of this study is to investigate the mechanism that explain the beneficial clinical effect of vitamin D treatment in women with PCOS.
Read the detailed description
Seventy-nine women with (n=22) or without (control; n=57) PCOS who were diagnosed with vitamin D deficiency were enrolled. Sixty-three women were treated with oral vit D3 for 8 weeks (16 with PCOS and 47 controls) and 16 women were not treated (6 with PCOS and 10 controls). Serum 25 hydroxy-vitamin D (25 OH-D), sRAGE, and AMH concentrations were measured at baseline and after vit D3 supplementation in the treated group, and 8 weeks apart in the non-treated group. Paired t-test, Wilcoxon signed-rank test, and Pearson correlation were used as appropriate.
Main outcome measure: Changes in AMH concentrations following vit D3 replacement.
- Conditions
- Polycystic Ovary Syndrome, Vitamin D Deficiency
- Being tested
- Vitamin D3
- Keywords
- Polycystic Ovary Syndrome, Vitamin D, Anti Mullerian Hormone, Soluble receptor for Advanced Glycation End Products
- Medical subject headings
- Polycystic Ovary Syndrome, Vitamin D Deficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vitamin D3Drug
Also called Vitamin
Sixty-three vitamin D deficient women (16 with PCOS and 47 without PCOS) were supplemented with 50.000 IU of oral vitamin D3, once weekly for 8 weeks. Serum 25-hydroxyvitamin D (25OH-D), sRAGE and AMH levels were checked before and after treatment.
| Study group | Role | What they receive |
|---|---|---|
| Vitamin D treatment | Active comparator | Sixty-three vitamin D deficient women (16 with PCOS and 47 without PCOS) were supplemented with 50.000 IU of oral vitamin D3, once weekly for 8 weeks. Serum 25-hydroxyvitamin D (25OH-D), sRAGE and AMH levels were checked before and after treatment. Receives: Drug: Vitamin D3 |
| Non treated | No intervention | Sixteen vitamin D deficient women (6 with PCOS and 10 without PCOS) were not supplemented vitamin D3. Serum 25-hydroxyvitamin D (25OH-D), sRAGE and AMH levels were checked before and after treatment. |
What is being measured
The primary outcome is the main question the study is designed to answer.
AMH Levels in Women With PCOS
AMH measured by serum analysis
Measured: 8 weeks after completing vitamin D treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Aug 2018
- Study startJul 2012
- Primary completionSep 2013
- Study completionOct 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Polycystic Ovary SyndromeStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 79 participants (actual)
Sponsor and investigators
- Lead sponsor
- Maimonides Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Mohamad Irani, MD, Study director, Maimonides Medical Center, Brooklyn, NY, USAZaher Merhi, MD, Principal investigator, University of Vermont College of Medicine, Burlington, VT, USA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03644212
- Sponsor's protocol ID
- 12/07/XA03
- Status last verified
- Dec 2019
- First submitted
- 4 May 2013
- Last updated
- 13 Jan 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 13 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Vitamin D Increases Serum Levels of the Soluble Receptor for Advanced Glycation End Products in Women With PCOS
- ClinicalTrials.gov ID
- NCT03644212
- Acronym / sponsor ID
- 12/07/XA03
- Conditions
- Polycystic Ovary Syndrome, Vitamin D Deficiency
- Keywords
- Polycystic Ovary Syndrome, Vitamin D, Anti Mullerian Hormone, Soluble receptor for Advanced Glycation End Products
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 79 participants (actual)
- Lead sponsor
- Maimonides Medical CenterUniversity, hospital or other
- Study start
- Jul 2012
- Primary completion
- Sep 2013 (actual)
- Study completion
- Oct 2013 (actual)
- First posted
- 23 Aug 2018 (actual)
- Results
- Posted 13 Jan 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to investigate the mechanism that explain the beneficial clinical effect of vitamin D treatment in women with PCOS.
Detailed description
Seventy-nine women with (n=22) or without (control; n=57) PCOS who were diagnosed with vitamin D deficiency were enrolled. Sixty-three women were treated with oral vit D3 for 8 weeks (16 with PCOS and 47 controls) and 16 women were not treated (6 with PCOS and 10 controls). Serum 25 hydroxy-vitamin D (25 OH-D), sRAGE, and AMH concentrations were measured at baseline and after vit D3 supplementation in the treated group, and 8 weeks apart in the non-treated group. Paired t-test, Wilcoxon signed-rank test, and Pearson correlation were used as appropriate.
Main outcome measure: Changes in AMH concentrations following vit D3 replacement.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Vitamin D treatment | Active comparator | Drug: Vitamin D3Sixty-three vitamin D deficient women (16 with PCOS and 47 without PCOS) were supplemented with 50.000 IU of oral vitamin D3, once weekly for 8 weeks. Serum 25-hydroxyvitamin D (25OH-D), sRAGE and AMH levels were checked before and after treatment. |
| Non treated | No intervention | –Sixteen vitamin D deficient women (6 with PCOS and 10 without PCOS) were not supplemented vitamin D3. Serum 25-hydroxyvitamin D (25OH-D), sRAGE and AMH levels were checked before and after treatment. |
Who may qualify
- Ages
- 16 to 48 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- Vitamin D deficient premenopausal women
Key exclusion criteria (5 listed)
- Pregnant women
- Women during their postpartum period
- Breastfeeding women
- Women taking any kind of exogenous hormones
- Women receiving any form of oral vitamin D replacement
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 D3Also: VitaminSixty-three vitamin D deficient women (16 with PCOS and 47 without PCOS) were supplemented with 50.000 IU of oral vitamin D3, once weekly for 8 weeks. Serum 25-hydroxyvitamin D (25OH-D), sRAGE and AMH levels were checked before and after treatment. | Drug | Vitamin D treatment |
Primary outcome
AMH Levels in Women With PCOS
Time frame: 8 weeks after completing vitamin D treatment
AMH measured by serum analysis
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jan 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Mohamad Irani, MD study director
Maimonides Medical Center, Brooklyn, NY, USA
Zaher Merhi, MD principal investigator
University of Vermont College of Medicine, Burlington, VT, USA
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 D3 in people with Polycystic Ovary Syndrome and Vitamin D Deficiency, run by Maimonides Medical Center at 1 site in United States.
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 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 13 Jan 2020. 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 United States. 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 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?
Yes. Results are posted in the registry (first posted 13 Jan 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
AMH Levels in Women With PCOS (time frame: 8 weeks after completing vitamin D treatment). 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 13 Jan 2020.