Polycystic Ovary SyndromeNCT02513381
Effect of Vitamin D on Hormonal, Metabolic and Cardiovascular Risk Factors in Patients With Polycystic Ovary Syndrome
A study testing Vitamin D3, 3200IU in people with Polycystic Ovary Syndrome, run by Hull University Teaching Hospitals NHS Trust at 1 site in United Kingdom.
Trial summary
This is a double blind randomised placebo-controlled study involving women with polycystic ovary syndrome (PCOS). The patients will be randomised either to Vitamin D 3200 IU or placebo for three months. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Polycystic Ovary Syndrome
- What is being tested?
- Vitamin D3, 3200IU
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Jul 2015to Nov 2016
- 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 to 45 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Caucasian women, aged 18-45 years, with confirmed diagnosis of PCOS based on all three diagnostic criteria of the Rotterdam consensus [21].
- Irregular periods with raised FAI
- Vitamin D < 50 nmol/L.
Who cannot join
- Non-classical 21-hydroxylase deficiency, hyperprolactinaemia, Cushing's disease and androgen-secreting tumours will be excluded by appropriate tests if clinically indicated.
- Any concurrent illness including type 2 diabetes, subjects who are on any medication (including medications that interfere with calceotrophic hormones) for the preceding 6 months.
- Women planning to conceive.
- Women who are using any oral or implantable contraceptives or any other treatments likely to affect ovarian function, insulin sensitivity or lipids for at least 3 months before entering the study. Stable dose of metformin for 3 months is allowed. Subjects will be advised to use barrier contraception during the study period.
- eGFR<60.
- Hypersensitivity to vitamin D or any of the excipients in the product.
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- Peanut or soya allergy.
- Nephrolithiasis.
- Diseases or conditions resulting in hypercalcaemia and/or hypercalciuria.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Michael White Centre for Diabetes and Endocrinology
Hull, East Yorkshire, HU3 2RW
About this study
Official title: The Effect of Colecalciferol (Vitamin D) on Hormonal, Metabolic and Cardiovascular Risk Factors in Patients With Polycystic Ovary Syndrome (PCOS) - a Double Blind Randomised Placebo-controlled Study
This is a double blind randomised placebo-controlled study involving women with polycystic ovary syndrome (PCOS). The patients will be randomised either to Vitamin D 3200 IU or placebo for three months. The main hypothesis of this study is "Vitamin D improves hormonal, metabolic and cardiovascular risk markers in women with PCOS".
Read the detailed description
Polycystic ovary syndrome (PCOS) is a very common condition in women which could present with irregular periods, excessive hair growth on body, acne and cysts in the ovaries. PCOS is also associated with increased risk of problems later in life like diabetes, high cholesterol levels and heart disease. One of the risk factors for having increased incidence of such problems in PCOS patients could be low vitamin D levels as many women with polycystic ovary syndrome (PCOS) are vitamin D deficient. Vitamin D supplementation may have a beneficial effect on insulin levels and fat around the abdomen. It has been seen in previous research studies that low level of vitamin D is related to a greater risk of diabetes and heart disease. Low vitamin D levels are also associated with fat in the liver. The amount of fat in the liver is a sign of early liver disease. So, in this study the investigators want to supplement women having PCOS and vitamin D deficiency with vitamin D (3,200 IU) and examine the effects on hormones related to PCOS and risk factors for diabetes and heart disease in them.
- Conditions
- Polycystic Ovary Syndrome
- Being tested
- Vitamin D3, 3200IU, Placebo
- 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 D3, 3200IUOther
Each participant will receive either Vitamin D3, 3200IU or Placebo daily for three months.
PlaceboOther
Each participant will receive either Vitamin D3, 3200IU or Placebo daily for three months.
| Study group | Role | What they receive |
|---|---|---|
| Vitamin D3, 3200IU | Active comparator | Each participant will receive either Vitamin D3, 3200IU or Placebo daily for three months. Receives: Other: Vitamin D3, 3200IU |
| Placebo | Placebo comparator | Each participant will receive either Vitamin D3, 3200IU or Placebo daily for three months. Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cardiovascular risk assessment by hs-CRP, HOMA (fasting glucose & insulin) and fasting lipid profile
Measured: Three months supplementation with Vitamin D3 3200IU or placebo
Secondary outcomes (3)
Hormonal parameters including testosterone, SHBG and FAI.
Measured: Three months supplementation with Vitamin D3 3200IU or placebo
Inflammatory marker hs-CRP
Measured: Three months supplementation with Vitamin D3 3200IU or placebo
Endothelial function by EndoPAT
Measured: Three months supplementation with Vitamin D3 3200IU or placebo
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jul 2015 (estimated)
- Study startJul 2015
- Primary completionNov 2016
- Study completionNov 2016
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.
- 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hull University Teaching Hospitals NHS Trust
- Sponsor type
- Other government
- Collaborators
- University of Hull
- Responsible party
- Sponsor
- Investigators
- Thozhukat Sathyapalan, MD, FRCP, Principal investigator, University of Hull
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02513381
- Sponsor's protocol ID
- 14/YH/1125
- Status last verified
- Jul 2019
- First submitted
- 23 Jul 2015
- Last updated
- 16 Jul 2019
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Javed Z, Papageorgiou M, Deshmukh H, Kilpatrick ES, Mann V, Corless L, Abouda G, Rigby AS, Atkin SL, Sathyapalan T. A Randomized, Controlled Trial of Vitamin D Supplementation on Cardiovascular Risk Factors, Hormones, and Liver Markers in Women with Polycystic Ovary Syndrome. Nutrients. 2019 Jan 17;11(1):188. doi: 10.3390/nu11010188.
PubMed 30658483
Study at a glance
From the registry record, last updated by the sponsor on 16 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Colecalciferol (Vitamin D) on Hormonal, Metabolic and Cardiovascular Risk Factors in Patients With Polycystic Ovary Syndrome (PCOS) - a Double Blind Randomised Placebo-controlled Study
- ClinicalTrials.gov ID
- NCT02513381
- Acronym / sponsor ID
- 14/YH/1125
- Conditions
- Polycystic Ovary Syndrome
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Hull University Teaching Hospitals NHS TrustOther government
- Collaborators
- University of Hull
- Study start
- Jul 2015
- Primary completion
- Nov 2016 (actual)
- Study completion
- Nov 2016 (actual)
- First posted
- 31 Jul 2015 (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.
This is a double blind randomised placebo-controlled study involving women with polycystic ovary syndrome (PCOS). The patients will be randomised either to Vitamin D 3200 IU or placebo for three months. The main hypothesis of this study is "Vitamin D improves hormonal, metabolic and cardiovascular risk markers in women with PCOS".
Detailed description
Polycystic ovary syndrome (PCOS) is a very common condition in women which could present with irregular periods, excessive hair growth on body, acne and cysts in the ovaries. PCOS is also associated with increased risk of problems later in life like diabetes, high cholesterol levels and heart disease. One of the risk factors for having increased incidence of such problems in PCOS patients could be low vitamin D levels as many women with polycystic ovary syndrome (PCOS) are vitamin D deficient. Vitamin D supplementation may have a beneficial effect on insulin levels and fat around the abdomen. It has been seen in previous research studies that low level of vitamin D is related to a greater risk of diabetes and heart disease. Low vitamin D levels are also associated with fat in the liver. The amount of fat in the liver is a sign of early liver disease. So, in this study the investigators want to supplement women having PCOS and vitamin D deficiency with vitamin D (3,200 IU) and examine the effects on hormones related to PCOS and risk factors for diabetes and heart disease in them.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Vitamin D3, 3200IU | Active comparator | Other: Vitamin D3, 3200IUEach participant will receive either Vitamin D3, 3200IU or Placebo daily for three months. |
| Placebo | Placebo comparator | Other: PlaceboEach participant will receive either Vitamin D3, 3200IU or Placebo daily for three months. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Caucasian women, aged 18-45 years, with confirmed diagnosis of PCOS based on all three diagnostic criteria of the Rotterdam consensus [21].
- Irregular periods with raised FAI
- Vitamin D < 50 nmol/L.
Key exclusion criteria (9 listed)
- Non-classical 21-hydroxylase deficiency, hyperprolactinaemia, Cushing's disease and androgen-secreting tumours will be excluded by appropriate tests if clinically indicated.
- Any concurrent illness including type 2 diabetes, subjects who are on any medication (including medications that interfere with calceotrophic hormones) for the preceding 6 months.
- Women planning to conceive.
- Women who are using any oral or implantable contraceptives or any other treatments likely to affect ovarian function, insulin sensitivity or lipids for at least 3 months before entering the study. Stable dose of metformin for 3 months is allowed. Subjects will be advised to use barrier contraception during the study period.
- eGFR<60.
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 D3, 3200IUEach participant will receive either Vitamin D3, 3200IU or Placebo daily for three months. | Other | Vitamin D3, 3200IU |
| PlaceboEach participant will receive either Vitamin D3, 3200IU or Placebo daily for three months. | Other | Placebo |
Primary outcome
Cardiovascular risk assessment by hs-CRP, HOMA (fasting glucose & insulin) and fasting lipid profile
Time frame: Three months supplementation with Vitamin D3 3200IU or placebo
3 secondary outcomes
Hormonal parameters including testosterone, SHBG and FAI.
Time frame: Three months supplementation with Vitamin D3 3200IU or placebo
Inflammatory marker hs-CRP
Time frame: Three months supplementation with Vitamin D3 3200IU or placebo
Endothelial function by EndoPAT
Time frame: Three months supplementation with Vitamin D3 3200IU or placebo
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 Jul 2019.
- Results publication: PubMed 30658483Javed Z, Papageorgiou M, Deshmukh H, Kilpatrick ES, Mann V, Corless L, Abouda G, Rigby AS, Atkin SL, Sathyapalan T. A Randomized, Controlled Trial of Vitamin D Supplementation on Cardiovascular Risk Factors, Hormones, and Liver Markers in Women with Polycystic Ovary Syndrome. Nutrients. 2019 Jan 17;11(1):188. doi: 10.3390/nu11010188.
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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.
Thozhukat Sathyapalan, MD, FRCP principal investigator
University of Hull
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 D3, 3200IU in people with Polycystic Ovary Syndrome, run by Hull University Teaching Hospitals NHS Trust at 1 site in United Kingdom.
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 9 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 Jul 2019. 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 Kingdom. 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?
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?
Cardiovascular risk assessment by hs-CRP, HOMA (fasting glucose & insulin) and fasting lipid profile (time frame: Three months supplementation with Vitamin D3 3200IU or placebo). 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 NCT02513381, 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 16 Jul 2019.