Polycystic Ovary SyndromePhase 1/2NCT00907153
Vitamin D for the Treatment of Women With Polycystic Ovary Syndrome (PCOS)
A Phase 1/2 study testing Vitamin D in people with Polycystic Ovary Syndrome, run by Milton S. Hershey Medical Center at 1 site in United States.
Trial summary
The purpose of this study is to determine if vitamin D will improve insulin resistance, inflammation, and overall well-being in women with PCOS. 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 D
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 36 participants
- Where
- 1 siteUnited States
- Study dates
- May 2009to Sep 2014
- Phase
- Phase 1/2
- 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 18 to 45 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Diagnosis of PCOS based on:
- Eight or fewer menstrual periods per year or spontaneous intermenstrual periods of greater than or equal to 45 days, and
- Elevated testosterone levels
Who cannot join
- Current Pregnancy or Nursing
- Elevated calcium
- Kidney Stones or kidney disease
- Current use of vitamin D (other than a multivitamin)
- Use of metformin or other insulin sensitizing drugs in the last 3 months
- Elevated prolactin or untreated thyroid disease
- Diabetes, Liver disease, Heart disease, or other serious medical condition
Trial locations and contacts
1 site in 1 country.
United States1 site
Penn State College of Medicine, Penn State Milton S Hershey Medical Center
Hershey, Pennsylvania, 17033
About this study
Official title: Vitamin D Supplementation in Polycystic Ovary Syndrome: a Randomized Controlled Trial.
The purpose of this study is to determine if vitamin D will improve insulin resistance, inflammation, and overall well-being in women with PCOS.
Read the detailed description
As many cells throughout the body possess the vitamin D receptor, adequate vitamin D levels may be essential for multiple physiologic functions. In recent years, vitamin D insufficiency has been linked to insulin resistance, inflammation, poor psychological health, obesity, type 2 diabetes, and cardiovascular disease - these are also commonly found in women with Polycystic Ovary syndrome (PCOS). We believe that vitamin D insufficiency contributes to insulin resistance, inflammation, and psychological distress in women with PCOS. These adverse effects may ultimately increase the risk for serious long-term complications in PCOS, including type 2 diabetes and cardiovascular disease. The key objectives of this research study are to determine the effects of vitamin D supplementation on insulin resistance, inflammation, mood and overall well-being in women with PCOS.
The protocol has been modified by adding the following specific aim: To compare vascular function in healthy age and BMI similar matched women to PCOS women pre-treatment. Our hypothesis is that PCOS women will have greater attenuations in retinal vascular reactivity compared to healthy control women, demonstrating poorer endothelial function. We are currently recruiting healthy women who are age and BMI similar to the PCOS women and measure their retinal vascular reactivity for comparisons to the PCOS women's pre-treatment vascular reactivity. These healthy women will only have a baseline visit in which retinal vascular reactivity will be measured. They will not be enrolled in the placebo or Vitamin D randomization process as described above.
- Conditions
- Polycystic Ovary Syndrome
- Being tested
- Vitamin D, Placebo
- Keywords
- Polycystic Ovary Syndrome, Vitamin D, Insulin resistance, Inflammation
- Medical subject headings
- Polycystic Ovary Syndrome, Insulin Resistance, Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vitamin DDietary supplement
Vitamin D 300 mcg by mouth once daily for 12 weeks
PlaceboDrug
Placebo by mouth once daily for 12 weeks
| Study group | Role | What they receive |
|---|---|---|
| Vitamin D | Experimental | Not described Receives: Dietary Supplement: Vitamin D |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change From Baseline in Mean Quantitative Insulin Sensitivity Check Index (QUICKI)
Quantitative insulin sensitivity check index (QUICKI) is a validated measure of insulin sensitivity based on fasting insulin and glucose. Quantitative insulin sensitivity check index (QUICKI) = 1/[log(I(0)) + log(G(0))]).
Measured: Baseline and 12 weeks
Secondary outcomes (15)
Change From Baseline in Mean High Sensitive C-reactive Protein (hsCRP)
High sensitive C-reactive protein (hsCRP) was assessed as a measure of inflammation.
Measured: Baseline and 12 weeks
Change From Baseline in Mean Systolic Blood Pressure
Blood pressure was measured in the right arm in the sitting position after a 15-minute rest.
Measured: Baseline and 12 weeks
Change From Baseline in Mean Diastolic Blood Pressure
Blood pressure was measured in the right arm in the sitting position after a 15-minute rest.
Measured: Baseline and 12 weeks
Change From Baseline in Mean Fasting Glucose
Glucose was assessed after 12 hours of fasting.
Measured: Baseline and 12 weeks
Change From Baseline in Mean Fasting Insulin
Insulin was assessed after 12 hours of fasting.
Measured: Baseline and 12 weeks
Change From Baseline in Mean 2-hour Glucose
Participants underwent a 75-gram oral glucose tolerance test, in which blood samples for glucose and insulin were obtained at 0 and 2 hours and used to calculate the insulin sensitivity index (ISI 0,120).
Measured: Baseline and 12 weeks
Change From Baseline in Mean 2-hour Insulin
Participants underwent a 75-gram oral glucose tolerance test, in which blood samples for glucose and insulin were obtained at 0 and 2 hours and used to calculate the insulin sensitivity index (ISI 0,120).
Measured: Baseline and 12 weeks
Change From Baseline in Mean Insulin Sensitivity Index (ISI 0,120)
Participants underwent a 75-g oral glucose tolerance test, in which blood samples for glucose and insulin were obtained at 0 and 120 minutes and used to calculate the insulin sensitivity index (ISI0,120). The ISI 0,120 = the glucose uptake rate divided by the mean plasma glucose divided by the log(mean serum insulin).
Measured: Baseline and 12 weeks
Change From Baseline in Mean Homeostatic Model Assessment of Insulin Resistance (HOMA-IR)
Homeostatic Model Assessment of Insulin Resistance (HOMA-IR) is a validated measure of insulin resistance based on fasting insulin and glucose. HOMA-IR is calculated as the product of fasting glucose and insulin divided by 22.5.
Measured: Baseline and 12 weeks
Change From Baseline in Mean Total Cholesterol
Lipid profile was assessed after 12 hours of fasting.
Measured: Baseline and 12 weeks
Change From Baseline in Mean HDL Cholesterol
Lipid profile was assessed after 12 hours of fasting.
Measured: Baseline and 12 weeks
Change From Baseline in Mean LDL Cholesterol
Lipid profile was assessed after 12 hours of fasting.
Measured: Baseline and 12 weeks
Change From Baseline in Mean Triglycerides
Lipid profile was assessed after 12 hours of fasting.
Measured: Baseline and 12 weeks
Change From Baseline in Mean Total Testosterone
Total and free testosterone levels were assessed from blood samples to evaluate effects on hyperandrogenemia in PCOS.
Measured: Baseline and 12 weeks
Change From Baseline in Mean Free Testosterone
Total and free testosterone levels were assessed from blood samples to evaluate effects on hyperandrogenemia in PCOS.
Measured: Baseline and 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 May 2009 (estimated)
- Study startMay 2009
- Primary completionFeb 2014
- Study completionSep 2014
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.
- 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 Milton S. Hershey Medical CenterThe 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 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Milton S. Hershey Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nazia Raja-Khan, Milton S. Hershey Medical Center
- Investigators
- Nazia Raja-Khan, M.D., Principal investigator, Penn State College of Medicine, Penn State Milton S. Hershey Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00907153
- Sponsor's protocol ID
- 29714
- Status last verified
- Nov 2017
- First submitted
- 21 May 2009
- Last updated
- 19 Dec 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Raja-Khan N, Shah J, Stetter CM, Lott ME, Kunselman AR, Dodson WC, Legro RS. High-dose vitamin D supplementation and measures of insulin sensitivity in polycystic ovary syndrome: a randomized, controlled pilot trial. Fertil Steril. 2014 Jun;101(6):1740-6. doi: 10.1016/j.fertnstert.2014.02.021. Epub 2014 Mar 14.
PubMed 24636395
Study at a glance
From the registry record, last updated by the sponsor on 19 Dec 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Vitamin D Supplementation in Polycystic Ovary Syndrome: a Randomized Controlled Trial.
- ClinicalTrials.gov ID
- NCT00907153
- Acronym / sponsor ID
- 29714
- Conditions
- Polycystic Ovary Syndrome
- Keywords
- Polycystic Ovary Syndrome, Vitamin D, Insulin resistance, Inflammation
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Milton S. Hershey Medical CenterUniversity, hospital or other
- Study start
- May 2009
- Primary completion
- Feb 2014 (actual)
- Study completion
- Sep 2014 (actual)
- First posted
- 22 May 2009 (estimated)
- Results
- Posted 19 Dec 2017
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 determine if vitamin D will improve insulin resistance, inflammation, and overall well-being in women with PCOS.
Detailed description
As many cells throughout the body possess the vitamin D receptor, adequate vitamin D levels may be essential for multiple physiologic functions. In recent years, vitamin D insufficiency has been linked to insulin resistance, inflammation, poor psychological health, obesity, type 2 diabetes, and cardiovascular disease - these are also commonly found in women with Polycystic Ovary syndrome (PCOS). We believe that vitamin D insufficiency contributes to insulin resistance, inflammation, and psychological distress in women with PCOS. These adverse effects may ultimately increase the risk for serious long-term complications in PCOS, including type 2 diabetes and cardiovascular disease. The key objectives of this research study are to determine the effects of vitamin D supplementation on insulin resistance, inflammation, mood and overall well-being in women with PCOS.
The protocol has been modified by adding the following specific aim: To compare vascular function in healthy age and BMI similar matched women to PCOS women pre-treatment. Our hypothesis is that PCOS women will have greater attenuations in retinal vascular reactivity compared to healthy control women, demonstrating poorer endothelial function. We are currently recruiting healthy women who are age and BMI similar to the PCOS women and measure their retinal vascular reactivity for comparisons to the PCOS women's pre-treatment vascular reactivity. These healthy women will only have a baseline visit in which retinal vascular reactivity will be measured. They will not be enrolled in the placebo or Vitamin D randomization process as described above.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Vitamin D | Experimental | Dietary Supplement: Vitamin D |
| Placebo | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Diagnosis of PCOS based on:
Key exclusion criteria (7 listed)
- Current Pregnancy or Nursing
- Elevated calcium
- Kidney Stones or kidney disease
- Current use of vitamin D (other than a multivitamin)
- Use of metformin or other insulin sensitizing drugs in the last 3 months
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 300 mcg by mouth once daily for 12 weeks | Dietary supplement | Vitamin D |
| PlaceboPlacebo by mouth once daily for 12 weeks | Drug | Placebo |
Primary outcome
Change From Baseline in Mean Quantitative Insulin Sensitivity Check Index (QUICKI)
Time frame: Baseline and 12 weeks
Quantitative insulin sensitivity check index (QUICKI) is a validated measure of insulin sensitivity based on fasting insulin and glucose. Quantitative insulin sensitivity check index (QUICKI) = 1/[log(I(0)) + log(G(0))]).
15 secondary outcomes
Change From Baseline in Mean High Sensitive C-reactive Protein (hsCRP)
Time frame: Baseline and 12 weeks
Change From Baseline in Mean Systolic Blood Pressure
Time frame: Baseline and 12 weeks
Change From Baseline in Mean Diastolic Blood Pressure
Time frame: Baseline and 12 weeks
Change From Baseline in Mean Fasting Glucose
Time frame: Baseline and 12 weeks
Change From Baseline in Mean Fasting Insulin
Time frame: Baseline and 12 weeks
Change From Baseline in Mean 2-hour Glucose
Time frame: Baseline and 12 weeks
Change From Baseline in Mean 2-hour Insulin
Time frame: Baseline and 12 weeks
Change From Baseline in Mean Insulin Sensitivity Index (ISI 0,120)
Time frame: Baseline and 12 weeks
Change From Baseline in Mean Homeostatic Model Assessment of Insulin Resistance (HOMA-IR)
Time frame: Baseline and 12 weeks
Change From Baseline in Mean Total Cholesterol
Time frame: Baseline and 12 weeks
Change From Baseline in Mean HDL Cholesterol
Time frame: Baseline and 12 weeks
Change From Baseline in Mean LDL Cholesterol
Time frame: Baseline and 12 weeks
Change From Baseline in Mean Triglycerides
Time frame: Baseline and 12 weeks
Change From Baseline in Mean Total Testosterone
Time frame: Baseline and 12 weeks
Change From Baseline in Mean Free Testosterone
Time frame: Baseline and 12 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Dec 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 24636395Raja-Khan N, Shah J, Stetter CM, Lott ME, Kunselman AR, Dodson WC, Legro RS. High-dose vitamin D supplementation and measures of insulin sensitivity in polycystic ovary syndrome: a randomized, controlled pilot trial. Fertil Steril. 2014 Jun;101(6):1740-6. doi: 10.1016/j.fertnstert.2014.02.021. Epub 2014 Mar 14.
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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.
Nazia Raja-Khan, M.D. principal investigator
Penn State College of Medicine, Penn State Milton S. Hershey Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Vitamin D in people with Polycystic Ovary Syndrome, run by Milton S. Hershey 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 3 inclusion and 7 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 19 Dec 2017. 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. 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 combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
Yes. Results are posted in the registry (first posted 19 Dec 2017). 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?
Change From Baseline in Mean Quantitative Insulin Sensitivity Check Index (QUICKI) (time frame: Baseline and 12 weeks). 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 NCT00907153, 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 19 Dec 2017.