Polycystic Ovary SyndromePhase 4NCT02460380
The Effects of Vitamin D on Angiogenic Factors in Women With Polycystic Ovary Syndrome
A Phase 4 study testing Vitamin D3 in people with Polycystic Ovary Syndrome and Vitamin D Deficiency, run by Maimonides Medical Center.
Trial summary
Polycystic Ovary Syndrome (PCOS) affects 5 to 10% of women of reproductive age. It is characterized by a cluster of hyperandrogenism, hyperinsulinemia, menstrual dysfunction, hirsutism and infertility. Read more about this study
- Who is it for?
- Ages 18 to 38 years, women only
- 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?
- Yes, some participants may receive a placebo
- How many people
- 93 participants
- Where
- No sites listed yet
- Study dates
- Oct 2013to Mar 2015
- 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 18 to 38 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Women with PCOS who have vitamin D deficiency (serum 25-hydroxyvitamin D<20 ng/mL)
Who cannot join
- Pregnant, postpartum, breast feeding
- Taking Metformin, vitamin D, or any hormonal therapy
About this study
Official title: The Effects of Vitamin D Supplementation on Transforming Growth Factor-beta1 and Vascular Endothelial Growth Factor in Vitamin D-Deficient Women With Polycystic Ovary Syndrome: A Randomized Placebo-Controlled Trial
Polycystic Ovary Syndrome (PCOS) affects 5 to 10% of women of reproductive age. It is characterized by a cluster of hyperandrogenism, hyperinsulinemia, menstrual dysfunction, hirsutism and infertility. Although the pathogenesis of PCOS is unknown, accumulating evidence suggests that the dysregulation of some angiogenic factors, such as transforming growth factor-β (TGF-β) and vascular endothelial growth factor (VEGF), may be implicated. TGF-βs and VEGF exert a diverse range of biological functions regulating cell proliferation, angiogenesis, fibroblast activation and tissue fibrosis. PCOS ovaries show all the hallmarks of TGF-β and VEGF upregulation, including increased collagen deposition in ovarian stroma and theca, supported by increased vascularity. Consistent with this, The investigators recently showed that TGF-β1 is increased in serum of PCOS women while its circulating receptor soluble endoglin (sENG) is decreased, resulting in greater TGF-β1 bioavailability. Furthermore, it has been shown that women with PCOS have increased VEGF levels in the serum and/or follicular fluid. PCOS patients also have decreased vitamin D levels, and vitamin D treatment has been previously shown to improve various clinical parameters in PCOS women, including glucose intolerance, hypertension and androgen levels. Interestingly, vitamin D has been shown to decrease TGF-β1 and VEGF levels in several diseases, including myelofibrosis and various human cancer cells. Therefore, the investigators hypothesize that vitamin D treatment of PCOS women will result in a decrease of serum TGF-β1 levels and/or VEGF levels concomitant with improvement in clinical disease parameters. In addition, the investigators hypothesize that improvement in clinical disease parameters will correlate with changes in serum VEGF levels and TGF-β1 bioavailability. Our aim in the present study is to investigate the effects of vitamin D treatment on serum VEGF and TGF-β1/sENG levels in PCOS women, and assess whether changes in these angiogenic factors following vitamin D treatment correlate with clinical disease in these women. For this end, PCOS patients who are vitamin D-deficient will be treated with vitamin D and their serum levels of VEGF, TGF-β1 and its sENG receptor will be measured before and after treatment. In addition, clinical disease parameters will be recorded before and 4 months after treatment, including serum glucose and insulin levels, serum androgen levels, and blood pressure.
The proposed study aims to identify a putative link between vitamin D, VEGF, and TGF-β1 in the context of PCOS, and provide a novel molecular explanation for the beneficial clinical effects of vitamin D on PCOS patients.
Read the detailed description
This study is a randomized, single blind, placebo-controlled trial to evaluate the effect of vitamin D on vitamin D-deficient women with PCOS. 93 reproductive-aged women diagnosed with PCOS presenting to Maimonides Medical Center for annual check-up between October 2013 and March 2015 were screened for vitamin D deficiency (defined as 25 hydroxy-vitaminD [25OH-D] levels <20 ng/mL). All participants signed the informed consent and the study was approved by the international review board (IRB) of Maimonides Medical Center. PCOS was diagnosed according to the Rotterdam Consensus (ESHRE/ASRM criteria), i.e. the presence of two of three criteria: oligo- or anovulation, signs of clinical hyperandrogenism, and/or biochemical signs of hyperandrogenism and polycystic ovaries on ultrasonography after exclusion of specific identifiable disorders (thyroid disorder, hyperprolactinemia, congenital adrenal hyperplasia, androgen-secreting tumors, and Cushing's syndrome). The investigators included women aged between 18 and 38 years who were not: 1) pregnant, postpartum, breastfeeding, or 2) taking any vitamin D supplements, metformin or any hormonal therapy.
Interventions and blood collection:
68 women diagnosed with PCOS and vitamin D deficiency were enrolled. Participants were allocated to each group according to a computer-generated list using ratio 2/1 (Vitamin D/placebo). Women allocated to vitamin D group received one capsule 50.000 IU of vitamin D3 once weekly for eight weeks. The vitamin D supplementation regimen was extracted from the Endocrine Society guidelines. Women in the placebo group received once capsule of placebo once weekly for eight weeks. The placebo was prepared at Maimonides Medical Center's pharmacy. To ensure compliance, The investigators called each participant once weekly and reminded her to take her pill. Fasting blood samples were collected by venipuncture before starting and within two weeks after completing the treatment (vitamin D or placebo). Blood samples were allowed to clot for 30 minutes at room temperature before centrifugation at 1,200 rpm for 10 minutes. Serum was stored at -80°C in aliquots until assayed.
The assays of all measured hormones, 25OH-D, VEGF, TGF-β1, sENG, and AMH:
Serum 25OH-D levels were measured before and after completing the treatment. The levels were determined by the ADVIA Centaur vitamin D assay (Siemens Healthcare Diagnostics). Dehydroepiandrosterone sulfate (DHEAS), testosterone, sex hormone-binding globulin (SHBG), thyroid-stimulating hormone (TSH), follicle-stimulating hormone (FSH), and luteinizing hormone (LH) were measured using IMMULITE 2000 XPi immunoassay system (Siemens Healthcare USA). Insulin and prolactin concentrations were quantified by DXL 800 immunoassay analyzer according to manufacturer's protocols (Beckman Coulter). Insulin resistance was calculated according to the homeostatic model assessment (HOMA) (29) by using the following formula: Insulin resistance (HOMA IR) = [fasting insulin (µU/mL) x fasting glucose (mmol/L)]/22.5. 17OH-progesterone level was determined by ELISA assay (Eagle BioSciences). AMH concentration was measured using the ultrasensitive AMH/MIS CLIA kit (AnshLabs). TGF-β1 concentration was measured using Human TGF-beta1 Quantikine ELISA kit according to manufacturer's protocols (R\&D Systems). sENG levels were quantified by Human Endoglin/CD105 Quantikine ELISA kit (R\&D Systems). VEGF concentration was quantified using Human VEGF Quantikine ELISA kit according to manufacturer's protocols (R\&D Systems). The inter-assay and intra-assay coefficients of variation for all assays were less than 10%.
Clinical parameters:
All the clinical parameters were evaluated before and four months after the completion of treatment. These parameters included blood pressure (BP), Ferriman-Gallwey score (FGS) (hirsutism score), acne status, and interval between periods.
Statistical analysis:
Data were tested for normality. All values were expressed as mean ± standard error of the mean (SEM). A paired student's t-test was used to compare pre- and post-treatment serum levels and clinical parameters. Correlation between changes in angiogenic factors and changes in clinical disease parameters was analyzed using Pearson's test and linear regression. X2-test was used to evaluate the changes in acne after treatment. SigmaStat (SPSS Science, Chicago, IL) was used for statistical analysis. P<0.05 was considered to be statistically significant.
- Conditions
- Polycystic Ovary Syndrome, Vitamin D Deficiency
- Being tested
- Vitamin D3, Placebo
- 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
Women allocated to vitamin D arm received one capsule 50.000 IU of vitamin D3 once weekly for eight weeks.
PlaceboOther
Women in the placebo arm received once capsule of placebo once weekly for eight weeks
| Study group | Role | What they receive |
|---|---|---|
| Vitamin D3 | Active comparator | Women allocated to vitamin D3 group received one capsule 50.000 IU of vitamin D3 once weekly for eight weeks. Receives: Drug: Vitamin D3 |
| Placebo | Placebo comparator | Women in the placebo group received once capsule of placebo once weekly for eight weeks. Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Effect of Vitamin D on Angiogenic Factors
Serum TGF-β1/sENG ratio as a measure of TGF-β1 bioavailability
Measured: Baseline (pre-treatment) and 8 weeks later (post-treatment)
Effect of Vitamin D on Angiogenic Factors
Serum VEGF level
Measured: Baseline (pre-treatment) and 8 weeks later (post-treatment)
Secondary outcomes (6)
The Effects of Vitamin D3 on Clinical Disease Parameters in Women With PCOS
Interval between periods as a measure ovulatory dysfunction
Measured: Baseline (pre-treatment) and 4 months later (two months after the completion of treatment)
The Effects of Vitamin D3 on Clinical Disease Parameters in Women With PCOS
Blood pressure
Measured: Baseline (pre-treatment) and 4 months later (two months after the completion of treatment)
The Effects of Vitamin D3 on Clinical Disease Parameters in Women With PCOS
The homeostatic model assessment (HOMA) is a method used to quantify insulin resistance. Insulin resistance is a condition in which cells fail to respond to the normal actions of the hormone insulin. The HOMA index was calculated as the product of fasting plasma blood glucose and insulin divided by 22.5.
Measured: Baseline (pre-treatment) and 8 weeks later (post-treatment)
The Effects of Vitamin D3 on Clinical Disease Parameters in Women With PCOS
Free testosterone
Measured: Baseline (pre-treatment) and 8 weeks later (post-treatment)
The Effects of Vitamin D3 on Clinical Disease Parameters in Women With PCOS
Lipid profile
Measured: Baseline (pre-treatment) and 8 weeks later (post-treatment)
The Effects of Vitamin D3 on Clinical Disease Parameters in Women With PCOS
Ferriman-Gallwey score is a method used to assess and quantify hirsutism in women. A total score < 8 is considered normal whereas a score of 8 to 15 indicates mild hirsutism. A score >15 indicates moderate or severe hirsutism.
Measured: Baseline (pre-treatment) and 4 months later (two months after the completion of treatment)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jun 2015 (estimated)
- Study startOct 2013
- Primary completionMar 2015
- Study completionMar 2015
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.
- 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
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 93 participants (actual)
Sponsor and investigators
- Lead sponsor
- Maimonides Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Richard Grazi, Maimonides Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02460380
- Sponsor's protocol ID
- 2013-06-03
- Status last verified
- Sep 2018
- First submitted
- 23 May 2015
- Last updated
- 12 Oct 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Irani M, Seifer DB, Grazi RV, Julka N, Bhatt D, Kalgi B, Irani S, Tal O, Lambert-Messerlian G, Tal R. Vitamin D Supplementation Decreases TGF-beta1 Bioavailability in PCOS: A Randomized Placebo-Controlled Trial. J Clin Endocrinol Metab. 2015 Nov;100(11):4307-14. doi: 10.1210/jc.2015-2580. Epub 2015 Oct 20.
PubMed 26485217
Study at a glance
From the registry record, last updated by the sponsor on 12 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Vitamin D Supplementation on Transforming Growth Factor-beta1 and Vascular Endothelial Growth Factor in Vitamin D-Deficient Women With Polycystic Ovary Syndrome: A Randomized Placebo-Controlled Trial
- ClinicalTrials.gov ID
- NCT02460380
- Acronym / sponsor ID
- 2013-06-03
- Conditions
- Polycystic Ovary Syndrome, Vitamin D Deficiency
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 93 participants (actual)
- Lead sponsor
- Maimonides Medical CenterUniversity, hospital or other
- Study start
- Oct 2013
- Primary completion
- Mar 2015 (actual)
- Study completion
- Mar 2015 (actual)
- First posted
- 2 Jun 2015 (estimated)
- Results
- Posted 14 Sep 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Polycystic Ovary Syndrome (PCOS) affects 5 to 10% of women of reproductive age. It is characterized by a cluster of hyperandrogenism, hyperinsulinemia, menstrual dysfunction, hirsutism and infertility. Although the pathogenesis of PCOS is unknown, accumulating evidence suggests that the dysregulation of some angiogenic factors, such as transforming growth factor-β (TGF-β) and vascular endothelial growth factor (VEGF), may be implicated. TGF-βs and VEGF exert a diverse range of biological functions regulating cell proliferation, angiogenesis, fibroblast activation and tissue fibrosis. PCOS ovaries show all the hallmarks of TGF-β and VEGF upregulation, including increased collagen deposition in ovarian stroma and theca, supported by increased vascularity. Consistent with this, The investigators recently showed that TGF-β1 is increased in serum of PCOS women while its circulating receptor soluble endoglin (sENG) is decreased, resulting in greater TGF-β1 bioavailability. Furthermore, it has been shown that women with PCOS have increased VEGF levels in the serum and/or follicular fluid. PCOS patients also have decreased vitamin D levels, and vitamin D treatment has been previously shown to improve various clinical parameters in PCOS women, including glucose intolerance, hypertension and androgen levels. Interestingly, vitamin D has been shown to decrease TGF-β1 and VEGF levels in several diseases, including myelofibrosis and various human cancer cells. Therefore, the investigators hypothesize that vitamin D treatment of PCOS women will result in a decrease of serum TGF-β1 levels and/or VEGF levels concomitant with improvement in clinical disease parameters. In addition, the investigators hypothesize that improvement in clinical disease parameters will correlate with changes in serum VEGF levels and TGF-β1 bioavailability. Our aim in the present study is to investigate the effects of vitamin D treatment on serum VEGF and TGF-β1/sENG levels in PCOS women, and assess whether changes in these angiogenic factors following vitamin D treatment correlate with clinical disease in these women. For this end, PCOS patients who are vitamin D-deficient will be treated with vitamin D and their serum levels of VEGF, TGF-β1 and its sENG receptor will be measured before and after treatment. In addition, clinical disease parameters will be recorded before and 4 months after treatment, including serum glucose and insulin levels, serum androgen levels, and blood pressure.
The proposed study aims to identify a putative link between vitamin D, VEGF, and TGF-β1 in the context of PCOS, and provide a novel molecular explanation for the beneficial clinical effects of vitamin D on PCOS patients.
Detailed description
This study is a randomized, single blind, placebo-controlled trial to evaluate the effect of vitamin D on vitamin D-deficient women with PCOS. 93 reproductive-aged women diagnosed with PCOS presenting to Maimonides Medical Center for annual check-up between October 2013 and March 2015 were screened for vitamin D deficiency (defined as 25 hydroxy-vitaminD [25OH-D] levels <20 ng/mL). All participants signed the informed consent and the study was approved by the international review board (IRB) of Maimonides Medical Center. PCOS was diagnosed according to the Rotterdam Consensus (ESHRE/ASRM criteria), i.e. the presence of two of three criteria: oligo- or anovulation, signs of clinical hyperandrogenism, and/or biochemical signs of hyperandrogenism and polycystic ovaries on ultrasonography after exclusion of specific identifiable disorders (thyroid disorder, hyperprolactinemia, congenital adrenal hyperplasia, androgen-secreting tumors, and Cushing's syndrome). The investigators included women aged between 18 and 38 years who were not: 1) pregnant, postpartum, breastfeeding, or 2) taking any vitamin D supplements, metformin or any hormonal therapy.
Interventions and blood collection:
68 women diagnosed with PCOS and vitamin D deficiency were enrolled. Participants were allocated to each group according to a computer-generated list using ratio 2/1 (Vitamin D/placebo). Women allocated to vitamin D group received one capsule 50.000 IU of vitamin D3 once weekly for eight weeks. The vitamin D supplementation regimen was extracted from the Endocrine Society guidelines. Women in the placebo group received once capsule of placebo once weekly for eight weeks. The placebo was prepared at Maimonides Medical Center's pharmacy. To ensure compliance, The investigators called each participant once weekly and reminded her to take her pill. Fasting blood samples were collected by venipuncture before starting and within two weeks after completing the treatment (vitamin D or placebo). Blood samples were allowed to clot for 30 minutes at room temperature before centrifugation at 1,200 rpm for 10 minutes. Serum was stored at -80°C in aliquots until assayed.
The assays of all measured hormones, 25OH-D, VEGF, TGF-β1, sENG, and AMH:
Serum 25OH-D levels were measured before and after completing the treatment. The levels were determined by the ADVIA Centaur vitamin D assay (Siemens Healthcare Diagnostics). Dehydroepiandrosterone sulfate (DHEAS), testosterone, sex hormone-binding globulin (SHBG), thyroid-stimulating hormone (TSH), follicle-stimulating hormone (FSH), and luteinizing hormone (LH) were measured using IMMULITE 2000 XPi immunoassay system (Siemens Healthcare USA). Insulin and prolactin concentrations were quantified by DXL 800 immunoassay analyzer according to manufacturer's protocols (Beckman Coulter). Insulin resistance was calculated according to the homeostatic model assessment (HOMA) (29) by using the following formula: Insulin resistance (HOMA IR) = [fasting insulin (µU/mL) x fasting glucose (mmol/L)]/22.5. 17OH-progesterone level was determined by ELISA assay (Eagle BioSciences). AMH concentration was measured using the ultrasensitive AMH/MIS CLIA kit (AnshLabs). TGF-β1 concentration was measured using Human TGF-beta1 Quantikine ELISA kit according to manufacturer's protocols (R\&D Systems). sENG levels were quantified by Human Endoglin/CD105 Quantikine ELISA kit (R\&D Systems). VEGF concentration was quantified using Human VEGF Quantikine ELISA kit according to manufacturer's protocols (R\&D Systems). The inter-assay and intra-assay coefficients of variation for all assays were less than 10%.
Clinical parameters:
All the clinical parameters were evaluated before and four months after the completion of treatment. These parameters included blood pressure (BP), Ferriman-Gallwey score (FGS) (hirsutism score), acne status, and interval between periods.
Statistical analysis:
Data were tested for normality. All values were expressed as mean ± standard error of the mean (SEM). A paired student's t-test was used to compare pre- and post-treatment serum levels and clinical parameters. Correlation between changes in angiogenic factors and changes in clinical disease parameters was analyzed using Pearson's test and linear regression. X2-test was used to evaluate the changes in acne after treatment. SigmaStat (SPSS Science, Chicago, IL) was used for statistical analysis. P<0.05 was considered to be statistically significant.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Vitamin D3 | Active comparator | Drug: Vitamin D3Women allocated to vitamin D3 group received one capsule 50.000 IU of vitamin D3 once weekly for eight weeks. |
| Placebo | Placebo comparator | Other: PlaceboWomen in the placebo group received once capsule of placebo once weekly for eight weeks. |
Who may qualify
- Ages
- 18 to 38 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Women with PCOS who have vitamin D deficiency (serum 25-hydroxyvitamin D<20 ng/mL)
Key exclusion criteria (2 listed)
- Pregnant, postpartum, breast feeding
- Taking Metformin, vitamin D, or any hormonal therapy
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 D3Women allocated to vitamin D arm received one capsule 50.000 IU of vitamin D3 once weekly for eight weeks. | Drug | Vitamin D3 |
| PlaceboWomen in the placebo arm received once capsule of placebo once weekly for eight weeks | Other | Placebo |
Primary outcome
Effect of Vitamin D on Angiogenic Factors
Time frame: Baseline (pre-treatment) and 8 weeks later (post-treatment)
Serum TGF-β1/sENG ratio as a measure of TGF-β1 bioavailability
Effect of Vitamin D on Angiogenic Factors
Time frame: Baseline (pre-treatment) and 8 weeks later (post-treatment)
Serum VEGF level
6 secondary outcomes
The Effects of Vitamin D3 on Clinical Disease Parameters in Women With PCOS
Time frame: Baseline (pre-treatment) and 4 months later (two months after the completion of treatment)
The Effects of Vitamin D3 on Clinical Disease Parameters in Women With PCOS
Time frame: Baseline (pre-treatment) and 4 months later (two months after the completion of treatment)
The Effects of Vitamin D3 on Clinical Disease Parameters in Women With PCOS
Time frame: Baseline (pre-treatment) and 8 weeks later (post-treatment)
The Effects of Vitamin D3 on Clinical Disease Parameters in Women With PCOS
Time frame: Baseline (pre-treatment) and 8 weeks later (post-treatment)
The Effects of Vitamin D3 on Clinical Disease Parameters in Women With PCOS
Time frame: Baseline (pre-treatment) and 8 weeks later (post-treatment)
The Effects of Vitamin D3 on Clinical Disease Parameters in Women With PCOS
Time frame: Baseline (pre-treatment) and 4 months later (two months after the completion of treatment)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Oct 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 26485217Irani M, Seifer DB, Grazi RV, Julka N, Bhatt D, Kalgi B, Irani S, Tal O, Lambert-Messerlian G, Tal R. Vitamin D Supplementation Decreases TGF-beta1 Bioavailability in PCOS: A Randomized Placebo-Controlled Trial. J Clin Endocrinol Metab. 2015 Nov;100(11):4307-14. doi: 10.1210/jc.2015-2580. Epub 2015 Oct 20.
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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.
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.
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 2 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 12 Oct 2018. Status can change between updates, so confirm with the study contact before making plans.
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?
Yes. Results are posted in the registry (first posted 14 Sep 2018). 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?
Effect of Vitamin D on Angiogenic Factors (time frame: Baseline (pre-treatment) and 8 weeks later (post-treatment)). 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?
On the ClinicalTrials.gov record for NCT02460380, 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 12 Oct 2018.