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出境医 / 临床实验 / Vitamin D and Polycystic Ovarian Syndrome
Vitamin D and Polycystic Ovarian Syndrome
Study Description
Brief Summary:
Primary Objectives:
To evaluate the efficacy of metformin and Vitamin D supplementation on serum insulin and serum androgen levels (Total testosterone, Steroid Hormone Binding Globulin, Free Androgen Index) levels compared metformin alone in infertile Poly cystic ovarian females of reproductive age group.
Secondary Objectives:
To measure change in endometrial thickness/number of follicles and follicular size by day 12 trans-vaginal ultrasound in the intervention group i.e. combination of metformin and vitamin D supplementation
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Infertility, Female Infertility Vitamin D Deficiency | Drug: Vitamin D | Phase 2 |
Detailed Description:
Polycystic ovary syndrome (PCOS) as defined by "the presence of any two out of three criteria i.e. Oligo and/or anovulation, excess androgen activity and/or polycystic ovarian morphology on ultrasound", is a prevalent cause of female infertility. In the endocrine milieu of PCOS higher levels of insulin due to insulin resistance (IR) exert direct effects on the ovaries, release insulin-like growth factor 1 (IGF-1) from the liver and both then increase levels of testosterone. The resultant prevents the growth of ovarian follicles to acquire the required dimension for ovulation (i.e. > 10 mm) hence leading to anovulation and therefore subfertility. Vitamin D (VD) has found to be predominantly deficient in PCOS females, documented to cause IR giving rise to anovulatory cycles, hyperandrogenism and other significant features of PCOS. Therefore, we have hypothesized that treatment with VD in PCOS females can reduce IR, improve ovulation and signs of hyperandrogenism. Since Metformin is frequently prescribed for reducing IR and hence the treatment for anovulatory infertility in these females, we have planned to conduct an open label randomized control trial in PCOS infertile females who have vitamin D levels < than 25 ng/ml and are receiving Metformin therapy after ethical approval from Aga Khan University. The intervention group will receive VD Cholecalciferol (D2) 50,000 I.U once weekly for 12 weeks, followed by 50,000 I.U once every fortnight for 24 weeks with the Metformin treatment as prescribed by the physician whereas control group will receive Metformin treatment during the study period. We will compare change in number of dominant follicles (more than 10 mm) / endometrial thickness in both groups by Day 12 trans-vaginal ultrasound at the time of enrollment with scans done after 12 and 24 weeks. The other biochemical parameters [Total Testosterone, Steroid Hormone Binding Globulin, Free Androgen Index, Lipid accumulation product LAP , serum Insulin, C Reactive Protein (hs-CRP) Serum Triglycerides, serum calcium and albumin] will be done at the time of recruitment in both the intervention and control groups and compared
Study Design
| Study Type : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 300 participants |
| Allocation: | Randomized |
| Intervention Model: | Single Group Assignment |
| Intervention Model Description: | Infertile females with Polycystic Ovarian Syndrome |
| Masking: | None (Open Label) |
| Primary Purpose: | Treatment |
| Official Title: | Efficacy of Vitamin D Supplementation and Metformin Compared to Metformin Alone for Improvement in Follicle Size of Infertile Females With Polycystic Ovary Syndrome: a Randomized Open Label Trial |
| Estimated Study Start Date : | January 1, 2020 |
| Estimated Primary Completion Date : | December 31, 2021 |
| Estimated Study Completion Date : | June 13, 2022 |
Arms and Interventions
| Arm | Intervention/treatment |
|---|---|
|
Experimental: Vitamin D supplement
he intervention group will receive VD Cholecalciferol (D2) 50,000 I.U once weekly for 12 weeks, followed by 50,000 I.U once every fortnight for 24 weeks with the Metformin treatment as prescribed by the physician whereas
|
Drug: Vitamin D
Vitamin D supplementation
|
|
No Intervention: Control
control group will receive Metformin treatment during the study period.
|
Outcome Measures
Primary Outcome Measures :
- • Insulin levels [ Time Frame: 24 weeks ]Decrease in insulin levels 60%
- • serum androgen levels [ Time Frame: 24 weeks ]Decrease in Serum Androgen levels
Secondary Outcome Measures :
- Endometrial thickness [ Time Frame: 24 weeks ]increase in endometrial thickness to 2mm
- Lipid Accumulation Product [ Time Frame: 24 weeks ]reduction in LAP
Eligibility Criteria
| Ages Eligible for Study: | 18 Years to 36 Years (Adult) |
| Sexes Eligible for Study: | All |
| Gender Based Eligibility: | Yes |
| Accepts Healthy Volunteers: | Yes |
Criteria
Inclusion Criteria:
- Females with age range 18- 36 years, from all ethnic background having primary infertility with diagnosis of PCOS when at least 2 of these 3 elements are present: hyperandrogenism, chronic anovulation and polycystic ovaries and Vitamin D deficiency serum levels < 25 nmol/L
Exclusion Criteria:
exclusion criteria at baseline will be excluded from the study
- Females with secondary Infertility
- Hypercalcemia (plasma calcium concentrations> 2.65 mmol/L)
- Exclude women with Tuberculosis or other granulomatous disorders.
- Women receiving vitamin D replacement, oral contraceptives, hormonal replacement therapy, glucocorticoids, calcium supplementation, insulin-sensitizing drugs(incretin mimetic drugs, thiazolidinedione, sulfonylurea), lipid-lowering drugs or other drugs affecting insulin sensitivity or serum androgens (e.g., niacin, corticosteroids, beta-blockers, calcium channel blockers, thiazide diuretics), anti-epileptics, anti-retroviral, cholestyramine, anti-fungal, statins, H2 blockers, immunosuppressants, chemotherapeutic agents, antimicrobials (Rifampicin, isoniazid, hydroqychloroquin) or any other drug modifying lipid metabolism in the previous 3 months prior to study
- Women with congenital adrenal hyperplasia, Cushing's syndrome, androgen-secreting tumors, type 2 diabetes mellitus, renal, hepatic or thyroid disorders, hyperparathyroidism, malabsorption syndromes, Chronic Kidney Disease Hepatic failure, cystic fibrosis, vaginal bleeding of unknown etiology Women Those who had Bariatric surgery will also be excluded.
Contacts and Locations
Contacts
| Contact: Rehana K Rehman, PhD | 00922134864460 ext 4460 | drrehana7@gmail.com |
Locations
| Pakistan | |
| Aga Khan University | |
| Karachi, Pakistan | |
Sponsors and Collaborators
Aga Khan University
| Tracking Information | |||||||
|---|---|---|---|---|---|---|---|
| First Submitted Date ICMJE | June 13, 2019 | ||||||
| First Posted Date ICMJE | June 18, 2019 | ||||||
| Last Update Posted Date | June 18, 2019 | ||||||
| Estimated Study Start Date ICMJE | January 1, 2020 | ||||||
| Estimated Primary Completion Date | December 31, 2021 (Final data collection date for primary outcome measure) | ||||||
| Current Primary Outcome Measures ICMJE |
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| Original Primary Outcome Measures ICMJE | Same as current | ||||||
| Change History | No Changes Posted | ||||||
| Current Secondary Outcome Measures ICMJE |
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| Original Secondary Outcome Measures ICMJE | Same as current | ||||||
| Current Other Pre-specified Outcome Measures | Not Provided | ||||||
| Original Other Pre-specified Outcome Measures | Not Provided | ||||||
| Descriptive Information | |||||||
| Brief Title ICMJE | Vitamin D and Polycystic Ovarian Syndrome | ||||||
| Official Title ICMJE | Efficacy of Vitamin D Supplementation and Metformin Compared to Metformin Alone for Improvement in Follicle Size of Infertile Females With Polycystic Ovary Syndrome: a Randomized Open Label Trial | ||||||
| Brief Summary |
Primary Objectives: To evaluate the efficacy of metformin and Vitamin D supplementation on serum insulin and serum androgen levels (Total testosterone, Steroid Hormone Binding Globulin, Free Androgen Index) levels compared metformin alone in infertile Poly cystic ovarian females of reproductive age group. Secondary Objectives: To measure change in endometrial thickness/number of follicles and follicular size by day 12 trans-vaginal ultrasound in the intervention group i.e. combination of metformin and vitamin D supplementation |
||||||
| Detailed Description | Polycystic ovary syndrome (PCOS) as defined by "the presence of any two out of three criteria i.e. Oligo and/or anovulation, excess androgen activity and/or polycystic ovarian morphology on ultrasound", is a prevalent cause of female infertility. In the endocrine milieu of PCOS higher levels of insulin due to insulin resistance (IR) exert direct effects on the ovaries, release insulin-like growth factor 1 (IGF-1) from the liver and both then increase levels of testosterone. The resultant prevents the growth of ovarian follicles to acquire the required dimension for ovulation (i.e. > 10 mm) hence leading to anovulation and therefore subfertility. Vitamin D (VD) has found to be predominantly deficient in PCOS females, documented to cause IR giving rise to anovulatory cycles, hyperandrogenism and other significant features of PCOS. Therefore, we have hypothesized that treatment with VD in PCOS females can reduce IR, improve ovulation and signs of hyperandrogenism. Since Metformin is frequently prescribed for reducing IR and hence the treatment for anovulatory infertility in these females, we have planned to conduct an open label randomized control trial in PCOS infertile females who have vitamin D levels < than 25 ng/ml and are receiving Metformin therapy after ethical approval from Aga Khan University. The intervention group will receive VD Cholecalciferol (D2) 50,000 I.U once weekly for 12 weeks, followed by 50,000 I.U once every fortnight for 24 weeks with the Metformin treatment as prescribed by the physician whereas control group will receive Metformin treatment during the study period. We will compare change in number of dominant follicles (more than 10 mm) / endometrial thickness in both groups by Day 12 trans-vaginal ultrasound at the time of enrollment with scans done after 12 and 24 weeks. The other biochemical parameters [Total Testosterone, Steroid Hormone Binding Globulin, Free Androgen Index, Lipid accumulation product LAP , serum Insulin, C Reactive Protein (hs-CRP) Serum Triglycerides, serum calcium and albumin] will be done at the time of recruitment in both the intervention and control groups and compared | ||||||
| Study Type ICMJE | Interventional | ||||||
| Study Phase ICMJE | Phase 2 | ||||||
| Study Design ICMJE | Allocation: Randomized Intervention Model: Single Group Assignment Intervention Model Description: Infertile females with Polycystic Ovarian Syndrome Masking: None (Open Label)Primary Purpose: Treatment |
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| Condition ICMJE |
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| Intervention ICMJE | Drug: Vitamin D
Vitamin D supplementation
|
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| Study Arms ICMJE |
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| Publications * | Not Provided | ||||||
|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||||
| Recruitment Status ICMJE | Not yet recruiting | ||||||
| Estimated Enrollment ICMJE |
300 | ||||||
| Original Estimated Enrollment ICMJE | Same as current | ||||||
| Estimated Study Completion Date ICMJE | June 13, 2022 | ||||||
| Estimated Primary Completion Date | December 31, 2021 (Final data collection date for primary outcome measure) | ||||||
| Eligibility Criteria ICMJE |
Inclusion Criteria:
Exclusion Criteria: exclusion criteria at baseline will be excluded from the study
|
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| Sex/Gender ICMJE |
|
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| Ages ICMJE | 18 Years to 36 Years (Adult) | ||||||
| Accepts Healthy Volunteers ICMJE | Yes | ||||||
| Contacts ICMJE |
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| Listed Location Countries ICMJE | Pakistan | ||||||
| Removed Location Countries | |||||||
| Administrative Information | |||||||
| NCT Number ICMJE | NCT03989778 | ||||||
| Other Study ID Numbers ICMJE | 124 | ||||||
| Has Data Monitoring Committee | Yes | ||||||
| U.S. FDA-regulated Product |
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| IPD Sharing Statement ICMJE |
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| Responsible Party | Rehana Rehman, Aga Khan University | ||||||
| Study Sponsor ICMJE | Aga Khan University | ||||||
| Collaborators ICMJE | Not Provided | ||||||
| Investigators ICMJE | Not Provided | ||||||
| PRS Account | Aga Khan University | ||||||
| Verification Date | June 2019 | ||||||
|
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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