Vitamin D and Polycystic Ovarian Syndrome
关键词
抽象
描述
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
日期
| 最后验证: | 05/31/2019 |
| 首次提交: | 06/12/2019 |
| 提交的预估入学人数: | 06/16/2019 |
| 首次发布: | 06/17/2019 |
| 上次提交的更新: | 06/16/2019 |
| 最近更新发布: | 06/17/2019 |
| 实际学习开始日期: | 12/31/2019 |
| 预计主要完成日期: | 12/30/2021 |
| 预计完成日期: | 06/12/2022 |
状况或疾病
干预/治疗
Drug: Vitamin D supplement
相
手臂组
| 臂 | 干预/治疗 |
|---|---|
| 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 supplement Vitamin D supplementation |
| No Intervention: Control control group will receive Metformin treatment during the study period. |
资格标准
| 有资格学习的年龄 | 18 Years 至 18 Years |
| 有资格学习的性别 | All |
| 接受健康志愿者 | 是 |
| 标准 | 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. |
结果
主要结果指标
1. • Insulin levels [24 weeks]
2. • serum androgen levels [24 weeks]
次要成果指标
1. Endometrial thickness [24 weeks]
2. Lipid Accumulation Product [24 weeks]
