Efficacy of Injectable Vitamin D Supplementation in Females With Polycystic Ovary Syndrome
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ClinicalTrials.gov Identifier: NCT06045351 |
Recruitment Status :
Recruiting
First Posted : September 21, 2023
Last Update Posted : September 28, 2023
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Anovulatory Infertility | Drug: Vitamin D Other: Active Comparator | Phase 1 |
This study will comprise of two groups (A and B) with 71 participants in each group carried for a duration of 24 weeks.
Intervention Details for Group A (Duration 1-12 weeks):
Participants will be given Vitamin D (VD) supplementation at a dose of 600,000 IU along with Calcium 1000 mg/day.
Mid-Point (At 12 weeks):
Patients will have a consultation for clinical interpretation. They will undergo biochemical assessment, including the estimation of Insulin Resistance, Free Androgen Index, and Total Antioxidant Capacity.
After 12 weeks They will receive standard treatment for Polycystic Ovary Syndrome (PCOS), which includes Glucophage XR 750 mg once at dinner for 15 days, then twice daily. Capsule Progeffik 100 mg once at night every 3 weeks, then 1 week off and Calcium 1000 mg/day
Intervention Details for Group B (Duration 1-12 weeks):
Participants in Group B will receive standard PCOS treatment mentioned earlier:
Glucophage XR 750 mg once at dinner for 15 days, then twice daily. Capsule Progeffik 100 mg once at night every 3 weeks, then 1 week off. Additionally, they receive Calcium 1000 mg/day.
Mid-Point (At 12 weeks):
Patients will have a consultation for clinical interpretation. They will undergo biochemical assessment, including the estimation of Insulin Resistance, Free Androgen Index, and Total Antioxidant Capacity.
Intervention Details for Group A (After 12 weeks)
They will receive VD supplementation (600,000 IU) during this time and continue to receive Calcium 1000 mg/day.
Calculations of HOMA-IR and Free Androgen Index will be done at 12 and 24 weeks and the results will be compared.
{HOMA-IR: HOMA- IR index, a commonly used marker of IR, will be calculated using the formula: HOMA-IR = fasting glucose levels [mmol/L] × fasting insulin levels [μU/mL]/22.5 Free Androgen Index will be derived from TT and SHBG, normally measured in nanomoles per liter. FAI =100 (TT /SHBG)}
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 142 participants |
Allocation: | Randomized |
Intervention Model: | Crossover Assignment |
Intervention Model Description: | Infertile females with Polycystic Ovarian Syndrome |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | Efficacy of Vitamin D Supplementation in Females With Polycystic Ovary Syndrome: a Randomized Open Label Delayed-start Design |
Estimated Study Start Date : | January 1, 2024 |
Estimated Primary Completion Date : | December 31, 2024 |
Estimated Study Completion Date : | December 31, 2025 |
Arm | Intervention/treatment |
---|---|
Experimental: VD supplementation
Experimental Group (Group A; n=71): The intervention (experimental) group will receive VD injections 600,000 I.U I/M once with 1 gram calcium supplemental daily in the initial 12 weeks. After that standard PCOS care; i) Glucophage XR 750 mg (once for 15 days then twice daily) ii) progesterone supplementation (1 capsule Progeffik 100 mg every 3 weeks, then 1 week off) and iii) calcium supplements will be given for next 12 weeks. |
Drug: Vitamin D
Intervention Group Initial 12 weeks;
Other Names:
|
Active Comparator: Control
Control Group (Group B; n=71): Participants will receive standard PCOS treatment; Glucophage XR 750 mg once at dinner for 15 days then twice daily and Capsule Progeffik 100 mg once at night every 3 weeks, then 1 week off for initial-- 12 weeks. Then VD supplementation (600,000 IUI/M) will be given once during the study period with Calcium 1000 mg/day and continued Standard PCOS treatment from 12- 24 weeks |
Other: Active Comparator
Active Comparator (Group B; n=71): Initial-- 12 weeks;
Other Name: Group B |
- hyperandrogenism [ Time Frame: 24 weeks ]hyperandrogenism by Free Androgen Index [Total Testosterone, Steroid Hormone Binding Globulin
- insulin Resistance [ Time Frame: 24 weeks ]HOMA-IR (serum Insulin, Fasting Blood Glucose)
- oxidative stress [ Time Frame: 24 weeks ]Total Antioxidant Capacity
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Ages Eligible for Study: | 18 Years to 45 Years (Adult) |
Sexes Eligible for Study: | Female |
Gender Based Eligibility: | Yes |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
- Recently diagnosed PCOS with presence of at least 2 of these 3 elements: clinical or biochemical signs of hyperandrogenism, chronic anovulation and polycystic ovaries (1) (from reports of available routine TVS), with VDD serum levels VD <20 ng/ml(10), age range 18- 45 years, from all ethnic background will be included.
Exclusion Criteria:
-
: Exclusion of subjects will be done by the Co-Principal Investigators (Co-PI) after history, examination and complete evaluation in the respective clinics. All female subjects meeting any of the following criteria will be excluded from the study
- Pregnancy
- Hypercalcemia (plasma calcium concentrations> 2.65 mmol/L)
- Tuberculosis or other granulomatous disorders
- Chronic liver disease or alanine transaminase (ALT) level 3 times higher than the normal limit, chronic
- Kidney disease or serum creatinine >2.0 mg/dL,
- Drug Therapies: VD replacement ; participants who had received VD injection in the last 3 months prior to recruitment in the study, 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, immunosuppressant, chemotherapeutic agents, antimicrobials (Rifampicin, Isoniazid, Hydroxychloroquine) or any other drug modifying lipid metabolism in the previous 3 months prior to study
- Suffering from 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 or /and suffering from COVID-19 (within 3 months).
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT06045351
Contact: Rehana Rehman, PhD | 00922134864460 ext 4460 | drrehana7@gmail.com |
Pakistan | |
Aga Khan University Hospital | Recruiting |
Karachi, Sindh, Pakistan, 75500 | |
Contact: Rehana Rehman, PhD 03072227775 rehana.rehman@aku.edu |
Principal Investigator: | Rehana Rehman, PhD | Aga Khan University |
Responsible Party: | Rehana Rehman, Professor, Aga Khan University |
ClinicalTrials.gov Identifier: | NCT06045351 |
Other Study ID Numbers: |
AKUBBS |
First Posted: | September 21, 2023 Key Record Dates |
Last Update Posted: | September 28, 2023 |
Last Verified: | September 2023 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
Product Manufactured in and Exported from the U.S.: | No |
Poly cystic Ovarian Syndrome randomized open label trial; delayed-start design vitamin D Pakistan |
Polycystic Ovary Syndrome Infertility Genital Diseases Urogenital Diseases Ovarian Cysts Cysts Neoplasms Ovarian Diseases Adnexal Diseases Genital Diseases, Female |
Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Gonadal Disorders Endocrine System Diseases Vitamin D Vitamins Micronutrients Physiological Effects of Drugs Bone Density Conservation Agents |