A Phase 2 interventional study of Vitamin D3 and Placebo Oral Tablet in PCOS and Vitamin D, sponsored by Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh. Completed at 1 site in Bangladesh. Open to female participants aged 18 Years to 45 Years. Per ClinicalTrials.gov, last updated 2024-08-12.
Sponsored by Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh · Phase 2, Interventional, and Treatment
The goal of this randomized, double blind, placebo-controlled clinical trial is to learn about, the effect of low dose vitamin D supplementation compares with placebo-controlled group on testosterone level in women with polycystic ovary syndrome. Half of Participants will receive vitamin D and metformin while other half placebo and metformin.
PCOS poses a significant challenge to women's health and quality of life. PCOS is a common heterogenous endocrine disorder in reproductive-aged women. PCOS is characterized by the presence of polycystic ovaries, menstrual dysfunction, infertility and biochemical (elevated androgens) and clinical (hirsutism and/or acne) hyperandrogenism. Hyperandrogenism and insulin resistance exacerbate one another in the development of PCOS, Research has suggested a potential link between Vitamin D deficiency and the prevalence and severity of PCOS. There is also evidence that Vitamin D has a direct effect on the ovaries and adrenal glands, which are the primary sites of androgen production in women. Vitamin D has been found to inhibit the synthesis of androgens in these glands, suggesting that it could potentially be used to manage hyperandrogenism in women with PCOS. Furthermore, studies have shown that Vitamin D supplementation can reduce insulin resistance in women with PCOS, which can subsequently lead to a decrease in the overproduction of androgens. may improves menstrual irregularities.
In human ovarian tissue, vitamin D stimulation of oestrogen and progesterone production and lack of effect on testosterone production may be explained by the expression of the aromatase gene and augmentation of aromatase activity by vitamin D.
Serum 25OH-D level has been shown to be negatively correlated with serum androgen levels DHEAS, testosterone and hirsutism. Assumption that vitamin D supplementation may also have a positive impact on serum testosterone levels. Metformin is prescribed for reducing IR in PCOS women. This is a double-blind, randomized placebo-controlled trial in PCOS women who are receiving Metformin therapy. The intervention group will receive Vitamin D Cholecalciferol (D3) 1000 I.U daily for 8 weeks, with the Metformin as prescribed by the physician whereas control group will receive placebo with Metformin during the study period. We will compare change of Total Testosterone, Vitamin D level, Fasting blood glucose, Hirsutism, Menstrual regularities and BMI, at the time of recruitment with after 8 weeks intervention in both the intervention and placebo controlled groups.
975 studies on the registry are indexed under Polycystic Ovary Syndrome; 177 are open to participants now.
This study's enrollment of 66 is close to the median of 70 across 710 interventional studies indexed under Polycystic Ovary Syndrome.
Browse Polycystic Ovary Syndrome studies →Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh is the lead sponsor of 127 studies on the registry; 24 are open to participants now.
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Age 18 years to 45 years
Exclusion Criteria:
Diagnosed case of diabetes mellitus, liver disease, heart disease, kidney stones and disease, Tuberculosis, hyperparathyroidism
Patients receiving vitamin D, calcium supplementation within the last two months
Known hypersensitivity to Vitamin D
Patients unwilling to participate or unwilling to give written consent
Drug: Vitamin D3
Drug: Placebo Oral Tablet
These patients will receive Vitamin D3 1000 I.U daily and the Metformin as prescribed by the physician for 8 weeks.
These patients will receive placebo and the Metformin as prescribed by the physician for the same periods of study group
Total Testosterone
The estimated testosterone level, is 15-46 ng/dL for a reproductive aged normal menstrual cycles woman . The results demonstrate that there is a diurnal rhythm of testosterone secretion during in girls, with the highest levels in the morning 6 am-10 am .Biochemical hyperandrogenism (TT \>46 ng/dl)
Time frame: 1 year
Fasting blood glucose
Impaired fasting glucose (IFG) when FBG is between 5.6-6.9 mmol/L
Time frame: 1 year
Menstrual regularity
* Polymenorrheic (\<21 days), * Eumenorrheic (21 - 35 days), * Oligomenorrheic (36 days - 3 months) and * Amenorrheic (\>3 months)
Time frame: 1 year
Hirsutism
mFG score of ≥6
Time frame: 1 year
Vitamin D
A blood level of less than 20 ng/ml is considered deficiency, insufficiency is 21- 29 ng/ml, and sufficiency is 30 ng/ml or higher.
Time frame: 1 Year
BMI
Status BMI Underweight 15-19.9 Normal weight 20-24.9 Overweight 25-29.9 Class I Obesity 30-34.9 Class II Obesity 35-39.9 Class III Obesity ≥ 40
Time frame: 1 Year
Plan to share: Yes
No publications or documents are linked to this record.
Ran from Sep 2023 to primary completion in Apr 2024, 7 months.
Of 21 phase 2 interventional studies under Polycystic Ovary Syndrome, half reached primary completion within 17 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 29. This study's 7 months is below that.
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This study is completed, as verified in Aug 2024. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Cholecalciferol
Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh →