PCOSPhase 2NCT06101147
Effect of Vitamin D Supplementation on Testosterone Level in Women With Polycystic Ovary Syndrome
A Phase 2 study testing Vitamin D3 in people with PCOS and Vitamin D, run by Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh at 1 site in Bangladesh.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- What is being tested?
- Vitamin D3
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 66 participants
- Where
- 1 siteBangladesh
- Study dates
- 21 Sep 2023to 30 Jul 2024
- Phase
- Phase 2
- Are there results?
- None posted in the registry
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 45 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Diagnosed case of PCOS
- Age 18 years to 45 years
Who cannot join
- Pregnancy, lactating women
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Vitamin D Supplementation on Testosterone Level in Women With Polycystic Ovary Syndrome: A Randomized, Double-blind, Placebo-controlled Trial
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.
Read the detailed description
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.
- Being tested
- Vitamin D3, Placebo Oral Tablet
- Keywords
- PCOS, Vitamin D, Testosterone
- Medical subject headings
- Polycystic Ovary Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vitamin D3Drug
These patients will receive Vitamin D3 1000 I.U daily and the Metformin as prescribed by the physician for 8 weeks.
Placebo Oral TabletDrug
These patients will receive placebo and the Metformin as prescribed by the physician for the same periods of study group
| Study group | Role | What they receive |
|---|---|---|
| Vitamin D group | Experimental | Not described Receives: Drug: Vitamin D3 |
| Placebo group | Placebo comparator | Not described Receives: Drug: Placebo Oral Tablet |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 1 year
Secondary outcomes (5)
Fasting blood glucose
Impaired fasting glucose (IFG) when FBG is between 5.6-6.9 mmol/L
Measured: 1 year
Menstrual regularity
- Polymenorrheic (<21 days),
- Eumenorrheic (21 - 35 days),
- Oligomenorrheic (36 days - 3 months) and
- Amenorrheic (>3 months)
Measured: 1 year
Hirsutism
mFG score of ≥6
Measured: 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.
Measured: 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
Measured: 1 Year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Oct 2023
- Study start21 Sep 2023
- Primary completion30 Apr 2024
- Study completion30 Jul 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PCOSStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 66 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nilufar Yasmin, Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh
- Investigators
- Nilufar Yasmin, MD, Principal investigator, Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06101147
- Sponsor's protocol ID
- BSMMU/2023/11021
- Status last verified
- Aug 2024
- First submitted
- 20 Oct 2023
- Last updated
- 12 Aug 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 12 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Vitamin D Supplementation on Testosterone Level in Women With Polycystic Ovary Syndrome: A Randomized, Double-blind, Placebo-controlled Trial
- ClinicalTrials.gov ID
- NCT06101147
- Acronym / sponsor ID
- BSMMU/2023/11021
- Keywords
- PCOS, Vitamin D, Testosterone
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 66 participants (actual)
- Lead sponsor
- Bangabandhu Sheikh Mujib Medical University, Dhaka, BangladeshUniversity, hospital or other
- Study start
- 21 Sep 2023 (actual)
- Primary completion
- 30 Apr 2024 (actual)
- Study completion
- 30 Jul 2024 (actual)
- First posted
- 26 Oct 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Vitamin D group | Experimental | Drug: Vitamin D3 |
| Placebo group | Placebo comparator | Drug: Placebo Oral Tablet |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Diagnosed case of PCOS
- Age 18 years to 45 years
Key exclusion criteria (5 listed)
- Pregnancy, lactating women
- 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
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 D3These patients will receive Vitamin D3 1000 I.U daily and the Metformin as prescribed by the physician for 8 weeks. | Drug | Vitamin D group |
| Placebo Oral TabletThese patients will receive placebo and the Metformin as prescribed by the physician for the same periods of study group | Drug | Placebo group |
Primary outcome
Total Testosterone
Time frame: 1 year
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)
5 secondary outcomes
Fasting blood glucose
Time frame: 1 year
Menstrual regularity
Time frame: 1 year
Hirsutism
Time frame: 1 year
Vitamin D
Time frame: 1 Year
BMI
Time frame: 1 Year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Aug 2024.
- Individual participant dataSharing planned: Yes
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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.
Nilufar Yasmin, MD principal investigator
Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Vitamin D3 in people with PCOS and Vitamin D, run by Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh at 1 site in Bangladesh.
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 2 inclusion and 5 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 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Bangladesh. Whether a site is taking part right now should be confirmed with that site. See every site.
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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Total Testosterone (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 Aug 2024.