Polyendocrine Metabolic Ovarian Syndrome (PMOS)NCT07801001
Effect of Zinc Supplementation on Insulin Resistance and Clinical Features in Women With Polyendocrine Metabolic Ovarian Syndrome.
A study testing Tab. Elemental Zinc 50 mg and Elemental Zinc 50mg in people with Polyendocrine Metabolic Ovarian Syndrome (PMOS), run by Bangladesh Medical University at 1 site in Bangladesh.
Trial summary
Polyendocrine Metabolic Ovarian Syndrome (PMOS) is the most common endocrinopathy in women of reproductive age, and is mechanistically anchored in insulin resistance (IR), and drives the downstream cascade of hyperandrogenism, anovulation, dyslipidaemia and long-term type 2 diabetes risk. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Polyendocrine Metabolic Ovarian Syndrome (PMOS)
- What is being tested?
- Tab. Elemental Zinc 50 mg and Elemental Zinc 50mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 74 participants
- Where
- 1 siteBangladesh
- Study dates
- Feb 2027to Jul 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- the updated evidence based Rotterdam Criteria (revised 2023)
- newly diagnosed women with PMOS
- age above 18 years upto 45 years
Who cannot join
- Pregnancy and lactating mother.
- diagnosed case of Diabetes mellitus, liver disease, kidney disease, cardiovascular disease
- Any acute or chronic infective or inflammatory disease.
- Patients receiving Zinc supplementation within the last three months.
- Exclusion of PMOS mimicking disease include hyperprolactinemia, adrenal hyperandrogenism, ovarian hyperandrogenism, cushing syndrome, acromegaly etc.
- Known allergy to Zinc supplementation.
- Those who will not give informed consent
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Effect of Zinc Supplementation on Insulin Resistance and Clinical Features in Women With Polyendocrine Metabolic Ovarian Syndrome: A Randomized, Double Blind Placebo-Controlled Trial.
Polyendocrine Metabolic Ovarian Syndrome (PMOS) is the most common endocrinopathy in women of reproductive age, and is mechanistically anchored in insulin resistance (IR), and drives the downstream cascade of hyperandrogenism, anovulation, dyslipidaemia and long-term type 2 diabetes risk. South Asian women -including Bangladeshi women - develop IR at lower BMI thresholds than other populations and simultaneously carry one of the world's highest burdens of zinc deficiency (57% of non-pregnant non-lactating women). Zinc is structurally required for pancreatic β-cell insulin synthesis, modulates insulin-receptor signaling and PI3K/Akt-mediated glucose uptake, and acts as a cofactor for Cu/Zn-superoxide dismutase, suppressing the oxidative stress and NF-κB-driven inflammation that perpetuate IR in PMOS. Despite this strong mechanistic rationale, no randomised trial of zinc supplementation in PMOS has been conducted in any South Asian population.
To evaluate the effect of 12 weeks of oral zinc supplementation, as adjunct to standard conventional therapy, on insulin resistance (HOMA-IR) and on clinical and biochemical features of PMOS in Bangladeshi women.
Read more
A randomised, double-blind, placebo-controlled trial will be conducted at the Department of Pharmacology in collaboration with the Department of Obstetrics \& Gynaecology, Bangladesh Medical University (BMU), Dhaka. Seventy four newly diagnosed women with PMOS (Rotterdam / 2023 ESHRE criteria), aged 18-45 years, will be randomised 1:1 to receive elemental zinc 50 mg/day or an identical-appearing placebo, in addition to standard conventional therapy, for 12 weeks. The primary outcome is change in HOMA-IR from baseline to 12 weeks. Secondary outcomes include change in serum zinc, serum triglycderide, biomarker of oxidative stress (serum malondialdehyde), modified Ferriman-Gallwey (mFG) hirsutism score, BMI, and menstrual regularity. Between-arm comparisons will use unpaired t-tests / Mann-Whitney U; within-arm changes by paired t-tests; categorical outcomes by χ²; and the relationship between change in serum zinc and changes in HOMA-IR, mFG and androgen markers by Pearson / Spearman correlation.
In conclusion, combining zinc supplementation with the conventional treatment might be potentially have a safe, low cost, substantial impact on insulin resistance, lipid profile, oxidative stress and hormonal measures in patients with PMOS.
Read the detailed description
Polyendocrine Metabolic Ovarian Syndrome (PMOS) is the most common endocrinopathy in women of reproductive age, and is mechanistically anchored in insulin resistance (IR), and drives the downstream cascade of hyperandrogenism, anovulation, dyslipidaemia and long-term type 2 diabetes risk. South Asian women -including Bangladeshi women - develop IR at lower BMI thresholds than other populations and simultaneously carry one of the world's highest burdens of zinc deficiency (57% of non-pregnant non-lactating women). Zinc is structurally required for pancreatic β-cell insulin synthesis, modulates insulin-receptor signaling and PI3K/Akt-mediated glucose uptake, and acts as a cofactor for Cu/Zn-superoxide dismutase, suppressing the oxidative stress and NF-κB-driven inflammation that perpetuate IR in PMOS. Despite this strong mechanistic rationale, no randomised trial of zinc supplementation in PMOS has been conducted in any South Asian population.
To evaluate the effect of 12 weeks of oral zinc supplementation, as adjunct to standard conventional therapy, on insulin resistance (HOMA-IR) and on clinical and biochemical features of PMOS in Bangladeshi women.
A randomised, double-blind, placebo-controlled trial will be conducted at the Department of Pharmacology in collaboration with the Department of Obstetrics \& Gynaecology, Bangladesh Medical University (BMU), Dhaka. Seventy four newly diagnosed women with PMOS (Rotterdam / 2023 ESHRE criteria), aged 18-45 years, will be randomised 1:1 to receive elemental zinc 50 mg/day or an identical-appearing placebo, in addition to standard conventional therapy, for 12 weeks. The primary outcome is change in HOMA-IR from baseline to 12 weeks. Secondary outcomes include change in serum zinc, serum triglycderide, biomarker of oxidative stress (serum malondialdehyde), modified Ferriman-Gallwey (mFG) hirsutism score, BMI, and menstrual regularity. Between-arm comparisons will use unpaired t-tests / Mann-Whitney U; within-arm changes by paired t-tests; categorical outcomes by χ²; and the relationship between change in serum zinc and changes in HOMA-IR, mFG and androgen markers by Pearson / Spearman correlation.
In conclusion, combining zinc supplementation with the conventional treatment might be potentially have a safe, low cost, substantial impact on insulin resistance, lipid profile, oxidative stress and hormonal measures in patients with PMOS.
- Being tested
- Tab. Elemental Zinc 50 mg, Elemental Zinc 50mg
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tab. Elemental Zinc 50 mgDietary supplement
Participants received Tab. Elemental Zinc 50 mg orally once daily for 12 weeks
Elemental Zinc 50mgDietary supplement
Elemental Zinc 50 mg placebo orally once daily for 12 weeks
| Study group | Role | What they receive |
|---|---|---|
| Tab. Elemental Zinc 50 mg | Experimental | Participants received Tab. Elemental Zinc 50 mg orally once daily for 12 weeks Receives: Dietary Supplement: Tab. Elemental Zinc 50 mg |
| Elemental Zinc 50 mg | Placebo comparator | Elemental Zinc 50mg orally once daily for 12 weeks Receives: Dietary Supplement: Elemental Zinc 50mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in Insulin resistances (HOMA-IR)
Measured: 12 weeks
Changes in Plasma Zinc level
Measured: 12 weeks.
Changes in serum Triglycerides
Measured: 12 weeks
Changes in plasma MDA
Measured: 12 weeks
Secondary outcomes (3)
Changes in mFG score for hirsutism
Measured: 12 weeks
Changes in menstrual cycle regularity
Measured: 12 weeks
Changes in BMI
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Sep 2026
- Study startFeb 2027 (estimated)
- Primary completionJun 2027 (estimated)
- Study completionJul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Polyendocrine Metabolic Ovarian Syndrome (PMOS)Studies 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 N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 74 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Bangladesh Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, umme habiba, Bangladesh Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07801001
- Sponsor's protocol ID
- BMU/2026/8387
- Status last verified
- Aug 2026
- First submitted
- 30 Aug 2026
- Last updated
- 2 Sep 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Zinc Supplementation on Insulin Resistance and Clinical Features in Women With Polyendocrine Metabolic Ovarian Syndrome: A Randomized, Double Blind Placebo-Controlled Trial.
- ClinicalTrials.gov ID
- NCT07801001
- Acronym / sponsor ID
- BMU/2026/8387
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 74 participants (estimated)
- Lead sponsor
- Bangladesh Medical UniversityUniversity, hospital or other
- Study start
- Feb 2027 (estimated)
- Primary completion
- Jun 2027 (estimated)
- Study completion
- Jul 2027 (estimated)
- First posted
- 2 Sep 2026 (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.
Polyendocrine Metabolic Ovarian Syndrome (PMOS) is the most common endocrinopathy in women of reproductive age, and is mechanistically anchored in insulin resistance (IR), and drives the downstream cascade of hyperandrogenism, anovulation, dyslipidaemia and long-term type 2 diabetes risk. South Asian women -including Bangladeshi women - develop IR at lower BMI thresholds than other populations and simultaneously carry one of the world's highest burdens of zinc deficiency (57% of non-pregnant non-lactating women). Zinc is structurally required for pancreatic β-cell insulin synthesis, modulates insulin-receptor signaling and PI3K/Akt-mediated glucose uptake, and acts as a cofactor for Cu/Zn-superoxide dismutase, suppressing the oxidative stress and NF-κB-driven inflammation that perpetuate IR in PMOS. Despite this strong mechanistic rationale, no randomised trial of zinc supplementation in PMOS has been conducted in any South Asian population.
To evaluate the effect of 12 weeks of oral zinc supplementation, as adjunct to standard conventional therapy, on insulin resistance (HOMA-IR) and on clinical and biochemical features of PMOS in Bangladeshi women.
A randomised, double-blind, placebo-controlled trial will be conducted at the Department of Pharmacology in collaboration with the Department of Obstetrics \& Gynaecology, Bangladesh Medical University (BMU), Dhaka. Seventy four newly diagnosed women with PMOS (Rotterdam / 2023 ESHRE criteria), aged 18-45 years, will be randomised 1:1 to receive elemental zinc 50 mg/day or an identical-appearing placebo, in addition to standard conventional therapy, for 12 weeks. The primary outcome is change in HOMA-IR from baseline to 12 weeks. Secondary outcomes include change in serum zinc, serum triglycderide, biomarker of oxidative stress (serum malondialdehyde), modified Ferriman-Gallwey (mFG) hirsutism score, BMI, and menstrual regularity. Between-arm comparisons will use unpaired t-tests / Mann-Whitney U; within-arm changes by paired t-tests; categorical outcomes by χ²; and the relationship between change in serum zinc and changes in HOMA-IR, mFG and androgen markers by Pearson / Spearman correlation.
In conclusion, combining zinc supplementation with the conventional treatment might be potentially have a safe, low cost, substantial impact on insulin resistance, lipid profile, oxidative stress and hormonal measures in patients with PMOS.
Detailed description
Polyendocrine Metabolic Ovarian Syndrome (PMOS) is the most common endocrinopathy in women of reproductive age, and is mechanistically anchored in insulin resistance (IR), and drives the downstream cascade of hyperandrogenism, anovulation, dyslipidaemia and long-term type 2 diabetes risk. South Asian women -including Bangladeshi women - develop IR at lower BMI thresholds than other populations and simultaneously carry one of the world's highest burdens of zinc deficiency (57% of non-pregnant non-lactating women). Zinc is structurally required for pancreatic β-cell insulin synthesis, modulates insulin-receptor signaling and PI3K/Akt-mediated glucose uptake, and acts as a cofactor for Cu/Zn-superoxide dismutase, suppressing the oxidative stress and NF-κB-driven inflammation that perpetuate IR in PMOS. Despite this strong mechanistic rationale, no randomised trial of zinc supplementation in PMOS has been conducted in any South Asian population.
To evaluate the effect of 12 weeks of oral zinc supplementation, as adjunct to standard conventional therapy, on insulin resistance (HOMA-IR) and on clinical and biochemical features of PMOS in Bangladeshi women.
A randomised, double-blind, placebo-controlled trial will be conducted at the Department of Pharmacology in collaboration with the Department of Obstetrics \& Gynaecology, Bangladesh Medical University (BMU), Dhaka. Seventy four newly diagnosed women with PMOS (Rotterdam / 2023 ESHRE criteria), aged 18-45 years, will be randomised 1:1 to receive elemental zinc 50 mg/day or an identical-appearing placebo, in addition to standard conventional therapy, for 12 weeks. The primary outcome is change in HOMA-IR from baseline to 12 weeks. Secondary outcomes include change in serum zinc, serum triglycderide, biomarker of oxidative stress (serum malondialdehyde), modified Ferriman-Gallwey (mFG) hirsutism score, BMI, and menstrual regularity. Between-arm comparisons will use unpaired t-tests / Mann-Whitney U; within-arm changes by paired t-tests; categorical outcomes by χ²; and the relationship between change in serum zinc and changes in HOMA-IR, mFG and androgen markers by Pearson / Spearman correlation.
In conclusion, combining zinc supplementation with the conventional treatment might be potentially have a safe, low cost, substantial impact on insulin resistance, lipid profile, oxidative stress and hormonal measures in patients with PMOS.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Tab. Elemental Zinc 50 mg | Experimental | Dietary Supplement: Tab. Elemental Zinc 50 mgParticipants received Tab. Elemental Zinc 50 mg orally once daily for 12 weeks |
| Elemental Zinc 50 mg | Placebo comparator | Dietary Supplement: Elemental Zinc 50mgElemental Zinc 50mg orally once daily for 12 weeks |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- the updated evidence based Rotterdam Criteria (revised 2023)
- newly diagnosed women with PMOS
- age above 18 years upto 45 years
Key exclusion criteria (7 listed)
- Pregnancy and lactating mother.
- diagnosed case of Diabetes mellitus, liver disease, kidney disease, cardiovascular disease
- Any acute or chronic infective or inflammatory disease.
- Patients receiving Zinc supplementation within the last three months.
- Exclusion of PMOS mimicking disease include hyperprolactinemia, adrenal hyperandrogenism, ovarian hyperandrogenism, cushing syndrome, acromegaly etc.
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 |
|---|---|---|
| Tab. Elemental Zinc 50 mgParticipants received Tab. Elemental Zinc 50 mg orally once daily for 12 weeks | Dietary supplement | Tab. Elemental Zinc 50 mg |
| Elemental Zinc 50mgElemental Zinc 50 mg placebo orally once daily for 12 weeks | Dietary supplement | Elemental Zinc 50 mg |
Primary outcome
Changes in Insulin resistances (HOMA-IR)
Time frame: 12 weeks
Changes in Plasma Zinc level
Time frame: 12 weeks.
Changes in serum Triglycerides
Time frame: 12 weeks
Changes in plasma MDA
Time frame: 12 weeks
3 secondary outcomes
Changes in mFG score for hirsutism
Time frame: 12 weeks
Changes in menstrual cycle regularity
Time frame: 12 weeks
Changes in BMI
Time frame: 12 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Sep 2026.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Tab. Elemental Zinc 50 mg and Elemental Zinc 50mg in people with Polyendocrine Metabolic Ovarian Syndrome (PMOS), run by Bangladesh Medical University 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 3 inclusion and 7 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: enrolling by invitation, as of the sponsor's last update on 2 Sep 2026. 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.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
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?
Changes in Insulin resistances (HOMA-IR) (time frame: 12 weeks). The study lists 4 primary outcomes in all. 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 2 Sep 2026.