An interventional study of Tab. Elemental Zinc 50 mg and Elemental Zinc 50mg in Polyendocrine Metabolic Ovarian Syndrome (PMOS), sponsored by Bangladesh Medical University. Enrolling by invitation at 1 site in Bangladesh. Open to female participants aged 18 Years to 45 Years. Per ClinicalTrials.gov, last updated 2026-09-02.
Sponsored by Bangladesh Medical University · Not applicable, Interventional, and Supportive care
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.
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.
Bangladesh Medical University is the lead sponsor of 43 studies on the registry; 26 are open to participants now.
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Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants received Tab. Elemental Zinc 50 mg orally once daily for 12 weeks
Dietary Supplement: Tab. Elemental Zinc 50 mg
Elemental Zinc 50mg orally once daily for 12 weeks
Dietary Supplement: Elemental Zinc 50mg
Participants received Tab. Elemental Zinc 50 mg orally once daily for 12 weeks
Elemental Zinc 50 mg placebo orally once daily for 12 weeks
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
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
Plan to share: No
No publications or documents are linked to this record.
Start is estimated for Feb 2027; primary completion for Jun 2027, 4 months later.
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Bangladesh Medical University