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Effect of Zinc Supplementation on Insulin Resistance and Clinical Features in Women With Polyendocrine Metabolic Ovarian Syndrome.

NCT07801001 · Status: ENROLLING_BY_INVITATION · Phase: NA · Type: INTERVENTIONAL · Enrollment: 74

Last updated 2026-09-02

No results posted yet for this study

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. 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.

Conditions

  • Polyendocrine Metabolic Ovarian Syndrome (PMOS)

Interventions

DIETARY_SUPPLEMENT

Tab. Elemental Zinc 50 mg

Participants received Tab. Elemental Zinc 50 mg orally once daily for 12 weeks

DIETARY_SUPPLEMENT

Elemental Zinc 50mg

Elemental Zinc 50 mg placebo orally once daily for 12 weeks

Sponsors & Collaborators

  • Bangladesh Medical University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2027-02-28
Primary Completion
2027-06-30
Completion
2027-07-31

Countries

  • Bangladesh

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07801001 on ClinicalTrials.gov