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Effect of Magnesium and Levocarnitine on Metabolic and Clinical Outcomes in Women With Polycystic Ovarian Syndrome (PCOS)

Plain-language guide to NCT07298564: not phased randomized trial of L-Carnitine, pcos, 84 participants. Who took part, design and what was measured.

Key Facts

Registry ID
NCT07298564
Phase
not phased
Status
recruiting participants
Start
2026-01-30
Completion (planned or actual)
2026-10-30
Participants
84 (estimated)
Design
randomized, triple-blind, treatment
Conditions studied
Polycystic Ovary Syndrome (PCOS)
Results posted
not yet

What This Study Did, in Plain Language

What Was Tested

In this not phased trial, researchers set out to test L-Carnitine for pcos.

It had three arms (groups): one (experimental), one (experimental) and Placebo (placebo comparator).

Placebo capsules matching magnesium and Levocarnitine for 12 weeks.

The registry classes the interventions as dietary supplement.

More on the Plan

This is a randomized, triple-blind, parallel clinical trial evaluates the effects of co-supplementation with Magnesium and Levocarnitine on metabolic and hormonal outcomes in women with Polycystic Ovary Syndrome (PCOS).

Then the body mass index, waist circumference, systolic and diastolic blood pressure, Fasting Blood Sugar (FBS), lipid profile, Hemoglobin A1c (HbA1C), serum insulin concentration and insulin resistance are measured; All assessments will be performed at baseline and at the end of the study.

Who Took Part

84 planned participants were the target.

It was open to women only aged from 19 years up to 65 years.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: Age between 19 and 65 years. Diagnosis of polycystic ovary syndrome (PCOS) according to the Rotterdam criteria.

The full record lists 2 inclusion and 10 exclusion criteria; among the exclusions: pregnancy or breastfeeding; renal (kidney) dysfunction; use of therapeutic vitamin or mineral supplements.

How the Study Was Run

It was run as a randomized, parallel-group and triple-blind study.

Because people in this L-Carnitine study were split into groups at random, differences between the groups are less likely to reflect who happened to join each one.

Groups ran in parallel: each of the pcos participants stayed in one arm throughout.

Blinding on both sides kept the pcos participants and researchers unaware of who received L-Carnitine.

Those kept unaware of assignments: participant, care provider and investigator.

It started in 2026-01-30 with completion listed for 2026-10-30.

It ran at 1 site in Iran.

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Change from Baseline of FBS (time frame: Baseline and 12 weeks after).

It also tracked 7 secondary outcomes, for example Change from Baseline of serum insulin, Change from baseline of HbA1c, Change from baseline of HOMA-IR, Change from baseline of total cholesterol, Change from baseline of Triglyceride and Change from baseline of low density lipoprotein cholesterol (LDL-Cholesterol).

What This Means in Plain Language

Put simply, this is a not phased, randomized trial of L-Carnitine in 84 people with pcos.

It is still recruiting; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the L-Carnitine compound page, PCOS research.

Our Notes on the Compound

L-Carnitine: An amino acid derivative that carries fatty acids into mitochondria for energy production.

Related Pages

Source: ClinicalTrials.gov record. This explanation is written by PeptideWhiz from the public record. For research and education only. Not medical advice; no dosing information is given.