Clinical trial · Interventional
Myo-inositol, Alpha-Lactalbumin and Folic Acid Treatment in PCOS
Effects of Myo-inositol, Alpha-Lactalbumin and Folic Acid Treatment in PCOS Women of Mexico and Italy
NCT04645745CI-TRIAL-00049419completedN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The main aim of this study is to evaluate the effect of myo-inositol and alpha-lactalbumin treatment on HOMA-index improvement in two different groups of women, belonging to the Mexican and Italian population, both affected by Polycystic Ovary Syndrome.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Polycystic Ovary Syndrome | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| myo-inositol, alpha-lactalbumin, folic acid | Dietary Supplement | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- myo-inositol plus alpha-lactalbumin
- description
- Patients were treated with 2 g myo-inositol, 50 mg alpha-LA and 200 mcg of Folic Acid twice a day for 6 months. Controls were the same patients at baseline (t0)
- interventionNames
- Dietary Supplement: myo-inositol, alpha-lactalbumin, folic acid
Primary outcomes (1)
- measure
- Evaluation of Myo-inositol and alpha-lactalbumin treatment on HOMA-index
- timeFrame
- three and six months
- description
- monitoring glucose and insulin levels in blood
Secondary outcomes (2)
- measure
- Evaluation of Myo-inositol and alpha-lactalbumin treatment on ovulation
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 40 Years
Show eligibility criteria text
Inclusion Criteria: * PCOS diagnosis based on the Rotterdam ESHRE-ASRM consensus workshop group1. * Presence of Insulin resistance diagnosed by HOMA-Index * Patients belonging to the Mexican population * Patients belonging to the Italian population Exclusion Criteria: * BMI ≥ 30 * Other conditions causing ovulatory disorders and/or androgens hyper production such as: hyperprolactinemia, hypothyroidism, adrenal hyperplasia and Cushing syndrome * Hormonal and/or pharmacological treatments in the previous 3 months that could interfere with ovulation * Drastic changes in diet and physical activity * Treatment with products containing inositols in the previous 3 months
References
Publications (0)
Data not yet available
No reference posted for this study.