Myo-Inositol Alone Versus Myo-Inositol Plus Alpha-Lactalbumin in Women With Polycystic Ovary Syndrome (MIALA-PCOS)
Comparison of Efficacy of Myo-Inositol Alone With Myo-Inositol Plus Alpha-Lactalbumin on Reproductive and Metabolic Parameters in Polycystic Ovarian Syndrome
Polycystic ovary syndrome (PCOS) is a common endocrine disorder affecting reproductive-aged women and is associated with menstrual irregularities, infertility, hyperandrogenism, obesity, and insulin resistance. Myo-inositol is commonly used as an insulin-sensitizing agent to improve reproductive and metabolic outcomes in women with PCOS. Alpha-lactalbumin may enhance the intestinal absorption and bioavailability of myo-inositol and potentially improve treatment response.
This randomized controlled trial aims to compare the efficacy of myo-inositol alone versus myo-inositol plus alpha-lactalbumin in women with PCOS. Eighty-two eligible women will be randomized to receive either myo-inositol alone or myo-inositol combined with alpha-lactalbumin for 12 weeks. The study will evaluate reproductive outcomes including spontaneous conception, menstrual regularity, hirsutism, and hormonal parameters, as well as metabolic outcomes including body mass index and insulin resistance.
Przegląd badań
Status
Interwencja / Leczenie
Szczegółowy opis
Polycystic ovary syndrome (PCOS) is one of the most common endocrine disorders among women of reproductive age and is characterized by ovulatory dysfunction, hyperandrogenism, and polycystic ovarian morphology. Insulin resistance plays a central role in the pathophysiology of PCOS and contributes to reproductive and metabolic abnormalities. Consequently, insulin-sensitizing therapies are increasingly used to improve clinical outcomes.
Myo-inositol is an insulin-sensitizing agent that has demonstrated beneficial effects on ovulation, menstrual regularity, endocrine function, and metabolic parameters in women with PCOS. However, some patients demonstrate a suboptimal response to myo-inositol alone. Alpha-lactalbumin, a whey protein fraction, has been reported to enhance intestinal absorption and bioavailability of myo-inositol, potentially leading to improved therapeutic outcomes.
This study is a prospective randomized controlled trial conducted at the Department of Obstetrics and Gynecology, Sadiq Abbasi Hospital, Quaid-e-Azam Medical College, Bahawalpur, Pakistan. A total of 82 women aged 18 to 35 years diagnosed with PCOS according to the Rotterdam criteria will be enrolled and randomized in a 1:1 ratio into two treatment groups.
Participants in Group A will receive myo-inositol 2 g orally twice daily with folic acid supplementation. Participants in Group B will receive myo-inositol 2 g plus alpha-lactalbumin 50 mg orally twice daily with folic acid supplementation. Both groups will receive standardized lifestyle and dietary counseling. The treatment duration will be 12 weeks.
The primary outcomes will be spontaneous conception and achievement of menstrual regularity at 12 weeks. Secondary outcomes will include changes in modified Ferriman-Gallwey score, serum luteinizing hormone levels, LH/FSH ratio, body mass index, fasting glucose, fasting insulin, and homeostatic model assessment of insulin resistance (HOMA-IR). Treatment adherence and adverse events will also be assessed.
The study aims to generate local evidence regarding the comparative effectiveness of myo-inositol alone versus myo-inositol combined with alpha-lactalbumin in improving reproductive and metabolic outcomes among women with PCOS.
Typ studiów
Zapisy (Szacowany)
Faza
- Nie dotyczy
Kontakty i lokalizacje
Kontakt w sprawie studiów
- Nazwa: Kaleem A Dr, FCPS
- Numer telefonu: +92-302-4750515
- E-mail: sara.qmc@qamc.edu.pk
Lokalizacje studiów
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Punjab Province
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Chak Four Hundred Fifty-four, Punjab Province, Pakistan, 63100
- Sadiq Abbasi Hospital/ Quaid-e-Azam Medical College
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Kryteria uczestnictwa
Kryteria kwalifikacji
Wiek uprawniający do nauki
- Dorosły
Akceptuje zdrowych ochotników
Opis
Inclusion Criteria:
- Female participants aged 18 to 35 years.
- Diagnosed with polycystic ovary syndrome according to Rotterdam criteria.
- Diagnosis of PCOS for at least 6 months before enrollment.
- Willing to conceive.
- Normal husband semen analysis.
Exclusion Criteria:
- Pre-existing diabetes mellitus.
- Thyroid dysfunction.
- Hyperprolactinemia.
- Cushing syndrome.
- Congenital adrenal hyperplasia.
- Androgen-secreting adrenal or ovarian tumors.
- Conditions causing ovulatory dysfunction and/or hyperandrogenism other than PCOS.
- Use of ovulation-induction agents, hormonal therapy, insulin sensitizers, or anti-androgens within the previous 12 weeks.
- Morbid obesity (BMI ≥40 kg/m²).
- Known cow milk protein allergy, hypersensitivity to study medications, or severe gastrointestinal malabsorption.
- Hepatic, renal, or cardiovascular impairment.
- Tubal factor infertility.
- Endometriosis.
- Structural uterine abnormality.
- Male factor infertility.
Plan studiów
Jak projektuje się badanie?
Szczegóły projektu
- Główny cel: Leczenie
- Przydział: Randomizowane
- Model interwencyjny: Przydział równoległy
- Maskowanie: Brak (otwarta etykieta)
Broń i interwencje
Grupa uczestników / Arm |
Interwencja / Leczenie |
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Aktywny komparator: Myo-Inositol Alone
Participants will receive myo-inositol 2 g orally twice daily plus folic acid 400 micrograms daily for 12 weeks.
Standardized lifestyle and dietary counseling will be provided.
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Myo-inositol 2 g administered orally twice daily for 12 weeks.
Participants receiving this intervention will also receive folic acid supplementation and standardized lifestyle and dietary counseling.
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Eksperymentalny: Myo-Inositol Plus Alpha-Lactalbumin
Participants will receive myo-inositol 2 g plus alpha-lactalbumin 50 mg orally twice daily and folic acid 400 micrograms daily for 12 weeks.
Standardized lifestyle and dietary counseling will be provided.
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Myo-inositol 2 g administered orally twice daily for 12 weeks.
Participants receiving this intervention will also receive folic acid supplementation and standardized lifestyle and dietary counseling.
Alpha-lactalbumin 50 mg administered orally twice daily in combination with myo-inositol for 12 weeks.
Participants receiving this intervention will also receive folic acid supplementation and standardized lifestyle and dietary counseling.
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Co mierzy badanie?
Podstawowe miary wyniku
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
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Spontaneous Conception Rate
Ramy czasowe: 12 weeks
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Proportion of participants achieving spontaneous conception without ovulation induction or assisted reproductive technologies, confirmed by a positive urinary pregnancy test.
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12 weeks
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Achievement of Menstrual Regularity
Ramy czasowe: 12 weeks
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Proportion of participants achieving regular menstrual cycles of 21 to 35 days during the treatment period.
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12 weeks
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Miary wyników drugorzędnych
Miara wyniku |
Opis środka |
Ramy czasowe |
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Change in Body Mass Index
Ramy czasowe: Baseline and 12 weeks
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Change in body mass index (kg/m²) from baseline to week 12.
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Baseline and 12 weeks
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Change in Serum Luteinizing Hormone Level
Ramy czasowe: Baseline and 12 weeks
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Change in serum luteinizing hormone concentration from baseline to week 12.
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Baseline and 12 weeks
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Change in LH/FSH Ratio
Ramy czasowe: Baseline and 12 weeks
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Change in luteinizing hormone to follicle-stimulating hormone ratio from baseline to week 12.
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Baseline and 12 weeks
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Change in Fasting Glucose
Ramy czasowe: Baseline and 12 weeks
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Change in fasting glucose level from baseline to week 12.
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Baseline and 12 weeks
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Change in Fasting Insulin
Ramy czasowe: Baseline and 12 weeks
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Change in fasting insulin level from baseline to week 12.
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Baseline and 12 weeks
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Change in HOMA-IR
Ramy czasowe: Baseline and 12 weeks
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Change in insulin resistance assessed by Homeostatic Model Assessment of Insulin Resistance (HOMA-IR) from baseline to week 12.
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Baseline and 12 weeks
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Treatment Adherence
Ramy czasowe: 12 weeks
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Proportion of participants with good treatment adherence (≥80% of prescribed doses).
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12 weeks
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Incidence of Adverse Events
Ramy czasowe: 12 weeks
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Frequency and type of treatment-related adverse events during the intervention period.
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12 weeks
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Change in Modified Ferriman-Gallwey Score
Ramy czasowe: Baseline and 12 weeks
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Change in Modified Ferriman-Gallwey (mFG) score from baseline to week 12.
The Modified Ferriman-Gallwey scale measures the degree of hirsutism and ranges from 0 to 36, with higher scores indicating greater severity of hirsutism and worse clinical status.
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Baseline and 12 weeks
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Współpracownicy i badacze
Sponsor
Śledczy
- Krzesło do nauki: Saba Nadeem, FCPS, Sadiq Abbasi Hospital/Quaid-e-Azam Medical College
Publikacje i pomocne linki
Publikacje ogólne
- Fitz V, Graca S, Mahalingaiah S, Liu J, Lai L, Butt A, Armour M, Rao V, Naidoo D, Maunder A, Yang G, Vaddiparthi V, Witchel SF, Pena A, Spritzer PM, Li R, Tay C, Mousa A, Teede H, Ee C. Inositol for Polycystic Ovary Syndrome: A Systematic Review and Meta-analysis to Inform the 2023 Update of the International Evidence-based PCOS Guidelines. J Clin Endocrinol Metab. 2024 May 17;109(6):1630-1655. doi: 10.1210/clinem/dgad762.
- Teede HJ, Tay CT, Laven JJE, Dokras A, Moran LJ, Piltonen TT, Costello MF, Boivin J, Redman LM, Boyle JA, Norman RJ, Mousa A, Joham AE. Recommendations From the 2023 International Evidence-based Guideline for the Assessment and Management of Polycystic Ovary Syndrome. J Clin Endocrinol Metab. 2023 Sep 18;108(10):2447-2469. doi: 10.1210/clinem/dgad463.
- Kamenov Z, Gateva A, Dinicola S, Unfer V. Comparing the Efficacy of Myo-Inositol Plus alpha-Lactalbumin vs. Myo-Inositol Alone on Reproductive and Metabolic Disturbances of Polycystic Ovary Syndrome. Metabolites. 2023 May 31;13(6):717. doi: 10.3390/metabo13060717.
Daty zapisu na studia
Główne daty studiów
Rozpoczęcie studiów (Szacowany)
Zakończenie podstawowe (Szacowany)
Ukończenie studiów (Szacowany)
Daty rejestracji na studia
Pierwszy przesłany
Pierwszy przesłany, który spełnia kryteria kontroli jakości
Pierwszy wysłany (Rzeczywisty)
Aktualizacje rekordów badań
Ostatnia wysłana aktualizacja (Rzeczywisty)
Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości
Ostatnia weryfikacja
Więcej informacji
Terminy związane z tym badaniem
Słowa kluczowe
Dodatkowe istotne warunki MeSH
- Choroby układu moczowo-płciowego
- Choroby narządów płciowych
- Choroby układu hormonalnego
- Nowotwory
- Choroby układu moczowo-płciowego kobiet
- Choroby układu moczowo-płciowego kobiet i powikłania ciąży
- Choroby narządów płciowych, kobiety
- Choroby jajników
- Choroby przydatków
- Zaburzenia gonad
- Torbiele jajników
- Cysty
- Zespół policystycznych jajników
- Bezpłodność
- Aminokwasy, peptydy i białka
- Białka
- Organiczne chemikalia
- Węglowodany
- Alkohole
- Albuminy
- Alkohole cukrowe
- Białka dietetyczne
- Białka mleczne
- Białka zwierzęce, dieta
- Białka serwatki
- Inozytol
- Laktalbumina
Inne numery identyfikacyjne badania
- OBG-2025-033-14500
- 509/DME/QAMC Bahawalpur (Inny identyfikator: Quaid-e-Azam Medical College)
Plan dla danych uczestnika indywidualnego (IPD)
Planujesz udostępniać dane poszczególnych uczestników (IPD)?
Opis planu IPD
Informacje o lekach i urządzeniach, dokumenty badawcze
Bada produkt leczniczy regulowany przez amerykańską FDA
Bada produkt urządzenia regulowany przez amerykańską FDA
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