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.
調査の概要
詳細な説明
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.
研究の種類
入学 (推定)
段階
- 適用できない
連絡先と場所
研究連絡先
- 名前：Kaleem A Dr, FCPS
- 電話番号：+92-302-4750515
- メール：sara.qmc@qamc.edu.pk
研究場所
-
-
Punjab Province
-
Chak Four Hundred Fifty-four、Punjab Province、パキスタン、63100
- Sadiq Abbasi Hospital/ Quaid-e-Azam Medical College
-
-
参加基準
適格基準
就学可能な年齢
- 大人
健康ボランティアの受け入れ
説明
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.
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：処理
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
アクティブコンパレータ：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.
|
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.
|
|
実験的：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.
|
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.
|
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Spontaneous Conception Rate
時間枠：12 weeks
|
Proportion of participants achieving spontaneous conception without ovulation induction or assisted reproductive technologies, confirmed by a positive urinary pregnancy test.
|
12 weeks
|
|
Achievement of Menstrual Regularity
時間枠：12 weeks
|
Proportion of participants achieving regular menstrual cycles of 21 to 35 days during the treatment period.
|
12 weeks
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Change in Body Mass Index
時間枠：Baseline and 12 weeks
|
Change in body mass index (kg/m²) from baseline to week 12.
|
Baseline and 12 weeks
|
|
Change in Serum Luteinizing Hormone Level
時間枠：Baseline and 12 weeks
|
Change in serum luteinizing hormone concentration from baseline to week 12.
|
Baseline and 12 weeks
|
|
Change in LH/FSH Ratio
時間枠：Baseline and 12 weeks
|
Change in luteinizing hormone to follicle-stimulating hormone ratio from baseline to week 12.
|
Baseline and 12 weeks
|
|
Change in Fasting Glucose
時間枠：Baseline and 12 weeks
|
Change in fasting glucose level from baseline to week 12.
|
Baseline and 12 weeks
|
|
Change in Fasting Insulin
時間枠：Baseline and 12 weeks
|
Change in fasting insulin level from baseline to week 12.
|
Baseline and 12 weeks
|
|
Change in HOMA-IR
時間枠：Baseline and 12 weeks
|
Change in insulin resistance assessed by Homeostatic Model Assessment of Insulin Resistance (HOMA-IR) from baseline to week 12.
|
Baseline and 12 weeks
|
|
Treatment Adherence
時間枠：12 weeks
|
Proportion of participants with good treatment adherence (≥80% of prescribed doses).
|
12 weeks
|
|
Incidence of Adverse Events
時間枠：12 weeks
|
Frequency and type of treatment-related adverse events during the intervention period.
|
12 weeks
|
|
Change in Modified Ferriman-Gallwey Score
時間枠：Baseline and 12 weeks
|
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.
|
Baseline and 12 weeks
|
協力者と研究者
捜査官
- スタディチェア：Saba Nadeem, FCPS、Sadiq Abbasi Hospital/Quaid-e-Azam Medical College
出版物と役立つリンク
一般刊行物
- 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.
研究記録日
主要日程の研究
研究開始 (推定)
一次修了 (推定)
研究の完了 (推定)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
追加の関連 MeSH 用語
その他の研究ID番号
- OBG-2025-033-14500
- 509/DME/QAMC Bahawalpur (その他の識別子：Quaid-e-Azam Medical College)
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
IPD プランの説明
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。