Inositol-Ergänzung zur Behandlung von PCOS (INSUPP-PCOS) (INSUPP-PCOS)
Inositol-Ergänzung zur Behandlung des polyzystischen Ovarialsyndroms: Eine Double Blind Dose Ranging RCT (INSUPP-PCOS)
To determine if Inositol, a dietary supplement, will improve ovarian and adrenal androgen excess in women with Polycystic Ovarian Syndrome(PCOS).
Studienübersicht
Status
Bedingungen
Intervention / Behandlung
Detaillierte Beschreibung
This trial will test prospectively the effects of inositol supplementation in a dose ranging double blind randomized controlled trial, according to CONSORT guidelines. This will be a four armed study of three doses of inositol vs. placebo over a three month period with the reduction in hyperandrogenism (based on serum testosterone levels) as the primary outcome and key secondary outcomes of the change in sex hormone binding globulin(SHBG) and the related free androgen index, fasting insulin levels and area under the curve glucose levels from an oral glucose challenge test (OGTT). The hypothesis is that women with PCOS who receive inositol supplementation will have a dose related reduction in hyperandrogenism. Further, we propose that the primary mechanism of inositol will be a significant improvement in hyperandrogenism (both ovarian and adrenal) vs. placebo, as documented by a lower free androgen index [decreased total testosterone and increased sex hormone blinding globulin (SHBG)], lower sebum measures and lower antral follicle counts of the ovary and anti-Mullerian hormone, all of which will correlate with the decrease in hyperandrogenism.
Studientyp
Einschreibung (Tatsächlich)
Phase
- Phase 2
Kontakte und Standorte
Studienorte
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Pennsylvania
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Hershey, Pennsylvania, Vereinigte Staaten, 17033
- Penn State College of Medicine, Penn State Milton S. Hershey Medical Center
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Philadelphia, Pennsylvania, Vereinigte Staaten, 19104
- University of Pennsylvania
-
-
Teilnahmekriterien
Zulassungskriterien
Studienberechtigtes Alter
Akzeptiert gesunde Freiwillige
Studienberechtigte Geschlechter
Beschreibung
Inclusion Criteria:
- Women with chronic anovulation or oligomenorrhea defined as spontaneous intermenstrual periods of greater than or equal to 45 days or a total of less than or equal to 8 menses per year.
- Women with Hyperandrogenism defined as a total testosterone greater than 50 ng/dL or a free androgen index greater than 10.
- Women with Polycystic Ovaries on Ultrasound defined as either 12 or more follicles measuring 2-9 mm in diameter or increased ovarian volume greater than 10 cm.
Exclusion Criteria:
- Women with Hyperprolactinemia defined as 2 prolactin levels at least one week apart greater than 30 ng/mL.
- Women with known 21-hydroxylase deficiency or other enzyme deficiency leading to the congenital adrenal hyperplasia.
- Women with elevated FSH levels greater than 10 mIU/mL.
- Women with uncorrected thyroid disease as per ASRM guidelines for nonpregnant subjects (TSH less than 0.45 mIU/mL or greater than 4.5 MIU/mL).
- Women with a suspected adrenal or ovarian tumor secreting androgens
- Women with Cushing's syndrome
- Women on confounding medications which affect ovarian function including metformin, hormonal contraceptives or other medications for type 2 diabetes
- Women with medical conditions that are contraindications to OTC inositol or previous allergic reactions to the supplement or to the placebo maltodextrin or inulin.
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Behandlung
- Zuteilung: Zufällig
- Interventionsmodell: Parallele Zuordnung
- Maskierung: Vervierfachen
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
|---|---|
|
Placebo-Komparator: Placebo Treatment bid
Women with PCOS will receive the daily placebo (maltodextrin and inulin) in an identical fashion as the active study group and will be monitored the same. |
Placebo
Andere Namen:
|
|
Experimental: Active Treatment with Inositol 1gm/bid
Women with PCOS will receive daily inositol powder BID as active drug (each dose with 1000 mg of myo-inositol and 25 mg of d-chiro-inositol) over the initial 3 mos RCT period. |
1gm/bid, 2gm/bid or 3gm/bid of Inositol powder |
|
Experimental: Active Treatment with Inositol 2 gm/bid
Women with PCOS will receive daily inositol powder BID as active drug (each dose with 2000 mg of myo-inositol and 50 mg of d-chiro-inositol) over the initial 3 mos RCT period. |
1gm/bid, 2gm/bid or 3gm/bid of Inositol powder |
|
Experimental: Active Treatment with Inositol 3 gm/bid
Women with PCOS will receive daily inositol powder BID as active drug (each dose with 3000 mg of myo-inositol and 75 mg of d-chiro-inositol) over the initial 3 mos RCT period. |
1gm/bid, 2gm/bid or 3gm/bid of Inositol powder |
Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
Total Testosterone
Zeitfenster: 3 months (baseline, 1 month and 3 month visits)
|
Total testosterone levels measured at baseline, 1 month, and 3 month visits. |
3 months (baseline, 1 month and 3 month visits)
|
Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
SHBG
Zeitfenster: 3 months (baseline, 1 month and 3 month visits)
|
Sex hormone-binding globulin (SHBG) levels measured at baseline, 1 month, and 3 month visits. |
3 months (baseline, 1 month and 3 month visits)
|
|
Free Androgen Index (FAI)
Zeitfenster: 3 months (baseline, 1 month and 3 month visits)
|
Free Androgen Index calculated at baseline, 1 month, and 3 month visits. FAI is calculated as (testosterone/SHBG)*100 (after converting testosterone to the same units as SHBG) |
3 months (baseline, 1 month and 3 month visits)
|
|
Area Under the Curve (AUC) of Glucose
Zeitfenster: 3 months (baseline and 3 month visits)
|
AUC of a 2-hour 75g glucose tolerance test, which measures glucose at 0, 30, 60, 90, and 120 minutes. AUC was calculated at baseline and 3 month visit. |
3 months (baseline and 3 month visits)
|
|
Fasting Insulin
Zeitfenster: 3 months (baseline and 3 month visits)
|
Fasting insulin levels measured at baseline and 3 month visit. |
3 months (baseline and 3 month visits)
|
Mitarbeiter und Ermittler
Sponsor
Ermittler
- Hauptermittler: Richard S. Legro, M.D., Penn State College of Medicine, Hershey Medical Center
Studienaufzeichnungsdaten
Haupttermine studieren
Studienbeginn (Tatsächlich)
Primärer Abschluss (Tatsächlich)
Studienabschluss (Tatsächlich)
Studienanmeldedaten
Zuerst eingereicht
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst gepostet (Tatsächlich)
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Zuletzt verifiziert
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Schlüsselwörter
Zusätzliche relevante MeSH-Bedingungen
- Urogenitale Erkrankungen
- Genitalerkrankungen
- Erkrankungen des endokrinen Systems
- Neubildungen
- Männliche Urogenitalerkrankungen
- Weibliche Urogenitalerkrankungen
- Weibliche Urogenitalerkrankungen und Schwangerschaftskomplikationen
- Stoffwechselerkrankungen
- Genitalerkrankungen, weiblich
- Störungen des Glukosestoffwechsels
- Eierstockerkrankungen
- Adnexerkrankungen
- Gonadenstörungen
- Angeborene Anomalien
- Hyperinsulinismus
- Eierstockzysten
- Zysten
- Störungen der Geschlechtsentwicklung
- Urogenitale Anomalien
- Hyperglykämie
- 46, XX Störungen der Geschlechtsentwicklung
- Adrenogenitales Syndrom
- Angeborene, erbliche und neonatale Krankheiten und Anomalien
- Ernährungs- und Stoffwechselerkrankungen
- PCO-Syndrom
- Insulinresistenz
- Glukose Intoleranz
- Hyperandrogenismus
- Anovulation
- Organische Chemikalien
- Ernährungskohlenhydrate
- Kohlenhydrate
- Polymere
- Makromolekulare Substanzen
- Alkohole
- Polysaccharide
- Stärke
- Glucans
- Biopolymere
- Fructans
- Zuckeralkohole
- Inosit
- Maltodextrin
- Inulin
Andere Studien-ID-Nummern
- Study00010252
- 1R01AT009484-01A1 (US NIH Stipendium/Vertrag)
Arzneimittel- und Geräteinformationen, Studienunterlagen
Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt
Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt
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