Inositol-suppletie om PCOS te behandelen (INSUPP-PCOS) (INSUPP-PCOS)
Inositol-suppletie voor de behandeling van polycysteus ovariumsyndroom: een dubbelblinde dosis variërende RCT (INSUPP-PCOS)
To determine if Inositol, a dietary supplement, will improve ovarian and adrenal androgen excess in women with Polycystic Ovarian Syndrome(PCOS).
Studie Overzicht
Toestand
Conditie
Interventie / Behandeling
Gedetailleerde beschrijving
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.
Studietype
Inschrijving (Werkelijk)
Fase
- Fase 2
Contacten en locaties
Studie Locaties
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Pennsylvania
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Hershey, Pennsylvania, Verenigde Staten, 17033
- Penn State College of Medicine, Penn State Milton S. Hershey Medical Center
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Philadelphia, Pennsylvania, Verenigde Staten, 19104
- University of Pennsylvania
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Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
Accepteert gezonde vrijwilligers
Geslachten die in aanmerking komen voor studie
Beschrijving
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.
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Behandeling
- Toewijzing: Gerandomiseerd
- Interventioneel model: Parallelle opdracht
- Masker: Verviervoudigen
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
|---|---|
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Placebo-vergelijker: 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:
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Experimenteel: 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 |
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Experimenteel: 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 |
|
Experimenteel: 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 |
Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
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Total Testosterone
Tijdsspanne: 3 months (baseline, 1 month and 3 month visits)
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Total testosterone levels measured at baseline, 1 month, and 3 month visits. |
3 months (baseline, 1 month and 3 month visits)
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Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
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SHBG
Tijdsspanne: 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)
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Free Androgen Index (FAI)
Tijdsspanne: 3 months (baseline, 1 month and 3 month visits)
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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)
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Area Under the Curve (AUC) of Glucose
Tijdsspanne: 3 months (baseline and 3 month visits)
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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)
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Fasting Insulin
Tijdsspanne: 3 months (baseline and 3 month visits)
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Fasting insulin levels measured at baseline and 3 month visit. |
3 months (baseline and 3 month visits)
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Medewerkers en onderzoekers
Sponsor
Onderzoekers
- Hoofdonderzoeker: Richard S. Legro, M.D., Penn State College of Medicine, Hershey Medical Center
Studie record data
Bestudeer belangrijke data
Studie start (Werkelijk)
Primaire voltooiing (Werkelijk)
Studie voltooiing (Werkelijk)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Werkelijk)
Updates van studierecords
Laatste update geplaatst (Werkelijk)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Trefwoorden
Aanvullende relevante MeSH-voorwaarden
- Urogenitale ziekten
- Genitale ziekten
- Endocriene systeemziekten
- Neoplasmata
- Mannelijke urogenitale ziekten
- Vrouwelijke urogenitale ziekten
- Vrouwelijke urogenitale ziekten en zwangerschapscomplicaties
- Metabole ziekten
- Genitale ziekten, vrouw
- Glucosemetabolismestoornissen
- Ovariële ziekten
- Adnexale ziekten
- Gonadale aandoeningen
- Aangeboren afwijkingen
- Hyperinsulinisme
- Ovariële cysten
- Cysten
- Stoornissen van seksuele ontwikkeling
- Urogenitale afwijkingen
- Hyperglykemie
- 46, XX Aandoeningen van seksuele ontwikkeling
- Adrenogenitaal syndroom
- Aangeboren, erfelijke en neonatale ziekten en afwijkingen
- Voedings- en stofwisselingsziekten
- Polycysteus ovarium syndroom
- Insuline-resistentie
- Glucose intolerantie
- Hyperandrogenisme
- Anovulatie
- Organische chemicaliën
- Koolhydraten in de voeding
- Koolhydraten
- Polymeren
- Macromoleculaire stoffen
- Alcohol
- Polysachariden
- Zetmeel
- Glucanen
- Biopolymeren
- Fructanen
- Suikeralcoholen
- Inositol
- maltodextrin
- Inuline
Andere studie-ID-nummers
- Study00010252
- 1R01AT009484-01A1 (Subsidie/contract van de Amerikaanse NIH)
Informatie over medicijnen en apparaten, studiedocumenten
Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel
Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct
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