Inositoltilskud til behandling af PCOS (INSUPP-PCOS) (INSUPP-PCOS)
Inositoltilskud til behandling af polycystisk ovariesyndrom: En dobbeltblind dosis varierende RCT (INSUPP-PCOS)
To determine if Inositol, a dietary supplement, will improve ovarian and adrenal androgen excess in women with Polycystic Ovarian Syndrome(PCOS).
Studieoversigt
Status
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
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.
Undersøgelsestype
Tilmelding (Faktiske)
Fase
- Fase 2
Kontakter og lokationer
Studiesteder
-
-
Pennsylvania
-
Hershey, Pennsylvania, Forenede Stater, 17033
- Penn State College of Medicine, Penn State Milton S. Hershey Medical Center
-
Philadelphia, Pennsylvania, Forenede Stater, 19104
- University of Pennsylvania
-
-
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
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.
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Firedobbelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
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
Andre navne:
|
|
Eksperimentel: 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 |
|
Eksperimentel: 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 |
|
Eksperimentel: 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 |
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Total Testosterone
Tidsramme: 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)
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
SHBG
Tidsramme: 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)
Tidsramme: 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
Tidsramme: 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
Tidsramme: 3 months (baseline and 3 month visits)
|
Fasting insulin levels measured at baseline and 3 month visit. |
3 months (baseline and 3 month visits)
|
Samarbejdspartnere og efterforskere
Sponsor
Samarbejdspartnere
Efterforskere
- Ledende efterforsker: Richard S. Legro, M.D., Penn State College of Medicine, Hershey Medical Center
Datoer for undersøgelser
Studer store datoer
Studiestart (Faktiske)
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
- Urogenitale sygdomme
- Genitale sygdomme
- Sygdomme i det endokrine system
- Neoplasmer
- Mandlige urogenitale sygdomme
- Urogenitale sygdomme hos kvinder
- Kvinders urogenitale sygdomme og graviditetskomplikationer
- Metaboliske sygdomme
- Kønssygdomme, kvindelige
- Glukosemetabolismeforstyrrelser
- Ovariesygdomme
- Adnexale sygdomme
- Gonadale lidelser
- Medfødte abnormiteter
- Hyperinsulinisme
- Ovariecyster
- Cyster
- Forstyrrelser i seksuel udvikling
- Urogenitale abnormiteter
- Hyperglykæmi
- 46, XX Forstyrrelser i kønsudvikling
- Adrenogenital syndrom
- Medfødte, arvelige og neonatale sygdomme og abnormiteter
- Ernæringsmæssige og metaboliske sygdomme
- Polycystisk ovariesyndrom
- Insulin resistens
- Glucoseintolerance
- Hyperandrogenisme
- Anovulation
- Organiske kemikalier
- Diætkulhydrater
- Kulhydrater
- Polymerer
- Makromolekylære stoffer
- Alkoholer
- Polysaccharider
- Stivelse
- Glukaner
- Biopolymerer
- Fruktaner
- Sukkeralkoholer
- Inositol
- maltodextrin
- Inulin
Andre undersøgelses-id-numre
- Study00010252
- 1R01AT009484-01A1 (U.S. NIH-bevilling/kontrakt)
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
Studerer et amerikansk FDA-reguleret enhedsprodukt
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .