Nutritional and Metabolic Diseases

All Conditions

Symptoms and General Pathology

Neoplasms

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Gland and Hormone Related Diseases

Diseases and Abnormalities at or Before Birth

Rare Diseases

Glucose Intolerance

Syndrome

Polycystic Ovary Syndrome

Insulin Resistance

Hyperandrogenism

Anovulation

Hyperinsulinism

Metabolic Diseases

Glucose Metabolism Disorders

Cysts

Ovarian Cysts

Ovarian Diseases

Adnexal Diseases

Genital Diseases, Female

Genital Diseases

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Gonadal Disorders

Endocrine System Diseases

Hyperglycemia

Disorders of Sex Development

46, XX Disorders of Sex Development

Congenital Abnormalities

Urogenital Abnormalities

Adrenal Hyperplasia, Congenital

Adrenogenital Syndrome

Male Urogenital Diseases

Congenital Adrenal Hyperplasia

21-hydroxylase Deficiency

Hypoglycemic Agents

All Drugs and Chemicals

Micronutrients

Hematinics

Other Dietary Supplements

Vitamins

Insulin

Insulin, Globin Zinc

Inositol

Folic Acid

Vitamin B Complex

Trace Elements

Inulin

Folate

Vitamin B9

Women with PCOS (N = 30) will receive the daily placebo (maltodextrin and inulin) in an identical fashion as the active study group and will be monitored the same.

Women with PCOS (N = 30) 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.

Women with PCOS (N = 30) 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.

Women with PCOS (N = 30) 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.

Placebo

1gm/bid, 2gm/bid or 3gm/bid of Inositol powder

Amyee McMonagle, BSN

Sandra Eyer

Richard S. Legro, M.D.

Richard S Legro, M.D.

Claire Webb

Andrea Morley

Anuja Dokras, MD, PhD

To determine if Inositol, a dietary supplement, will improve ovarian and adrenal androgen excess in women with Polycystic Ovarian Syndrome(PCOS).

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.

Placebo Group; Active Treatment with Inositol 1gm/bid; Active Treatment with Inositol 2gm/bid; Active Treatment with Inositol 3gm/ bid

PCOS is a disorder that only affects women and therefore men are not eligible to participate in this study.

Inositol Supplementation to Treat PCOS (INSUPP-PCOS)

Inositol Supplementation to Treat Polycystic Ovary Syndrome: A Double Blind Dose Ranging RCT (INSUPP-PCOS)

AUC of a 2-hour 75g glucose tolerance test, which measures glucose at 0, 30, 60, 90, and 120 minutes.

National Center for Complementary and Integrative Health (NCCIH)

Milton S. Hershey Medical Center

Chair, Obstetrics and Gynecology

Spots Global Cancer Trial Database for metabolic complication