Clinical trial NCT03864068: Inositol Supplementation to Treat PCOS (INSUPP-PCOS)
Official title: Inositol Supplementation to Treat Polycystic Ovary Syndrome: A Double Blind Dose Ranging RCT (INSUPP-PCOS)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Polycystic Ovary Syndrome
Anovulation
Hyperandrogenism
Insulin Resistance
Glucose Intolerance
Metabolic Complication
Keywords: Polycystic Ovary Syndrome
Anovulation
Hyperandrogenism
Insulin Resistance
Glucose Intolerance
Metabolic Complication
Lead sponsor: Milton S. Hershey Medical Center
Sponsor class: OTHER
Collaborators: name: National Center for Complementary and Integrative Health (NCCIH)
First posted: 2019-03-06
Enrollment: 128
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Placebo Group; Active Treatment with Inositol 1gm/bid; Active Treatment with Inositol 2gm/bid; Active Treatment with Inositol 3gm/ bid
Primary purpose: TREATMENT

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

Detailed description: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Change in total testosterone
timeFrame: baseline and 3 months
Secondary outcomes:
measure: Change in SHBG
timeFrame: baseline and 3 months
measure: Change in Free Androgen Index (FAI)
timeFrame: baseline and 3 months
measure: Change in area under the curve (AUC) of glucose
timeFrame: baseline and 3 months
measure: Change in fasting insulin
timeFrame: baseline and 3 months
Other outcomes:
Locations:
city: Hershey
country: United States
facility: Penn State College of Medicine, Penn State Milton S. Hershey Medical Center
state: Pennsylvania
city: Philadelphia
country: United States
facility: University of Pennsylvania
state: Pennsylvania
Study officials:
affiliation: Penn State College of Medicine, Hershey Medical Center
name: Richard S. Legro, M.D.
role: PRINCIPAL_INVESTIGATOR
References: