Inositol Supplementation to Treat PCOS (INSUPP-PCOS)

Insulin Resistance Clinical Trial

— INSUPP-PCOS  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03864068
• Other study ID #: Study00010252
• Secondary ID: 1R01AT009484-01A
• Status: Recruiting
• Phase: Phase 2
• Start date: January 24, 2020
• Est. completion date: August 31, 2024

Study information

• Verified date: February 2024
• Source: Milton S. Hershey Medical Center
• Contact: Amyee McMonagle, BSN
• Phone: 717-531-4484
• Email: amcmonagle[@]pennstatehealth.psu.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 128
• Est. completion date: August 31, 2024
• Est. primary completion date: August 31, 2024
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

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.

Related Conditions & MeSH terms

• Anovulation
• Glucose Intolerance
• Hyperandrogenism
• Insulin Resistance
• Metabolic Complication
• Polycystic Ovary Syndrome
• Syndrome

Intervention

Other:
• Placebo
Placebo

Drug:
• Inositol
1gm/bid, 2gm/bid or 3gm/bid of Inositol powder

Locations

Country	Name	City	State
United States	Penn State College of Medicine, Penn State Milton S. Hershey Medical Center	Hershey	Pennsylvania
United States	University of Pennsylvania	Philadelphia	Pennsylvania

Sponsors (2)

Lead Sponsor	Collaborator
Milton S. Hershey Medical Center	National Center for Complementary and Integrative Health (NCCIH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in total testosterone	Serum total testosterone levels	baseline and 3 months
Secondary	Change in SHBG	SHBG levels	baseline and 3 months
Secondary	Change in Free Androgen Index (FAI)	FAI levels	baseline and 3 months
Secondary	Change in area under the curve (AUC) of glucose	AUC of a 2-hour 75g glucose tolerance test, which measures glucose at 0, 30, 60, 90, and 120 minutes.	baseline and 3 months
Secondary	Change in fasting insulin	Fasting insulin levels	baseline and 3 months