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Inositol Supplementation to Treat PCOS (INSUPP-PCOS) (INSUPP-PCOS)

Primary Purpose

Polycystic Ovary Syndrome, Anovulation, Hyperandrogenism

Status
Recruiting
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Placebo
Inositol
Sponsored by
Milton S. Hershey Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Polycystic Ovary Syndrome focused on measuring Polycystic Ovary Syndrome, Anovulation, Hyperandrogenism, Insulin Resistance, Glucose Intolerance, Metabolic Complication

Eligibility Criteria

18 Years - 45 Years (Adult)FemaleDoes not accept healthy volunteers

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.

Sites / Locations

  • Penn State College of Medicine, Penn State Milton S. Hershey Medical CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Placebo Comparator

Experimental

Experimental

Experimental

Arm Label

Placebo Treatment bid

Active Treatment with Inositol 1gm/bid

Active Treatment with Inositol 2 gm/bid

Active Treatment with Inositol 3 gm/bid

Arm Description

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.

Outcomes

Primary Outcome Measures

Change in total testosterone
Serum total testosterone levels

Secondary Outcome Measures

Change in SHBG
SHBG levels
Change in Free Androgen Index (FAI)
FAI levels
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.
Change in fasting insulin
Fasting insulin levels

Full Information

First Posted
March 4, 2019
Last Updated
October 10, 2023
Sponsor
Milton S. Hershey Medical Center
Collaborators
National Center for Complementary and Integrative Health (NCCIH)
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1. Study Identification

Unique Protocol Identification Number
NCT03864068
Brief Title
Inositol Supplementation to Treat PCOS (INSUPP-PCOS)
Acronym
INSUPP-PCOS
Official Title
Inositol Supplementation to Treat Polycystic Ovary Syndrome: A Double Blind Dose Ranging RCT (INSUPP-PCOS)
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
January 24, 2020 (Actual)
Primary Completion Date
August 31, 2024 (Anticipated)
Study Completion Date
August 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Milton S. Hershey Medical Center
Collaborators
National Center for Complementary and Integrative Health (NCCIH)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Polycystic Ovary Syndrome, Anovulation, Hyperandrogenism, Insulin Resistance, Glucose Intolerance, Metabolic Complication
Keywords
Polycystic Ovary Syndrome, Anovulation, Hyperandrogenism, Insulin Resistance, Glucose Intolerance, Metabolic Complication

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Model Description
Placebo Group; Active Treatment with Inositol 1gm/bid; Active Treatment with Inositol 2gm/bid; Active Treatment with Inositol 3gm/ bid
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
128 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Placebo Treatment bid
Arm Type
Placebo Comparator
Arm Description
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.
Arm Title
Active Treatment with Inositol 1gm/bid
Arm Type
Experimental
Arm Description
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.
Arm Title
Active Treatment with Inositol 2 gm/bid
Arm Type
Experimental
Arm Description
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.
Arm Title
Active Treatment with Inositol 3 gm/bid
Arm Type
Experimental
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Placebo
Other Intervention Name(s)
maltodextrin and inulin
Intervention Description
Placebo
Intervention Type
Drug
Intervention Name(s)
Inositol
Intervention Description
1gm/bid, 2gm/bid or 3gm/bid of Inositol powder
Primary Outcome Measure Information:
Title
Change in total testosterone
Description
Serum total testosterone levels
Time Frame
baseline and 3 months
Secondary Outcome Measure Information:
Title
Change in SHBG
Description
SHBG levels
Time Frame
baseline and 3 months
Title
Change in Free Androgen Index (FAI)
Description
FAI levels
Time Frame
baseline and 3 months
Title
Change in area under the curve (AUC) of glucose
Description
AUC of a 2-hour 75g glucose tolerance test, which measures glucose at 0, 30, 60, 90, and 120 minutes.
Time Frame
baseline and 3 months
Title
Change in fasting insulin
Description
Fasting insulin levels
Time Frame
baseline and 3 months

10. Eligibility

Sex
Female
Gender Based
Yes
Gender Eligibility Description
PCOS is a disorder that only affects women and therefore men are not eligible to participate in this study.
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Amyee McMonagle, BSN
Phone
717-531-4484
Email
amcmonagle@pennstatehealth.psu.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Sandra Eyer
Phone
717-531-6208
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Richard S. Legro, M.D.
Organizational Affiliation
Penn State College of Medicine, Hershey Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Penn State College of Medicine, Penn State Milton S. Hershey Medical Center
City
Hershey
State/Province
Pennsylvania
ZIP/Postal Code
17033
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Richard S. Legro, M.D.
Phone
717-531-8478
Email
rsl1@psu.edu
First Name & Middle Initial & Last Name & Degree
Amyee McMonagle, BSN
Phone
717-531-4484
Email
amcmonagle@pennstatehealth.psu.edu
First Name & Middle Initial & Last Name & Degree
Richard S Legro, M.D.

12. IPD Sharing Statement

Learn more about this trial

Inositol Supplementation to Treat PCOS (INSUPP-PCOS)

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