Inositol Supplementation to Treat PCOS (INSUPP-PCOS)

Sponsor
Milton S. Hershey Medical Center (Other)
Overall Status
Recruiting
CT.gov ID
NCT03864068
Collaborator
National Center for Complementary and Integrative Health (NCCIH) (NIH)
128
1
4
47.2
2.7

Study Details

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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
128 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
Placebo Group; Active Treatment with Inositol 1gm/bid; Active Treatment with Inositol 2gm/bid; Active Treatment with Inositol 3gm/ bidPlacebo Group; Active Treatment with Inositol 1gm/bid; Active Treatment with Inositol 2gm/bid; Active Treatment with Inositol 3gm/ bid
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
Inositol Supplementation to Treat Polycystic Ovary Syndrome: A Double Blind Dose Ranging RCT (INSUPP-PCOS)
Actual Study Start Date :
Jan 24, 2020
Anticipated Primary Completion Date :
Dec 31, 2023
Anticipated Study Completion Date :
Dec 31, 2023

Arms and Interventions

Arm Intervention/Treatment
Placebo Comparator: Placebo Treatment bid

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.

Other: Placebo
Placebo
Other Names:
  • maltodextrin and inulin
  • Experimental: Active Treatment with Inositol 1gm/bid

    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.

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

    Experimental: Active Treatment with Inositol 2 gm/bid

    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.

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

    Experimental: Active Treatment with Inositol 3 gm/bid

    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.

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

    Outcome Measures

    Primary Outcome Measures

    1. Change in total testosterone [baseline and 3 months]

      Serum total testosterone levels

    Secondary Outcome Measures

    1. Change in SHBG [baseline and 3 months]

      SHBG levels

    2. Change in Free Androgen Index (FAI) [baseline and 3 months]

      FAI levels

    3. Change in area under the curve (AUC) of glucose [baseline and 3 months]

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

    4. Change in fasting insulin [baseline and 3 months]

      Fasting insulin levels

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 45 Years
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    No
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Penn State College of Medicine, Penn State Milton S. Hershey Medical Center Hershey Pennsylvania United States 17033

    Sponsors and Collaborators

    • Milton S. Hershey Medical Center
    • National Center for Complementary and Integrative Health (NCCIH)

    Investigators

    • Principal Investigator: Richard S. Legro, M.D., Penn State College of Medicine, Hershey Medical Center

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Richard S. Legro, M.D., Chair, Obstetrics and Gynecology, Milton S. Hershey Medical Center
    ClinicalTrials.gov Identifier:
    NCT03864068
    Other Study ID Numbers:
    • Study00010252
    • 1R01AT009484-01A1
    First Posted:
    Mar 6, 2019
    Last Update Posted:
    Jul 20, 2022
    Last Verified:
    Jul 1, 2022
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Richard S. Legro, M.D., Chair, Obstetrics and Gynecology, Milton S. Hershey Medical Center
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Jul 20, 2022