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

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ClinicalTrials.gov Identifier: NCT03864068
Recruitment Status : Not yet recruiting
First Posted : March 6, 2019
Last Update Posted : July 17, 2019
Sponsor:
Collaborator:
National Center for Complementary and Integrative Health (NCCIH)
Information provided by (Responsible Party):
Richard S. Legro, M.D., Milton S. Hershey Medical Center

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

Condition or disease Intervention/treatment Phase
Polycystic Ovary Syndrome Anovulation Hyperandrogenism Insulin Resistance Glucose Intolerance Metabolic Complication Other: Placebo Drug: Inositol powder Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 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/ 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)
Estimated Study Start Date : September 1, 2019
Estimated Primary Completion Date : August 31, 2022
Estimated Study Completion Date : August 31, 2023


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




Primary Outcome Measures :
  1. Change in total testosterone [ Time Frame: baseline and 3 months ]
    Serum total testosterone levels


Secondary Outcome Measures :
  1. Change in SHBG [ Time Frame: baseline and 3 months ]
    SHBG levels

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

  3. Change in area under the curve (AUC) of glucose [ Time Frame: 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 [ Time Frame: baseline and 3 months ]
    Fasting insulin levels



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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   PCOS is a disorder that only affects women and therefore men are not eligible to participate in this study.
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03864068


Contacts
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Contact: Heidi Watts, BSN 717-531-6272 hwatts@pennstatehealth.psu.edu
Contact: Sandra Eyer 717-531-6208

Locations
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United States, Pennsylvania
Penn State College of Medicine, Penn State Milton S. Hershey Medical Center Not yet recruiting
Hershey, Pennsylvania, United States, 17033
Contact: Richard S. Legro, M.D.    717-531-8478    rsl1@psu.edu   
Contact: Heidi Watts, BSN    717-531-6272    hwatts@pennstatehealth.psu.edu   
Principal Investigator: Richard S Legro, M.D.         
Sponsors and Collaborators
Milton S. Hershey Medical Center
National Center for Complementary and Integrative Health (NCCIH)
Investigators
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Principal Investigator: Richard S. Legro, M.D. Penn State College of Medicine, Hershey Medical Center

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Responsible Party: Richard S. Legro, M.D., Chair, Obstetrics and Gynecology, Milton S. Hershey Medical Center
ClinicalTrials.gov Identifier: NCT03864068     History of Changes
Other Study ID Numbers: Study00010252
1R01AT009484-01A1 ( U.S. NIH Grant/Contract )
First Posted: March 6, 2019    Key Record Dates
Last Update Posted: July 17, 2019
Last Verified: July 2019

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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., Milton S. Hershey Medical Center:
Polycystic Ovary Syndrome
Anovulation
Hyperandrogenism
Insulin Resistance
Glucose Intolerance
Metabolic Complication
Additional relevant MeSH terms:
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Polycystic Ovary Syndrome
Hyperandrogenism
Anovulation
Insulin Resistance
Glucose Intolerance
Syndrome
Disease
Pathologic Processes
Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases
Ovarian Cysts
Cysts
Neoplasms
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Gonadal Disorders
Endocrine System Diseases
Hyperglycemia
46, XX Disorders of Sex Development
Disorders of Sex Development
Urogenital Abnormalities
Adrenogenital Syndrome
Congenital Abnormalities
Inositol
Vitamin B Complex
Vitamins
Micronutrients
Nutrients