Thursday, April 18, 2024 4/18/2024

Inositol Supplementation to Treat Reproductive and Metabolic Dysfunction in Polycystic Ovary Syndrome: A Double Blind RCT (INSUPP-PCOS)

Award Number: R01AT009484
ORGANIZATION: CENTER FOR DRUG EVALUATION AND RESEARCH, NIH
OPDIV: NIH
AWARD CLASS: DISCRETIONARY
AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)

Group Awards By Issue Date FY or Funding FY:

View Award Abstract

The revised project summary/abstract: Polycystic ovary syndrome (PCOS) is the most common endocrinopathy among women. It is a heterogeneous syndrome with reproductive dysfunction of chronic anovulation and hyperandrogenism, as well as metabolic dysfunction: insulin resistance, glucose intolerance and metabolic syndrome. One such medication that may improve both aspects of PCOS is inositol and it is available throughout the world as a dietary supplement. More specifically we will study a combination of isomers, d-chiro and myo-inositol. The combination is thought to improve insulin (and gonadotropin) signaling by restoring an imbalance in inositolglycans which are second messengers in cell surface signaling. We propose here the first adequately powered and designed clinical trial to test prospectively the effects of inositol supplementation in a dose ranging double blind randomized controlled trial, (the INSUPP- PCOS study) 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. We bring to this study a proven and established team of multi-disciplinary researchers who have successfully conducted multiple related trials. Our trial is highly innovative and significant, as we are studying a widely used supplement that may have a broad indication across all phases of the reproductive lifespan of a woman with PCOS. Further by registering the trial, preparing a written protocol and manual of operations and procedures and by following CONSORT guidelines we will be establishing a rigorous bulwark to allow for replication of our trial.


Issue Date FY	Funding FY	Legal Entity Name	Legal Entity Address	Legal Entity City	Legal Entity State	Legal Entity Zip Code	Legal Entity COUNTY	Legal Entity COUNTRY	Assistance Listing	Award Code	Budget Year	Action Date	Action Type	Action Amount

Issue Date FY: 2023 ( Subtotal = $0 )
2023	2022	PENNSYLVANIA STATE UNIVERSITY	500 UNIVERSITY DRIVE	HERSHEY	PA	17033	DAUPHIN	USA	Research and Training in Complementary and Integrative Health	001	4	6/20/2023	NON-COMPETING CONTINUATION	$0
2023	2022	PENNSYLVANIA STATE UNIVERSITY	500 UNIVERSITY DRIVE	HERSHEY	PA	17033	DAUPHIN	USA	Research and Training in Complementary and Integrative Health	002	4	9/5/2023	NON-COMPETING CONTINUATION	$0
2023	2019	PENNSYLVANIA STATE UNIVERSITY, THE	500 UNIVERSITY AVE RM C1607	HERSHEY	PA	17033	DAUPHIN	USA	Research and Training in Complementary and Integrative Health	000	2	11/29/2022	NON-COMPETING CONTINUATION	$0
														Subtotal = $0

Issue Date FY: 2022 ( Subtotal = $527,034 )
2022	2022	PENNSYLVANIA STATE UNIVERSITY, THE	500 UNIVERSITY AVE RM C1607	HERSHEY	PA	17033	DAUPHIN	USA	Research and Training in Complementary and Integrative Health	000	4	9/19/2022	NON-COMPETING CONTINUATION	$527,034
														Subtotal = $527,034

Issue Date FY: 2021 ( Subtotal = $527,033 )
2021	2021	PENNSYLVANIA STATE UNIVERSITY, THE	500 UNIVERSITY AVE RM C1607	HERSHEY	PA	17033	DAUPHIN	USA	Research and Training in Complementary and Integrative Health	001	3	8/26/2021	NON-COMPETING CONTINUATION	$527,033
2021	2019	PENNSYLVANIA STATE UNIVERSITY, THE	500 UNIVERSITY AVE RM C1607	HERSHEY	PA	17033	DAUPHIN	USA	Research and Training in Complementary and Integrative Health	000	2	1/28/2021	NON-COMPETING CONTINUATION	$0
														Subtotal = $527,033

Issue Date FY: 2020 ( Subtotal = $0 )
2020	2019	PENNSYLVANIA STATE UNIVERSITY, THE	500 UNIVERSITY DR C1607	HERSHEY	PA	17033	DAUPHIN	USA	Research and Training in Complementary and Integrative Health	001	2	8/21/2020	NON-COMPETING CONTINUATION	$0
2020	2019	PENNSYLVANIA STATE UNIVERSITY, THE	500 UNIVERSITY DR C1607	HERSHEY	PA	17033	DAUPHIN	USA	Research and Training in Complementary and Integrative Health	000	2	1/24/2020	NON-COMPETING CONTINUATION	$0
														Subtotal = $0

Issue Date FY: 2019 ( Subtotal = $527,035 )
2019	2019	PENNSYLVANIA STATE UNIVERSITY, THE	500 UNIVERSITY DR C1607	HERSHEY	PA	17033	DAUPHIN	USA	Research and Training in Complementary and Integrative Health	001	2	8/30/2019	NON-COMPETING CONTINUATION	$527,035
2019	2018	PENNSYLVANIA STATE UNIVERSITY, THE	500 UNIVERSITY DR C1607	HERSHEY	PA	17033	DAUPHIN	USA	Research and Training in Complementary and Integrative Health	000	1	8/30/2019	NEW	$0
														Subtotal = $527,035

Issue Date FY: 2018 ( Subtotal = $539,301 )
2018	2018	PENNSYLVANIA STATE UNIVERSITY, THE	500 UNIVERSITY DR C1607	HERSHEY	PA	17033	DAUPHIN	USA	Research and Training in Complementary and Integrative Health	000	1	8/27/2018	NEW	$539,301
														Subtotal = $539,301

Grand Total All Awards = $2,120,403

Top

All Categories

About

Search

Reports

Data Submission

Award Information

Inositol Supplementation to Treat Reproductive and Metabolic Dysfunction in Polycystic Ovary Syndrome: A Double Blind RCT (INSUPP-PCOS)

Award Number: R01AT009484

ORGANIZATION: CENTER FOR DRUG EVALUATION AND RESEARCH, NIH

OPDIV: NIH

AWARD CLASS: DISCRETIONARY

AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)

Federal Websites

Department of Health & Human Services

HHS Operating Divisions

HHS Staff Divisions

Download A Document Viewer