Evaluation of D-chiro-inositol Treatments | NCT05448378

Studies
Evaluation of D-chiro-inositol Treatments

NCT05448378

Sponsor

Lo.Li.Pharma s.r.l

Status

Completed

Last Update Posted

Sep 19, 2022Actual

Enrollment

10Actual

Phase

Not Applicable

Conditions

Inositol
Testosterone
Insulin
Ovulation
Asprosin

Interventions

D-chiro-inositol

Countries

Italy

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2022

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 4, 2022Actual

Primary Completion Date

Aug 30, 2022Actual

Completion Date

Sep 16, 2022Actual

First Submitted Date

Jul 4, 2022

First Submission Date that Met QC Criteria

Jul 4, 2022

First Posted Date

Jul 7, 2022Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 16, 2022

Last Update Posted Date

Sep 19, 2022Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

Healthy women will take tablets containing 600 mg D-chiro-inositol twice per day for one month. We will evaluate metabolic and hormonal.parameters, as insulienmia, glycemia, estradiol, testosterone.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

10Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
D-chiro-inositol	Experimental	Patients will take D-chiro-inositol. We will make two blood sampling, at the baseline and after one-month treatment	Dietary Supplement: D-chiro-inositol

Interventions

Name	Type	Description	Arm Group Labels	Other Names
D-chiro-inositol	Dietary Supplement	D-chiro-inositol 600 mg twice per day on an empty stomach for one month	D-chiro-inositol

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Testosterone	Serum values of testosterone	30 days

Secondary Outcomes

Measure	Description	Time Frame
BMI	body-mass index	30 days
Glycemia	Serum values of glucose	30 days

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Good state of health;
Regular menstrual cycle.

Exclusion Criteria:

pregnancy;
delivery in the previous 6 months;
currently breastfeeding;
menopause;
alcohol or drug abuse;
insulin resistance defined as HOMA-IR index greater than or equal to 2.5;
other medical morbidities, such as hypertension, PCOS, or diabetes;
oligomenorrhea or amenorrhea;
current treatment with corticosteroids or hormones (oral contraceptives, estrogensic, progestogensin);
use of GnRH analogues, SERMs, or SPRMs within the previous 6 months.

Accepts Healthy Volunteers

Yes

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

50 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
ASL Civitavecchia		Rome	Lazio	00053	Italy
ALMA RES

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D007333	Insulin Resistance
D054119	Arachnodactyly

Ancestor Terms

ID	Term
D006946	Hyperinsulinism
D044882	Glucose Metabolism Disorders
D008659	Metabolic Diseases
D009750	Nutritional and Metabolic Diseases

Browse Leaves

Not provided

Browse Branches

Not provided