Condition category
Nutritional, Metabolic, Endocrine
Date applied
23/09/2019
Date assigned
02/10/2019
Last edited
03/04/2020
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting
Publication status
Results

Plain English Summary

Background and study aims
Polycystic ovary syndrome (PCOS) is a condition affecting hormone levels in women. Common symptoms include irregular periods, weight gain and excess hair growth. It is currently not known what causes PCOS, but it is associated with high levels of insulin (the hormone that controls sugar levels in the blood) and insulin resistance (where the body does not respond correctly to insulin).
Homocysteine is an amino acid (a component of proteins) that is normally found in the human body, but is increased in many women with PCOS. Increased homocysteine levels are also involved in several other conditions that can be associated with PCOS including cardiovascular disease and infertility. People with high homocysteine levels can be prescribed folic acid to reduce it. However, folic acid only stimulates one pathway to reduce homocysteine levels and needs to be give at high doses, which can cause side effects. This study aims to investigate whether a supplement containing a mixture of vitamins, zinc and other micronutrients that can activate multiple pathways to reduce homocysteine levels is effective in reducing homocysteine levels

Who can participate?
Women aged over 18 years with PCOS

What does the study involve?
Participants will be randomly allocated into one of two groups. One group will receive no treatment. The other group will take the one tablet of the supplement every day for 3 months and will be asked whether they took the tablets as instructed at the end of the 3 months. All women participating in the study have a blood sample taken at the time of enrolment and again at the end of a 3-month period. The blood sample will be used to run tests that are usually performed as part of the standard follow-up of PCOS patients. Only homocysteine level, which is not routinely tested in all PCOS patients, will be an additional test. However it will be tested on the same blood sample used for the other tests and will not cause additional burden on the patient.

What are the possible benefits and risks of participating?
The risk from study participation is minimal because it involves no additional blood-taking and because the supplement in use is considered safe according to the current EU regulations. The supplement contains micronutrients that are already part of a balanced diet at similar amounts. These micronutrients include B vitamins (B2, B3, B6 and B12), folates (in the activated form of methylfolate), betaine, cystine and zinc. None of these micronutrients are known to cause allergies, furthermore the product is certified as lactose-free and gluten-free.
Participants taking the supplement might benefit from improvements in their PCOS symptoms.

Where is the study run from?
Azienda Ospedaliera Universitaria di Perugia (Italy)

When is the study starting and how long is it expected to run for?
March 2017 to December 2018

Who is funding the study?
The University of Perugia (Italy). In addition, the company that makes the Impryl supplement (Parthenogen, Switzerland) has provided the supplement to supply the study.

Who is the main contact?
Professor Sandro Gerli, sandro.gerli@unipg.it

Trial website

Contact information

Type

Public

Primary contact

Prof Sandro Gerli

ORCID ID

http://orcid.org/0000-0003-1082-3062

Contact details

Corso Cavour 172
Perugia
06121
Italy
+39 368434624
sandro.gerli@unipg.it

Additional identifiers

EudraCT number

Nil known

ClinicalTrials.gov number

Nil known

Protocol/serial number

MED40-2016-01

Study information

Scientific title

Micronutrients in support to the one carbon cycle for the modulation of blood fasting homocysteine in PCOS women

Acronym

MIC-PCOS

Study hypothesis

The present study was intended to test the opportunity to achieve a better effective reduction of homocysteine in PCOS women by means of a wider array of the concerned micronutrients supporting all concerned pathways.

Ethics approval

Approved 09/02/2017, Comitato Etico Azienda Sanitarie (CEAS) dell'Umbria (Via della Rivoluzione, 16
06070 Ellera di Corciano, Perugia, Umbria, Italy; +39 075 5170199; segreteria@ceasumbria.it), ref: 2846/16

Study design

Prospective, single-centre, randomized, parallel group, open label, controlled versus no treatment clinical study.

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a participant information sheet.

Condition

Polycystic ovary syndrome

Intervention

Randomization according to a computer generated list for treatment with the test product or no treatment with a 2:1 ratio to receive the supplement or no treatment for 3 months.
The GMP-manufactured dietary supplement (Impryl, Parthenogen, Switzerland) is in the form of a tablet weighing 1.3 g containing the following nutrients: Betaine 200 mg, L-cystine 200 mg, niacin 16 mg, zinc 10 mg, vitamin B6 1.4 mg, riboflavin 1.4 mg, folic acid (as methylfolate) 400 microg, vitamin B12 (methylcobalamin) 2.5 μg. Participants will take one tablet per day.


Intervention type

Supplement

Phase

Drug names

Primary outcome measure

Fasting blood homocysteine measured using chemiluminescence before treatment and at the end of the 3-month follow-up

Secondary outcome measures

1. Anti-Mullerian hormone (AMH) measured using ELISA before treatment and at the end of the 3-month follow-up
2. Testosterone measured using an automated immunoassay system before treatment and at the end of the 3-month follow-up
3. Sex hormone-binding globulins (SHBGs) measured using radioimmunoassay (RIA) before treatment and at the end of the 3-month follow-up
4. Free testosterone index (FTI) was calculated using the testosterone and SHGB data before treatment and at the end of the 3-month follow-up

Overall trial start date

12/03/2017

Overall trial end date

12/12/2018

Reason abandoned (if study stopped)

Eligibility

Participant inclusion criteria

1. Women referred for gynaecological problems and diagnosed as affected by PCOS according to Rotterdam criteria [Hum Reprod 2004]
2. Aged over 18 years

Participant type

Patient

Age group

Adult

Gender

Female

Target number of participants

32

Total final enrolment

32

Participant exclusion criteria

1. Ongoing pregnancy
2. Ongoing pharmacological treatment (oral antidiabetic drugs, insulin, antihypertensives, any hormone)
3. Ongoing systemic or endocrine diseases, including hypertension and thyroid diseases

Recruitment start date

03/06/2017

Recruitment end date

28/10/2018

Locations

Countries of recruitment

Italy

Trial participating centre

Sandro Gerli
Corso Cavour 172
Perugia
06121
Italy

Sponsor information

Organisation

University of Perugia

Sponsor details

Piazza dell'Università 1
Perugia
06121
Italy
(+39) 075 5858174
mauro.bacci@unipg.it

Sponsor type

University/education

Website

Funders

Funder type

University/education

Funder name

Università degli Studi di Perugia

Alternative name(s)

University of Perugia, Universidad degli Studi de Perusa

Funding Body Type

government organisation

Funding Body Subtype

Local government

Location

Italy

Results and Publications

Publication and dissemination plan

Planned publication in a high-impact peer-reviewed journal.

IPD sharing statement:
The datasets generated and/or analysed during this study will be included in the subsequent results publication.

Intention to publish date

01/10/2019

Participant level data

Other

Basic results (scientific)

Publication list

2019 results in https://pubmed.ncbi.nlm.nih.gov/31845191/ (added 03/04/2020)

Publication citations

Additional files

Editorial Notes

03/04/2020: The following changes were made to the trial record: 1. Publication reference added. 2. The total final enrolment was added. 30/09/2019: Trial's existence confirmed by the Azienda Ospedaliera di Perugia [Peugia Hospital Agency] and the Comitato Etico Azienda Sanitarie (CEAS) dell'Umbria [Umbria Health Authority Ethics Committee].