Polycystic Ovary SyndromeNCT04645745
Myo-inositol, Alpha-Lactalbumin and Folic Acid Treatment in PCOS
A study testing myo-inositol, alpha-lactalbumin, folic acid in people with Polycystic Ovary Syndrome, run by AGUNCO Obstetrics and Gynecology Centre at 2 sites in 2 countries.
Trial summary
The main aim of this study is to evaluate the effect of myo-inositol and alpha-lactalbumin treatment on HOMA-index improvement in two different groups of women, belonging to the Mexican and Italian population, both affected by Polycystic Ovary Syndrome. Read more about this study
- Who is it for?
- Ages 18 to 40 years, women only
- Conditions the study is for
- Polycystic Ovary Syndrome
- What is being tested?
- myo-inositol, alpha-lactalbumin, folic acid
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 2 sitesin 2 countries
- Study dates
- 15 Jun 2019to 28 Feb 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- PCOS diagnosis based on the Rotterdam ESHRE-ASRM consensus workshop group1.
- Presence of Insulin resistance diagnosed by HOMA-Index
- Patients belonging to the Mexican population
- Patients belonging to the Italian population
Who cannot join
- BMI ≥ 30
- Other conditions causing ovulatory disorders and/or androgens hyper production such as: hyperprolactinemia, hypothyroidism, adrenal hyperplasia and Cushing syndrome
- Hormonal and/or pharmacological treatments in the previous 3 months that could interfere with ovulation
- Drastic changes in diet and physical activity
- Treatment with products containing inositols in the previous 3 months
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
About this study
Official title: Effects of Myo-inositol, Alpha-Lactalbumin and Folic Acid Treatment in PCOS Women of Mexico and Italy
The main aim of this study is to evaluate the effect of myo-inositol and alpha-lactalbumin treatment on HOMA-index improvement in two different groups of women, belonging to the Mexican and Italian population, both affected by Polycystic Ovary Syndrome.
Read the detailed description
This is an open-label clinical trial aimed at evaluating and comparing the effect of myo-inositol and alpha-lactalbumin treatment on HOMA-index improvement in two different groups of PCOS patients from the Mexican and Italian population. The addition of alpha-lactalbumin helps to increase the intestinal absorption of myo-inositol and consequently improve its effect. The scientific evidence so far available shows that these two groups of PCOS women have a different genetic, nutritional, and behavioural profile. Important factors are body mass index and insulin resistance, both increased in the Mexican women, although among them PCOS prevalence is not higher compared to many other populations. Therefore, the focus of this study is to check the effects of the combined administration of myo-inositol and alpha-lactalbumin for six months (with a control at three months) e to compare these effects between the two groups of patients, monitoring several hormonal parameters connected to the menstrual cycle regularization.
- Conditions
- Polycystic Ovary Syndrome
- Being tested
- myo-inositol, alpha-lactalbumin, folic acid
- Keywords
- Myo-inositol, alpha-lactalbumin, HOMA-index, ovulation, hyperandrogenism
- Medical subject headings
- Polycystic Ovary Syndrome, Hyperandrogenism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
myo-inositol, alpha-lactalbumin, folic acidDietary supplement
Evaluating the improvement vs the baseline after three and six months of treatment
| Study group | Role | What they receive |
|---|---|---|
| myo-inositol plus alpha-lactalbumin | Experimental | Patients were treated with 2 g myo-inositol, 50 mg alpha-LA and 200 mcg of Folic Acid twice a day for 6 months. Controls were the same patients at baseline (t0) Receives: Dietary Supplement: myo-inositol, alpha-lactalbumin, folic acid |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of Myo-inositol and alpha-lactalbumin treatment on HOMA-index
monitoring glucose and insulin levels in blood
Measured: three and six months
Secondary outcomes (2)
Evaluation of Myo-inositol and alpha-lactalbumin treatment on ovulation
dosage of Progesterone, LH, FSH.
Measured: three and six months
Evaluation of Myo-inositol and alpha-lactalbumin treatment on hyperandrogenism
dosage of Total Testosterone, Free Testosterone, Androstenedione.
Measured: three and six months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Nov 2020
- Study start15 Jun 2019
- Primary completion31 Jan 2020
- Study completion28 Feb 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Polycystic Ovary SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- AGUNCO Obstetrics and Gynecology Centre
- Sponsor type
- University, hospital or other
- Collaborators
- Hospital Juarez de Mexico
- Responsible party
- Principal investigator, Unfer Vittorio, AGUNCO Obstetrics and Gynecology Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04645745
- Sponsor's protocol ID
- UVittorio
- Status last verified
- Jan 2021
- First submitted
- 23 Jul 2020
- Last updated
- 14 Jan 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Myo-inositol, Alpha-Lactalbumin and Folic Acid Treatment in PCOS Women of Mexico and Italy
- ClinicalTrials.gov ID
- NCT04645745
- Acronym / sponsor ID
- UVittorio
- Conditions
- Polycystic Ovary Syndrome
- Keywords
- Myo-inositol, alpha-lactalbumin, HOMA-index, ovulation, hyperandrogenism
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- AGUNCO Obstetrics and Gynecology CentreUniversity, hospital or other
- Collaborators
- Hospital Juarez de Mexico
- Study start
- 15 Jun 2019 (actual)
- Primary completion
- 31 Jan 2020 (actual)
- Study completion
- 28 Feb 2020 (actual)
- First posted
- 27 Nov 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The main aim of this study is to evaluate the effect of myo-inositol and alpha-lactalbumin treatment on HOMA-index improvement in two different groups of women, belonging to the Mexican and Italian population, both affected by Polycystic Ovary Syndrome.
Detailed description
This is an open-label clinical trial aimed at evaluating and comparing the effect of myo-inositol and alpha-lactalbumin treatment on HOMA-index improvement in two different groups of PCOS patients from the Mexican and Italian population. The addition of alpha-lactalbumin helps to increase the intestinal absorption of myo-inositol and consequently improve its effect. The scientific evidence so far available shows that these two groups of PCOS women have a different genetic, nutritional, and behavioural profile. Important factors are body mass index and insulin resistance, both increased in the Mexican women, although among them PCOS prevalence is not higher compared to many other populations. Therefore, the focus of this study is to check the effects of the combined administration of myo-inositol and alpha-lactalbumin for six months (with a control at three months) e to compare these effects between the two groups of patients, monitoring several hormonal parameters connected to the menstrual cycle regularization.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| myo-inositol plus alpha-lactalbumin | Experimental | Dietary Supplement: myo-inositol, alpha-lactalbumin, folic acidPatients were treated with 2 g myo-inositol, 50 mg alpha-LA and 200 mcg of Folic Acid twice a day for 6 months. Controls were the same patients at baseline (t0) |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- PCOS diagnosis based on the Rotterdam ESHRE-ASRM consensus workshop group1.
- Presence of Insulin resistance diagnosed by HOMA-Index
- Patients belonging to the Mexican population
- Patients belonging to the Italian population
Key exclusion criteria (5 listed)
- BMI ≥ 30
- Other conditions causing ovulatory disorders and/or androgens hyper production such as: hyperprolactinemia, hypothyroidism, adrenal hyperplasia and Cushing syndrome
- Hormonal and/or pharmacological treatments in the previous 3 months that could interfere with ovulation
- Drastic changes in diet and physical activity
- Treatment with products containing inositols in the previous 3 months
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| myo-inositol, alpha-lactalbumin, folic acidEvaluating the improvement vs the baseline after three and six months of treatment | Dietary supplement | myo-inositol plus alpha-lactalbumin |
Primary outcome
Evaluation of Myo-inositol and alpha-lactalbumin treatment on HOMA-index
Time frame: three and six months
monitoring glucose and insulin levels in blood
2 secondary outcomes
Evaluation of Myo-inositol and alpha-lactalbumin treatment on ovulation
Time frame: three and six months
Evaluation of Myo-inositol and alpha-lactalbumin treatment on hyperandrogenism
Time frame: three and six months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jan 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing myo-inositol, alpha-lactalbumin, folic acid in people with Polycystic Ovary Syndrome, run by AGUNCO Obstetrics and Gynecology Centre at 2 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Italy, Mexico. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluation of Myo-inositol and alpha-lactalbumin treatment on HOMA-index (time frame: three and six months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jan 2021.