Health StatusNCT03429231
Observational Study to Evaluate the Quality of Life of Healthy Postmenopausal Women Who Take Coenzyme Q-Ubiquinol
An observational study of Health Status, run by Dr. Santiago Palacios at 1 site in Spain.
Trial summary
Observational study about quality of life in postmenopausal women taking coenzyme Q compared to another group of women of the same age who do not take it Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Health Status
- What is being tested?
- Coenzima Q - QubiquinolCoenzyme Q - Qubiquinol
- Type of treatment
- Pill or oral medicine
- How many people
- 40 participants
- Where
- 1 siteSpain
- Study dates
- 23 Nov 2017to 15 Apr 2018
- Phase
- Observational
- 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 Any age
- Child, Adult, Older adult
Study population: Healthy postmenopausal woman between 45 and 65 years
Who may be able to join
- Postmenopausal woman between 45 and 65 years old
- Woman who is taking coenzyme Q-Ubiquinol and who will continue taking at least the next 3 months
- Woman not taking Coenzyme Q-Ubiquinol and not going to take it in the next 3 months
- Exclusión Criteria:
- Patients with severe mental illness.
- Suspicion or abuse of alcohol or other drugs during the 12 months prior to the selection
- Any other consideration or finding that, in the opinion of the investigator, considers the non-participation of the subject in the study.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Observational Study With Food Product to Evaluate the Quality of Life of Healthy Postmenopausal Women Who Take Coenzyme Q-Ubiquinol, Compared With Another Group of the Same Age That Does Not Take coenzymeQ-Ubiquinol
Observational study about quality of life in postmenopausal women taking coenzyme Q compared to another group of women of the same age who do not take it
Read the detailed description
Observational study to evaluate the subjective assessment performed by healthy postmenopausal women who are taking coenzyme Q for 3 months, compared with other groups of the same characteristics that do not take it
- Conditions
- Health Status
- Being tested
- Coenzima Q - QubiquinolCoenzyme Q - Qubiquinol
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Coenzima Q - QubiquinolCoenzyme Q - QubiquinolDietary supplement
Patients in the active group will take one tablet a day orally
| Study group | Role | What they receive |
|---|---|---|
| Active Group | Women who are taking coenzyme Q and who will continue taking it for 3 months Receives: Dietary Supplement: Coenzima Q - QubiquinolCoenzyme Q - Qubiquinol | |
| Control Group | Women who are not taking coenzyme Q and who will not take it in the next 3 months |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Baseline Quality of Life at 3 months
To evaluate the quality of life in healthy postmenopausal women who are taking Coenzyme Q-Ubiquinol for 3 months in comparison with another group that does not take them. The Cervantes Health-Related Quality of Life scale for menopause will be used for this outcome. In that scale next to the 0 and the 5 there are words that describe two opposite answers to the question. Between the 0 and the 5 there are also four boxes numbered 1 to 4. The participants should answer the questions by checking the box that best represents what they think and feel. In other words, they should check 5 if they are completely agree and 0 they are completely disagree. If they are not completely agree or disagree, they should check the boxes in between
Measured: Baseline and 3 months
Secondary outcomes (3)
Change from Baseline General Health at 3 months
Health Scale Euroqol EQ-5D will be used for this outcome
Measured: Baseline and 3 months
Change from Baseline Mood at three months
An analogic scale will be used for this outcome in wich 0 points is the best mood and 10 points is worst mood
Measured: Baseline and 3 months
Change from Baseline Cramps at three months
To assess changes in cramps in patients who had them, a general questionnaire about Cramps will be used to assess mainly the intensity and frequency of crambs. Regarding the intensity 0 is the lower pain and 10 is the worst pain
Measured: Baseline and 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Feb 2018
- Study start23 Nov 2017
- Primary completion31 Mar 2018
- Study completion15 Apr 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Health StatusStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dr. Santiago Palacios
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Dr. Santiago Palacios, Instituto Palacios
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03429231
- Sponsor's protocol ID
- QUbiquinol17
- Status last verified
- May 2018
- First submitted
- 16 Jan 2018
- Last updated
- 11 May 2018
- 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 11 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Observational Study With Food Product to Evaluate the Quality of Life of Healthy Postmenopausal Women Who Take Coenzyme Q-Ubiquinol, Compared With Another Group of the Same Age That Does Not Take coenzymeQ-Ubiquinol
- ClinicalTrials.gov ID
- NCT03429231
- Acronym / sponsor ID
- QUbiquinol17
- Conditions
- Health Status
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Dr. Santiago PalaciosUniversity, hospital or other
- Study start
- 23 Nov 2017 (actual)
- Primary completion
- 31 Mar 2018 (actual)
- Study completion
- 15 Apr 2018 (actual)
- First posted
- 12 Feb 2018 (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.
Observational study about quality of life in postmenopausal women taking coenzyme Q compared to another group of women of the same age who do not take it
Detailed description
Observational study to evaluate the subjective assessment performed by healthy postmenopausal women who are taking coenzyme Q for 3 months, compared with other groups of the same characteristics that do not take it
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Active Group | – | Dietary Supplement: Coenzima Q - QubiquinolCoenzyme Q - QubiquinolWomen who are taking coenzyme Q and who will continue taking it for 3 months |
| Control Group | – | –Women who are not taking coenzyme Q and who will not take it in the next 3 months |
Who may qualify
- Age groups
- Child, Adult, Older adult
- Study population
- Healthy postmenopausal woman between 45 and 65 years
Key inclusion criteria (7 listed)
- Postmenopausal woman between 45 and 65 years old
- Woman who is taking coenzyme Q-Ubiquinol and who will continue taking at least the next 3 months
- Woman not taking Coenzyme Q-Ubiquinol and not going to take it in the next 3 months
- Patients with severe mental illness.
- Suspicion or abuse of alcohol or other drugs during the 12 months prior to the selection
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| Coenzima Q - QubiquinolCoenzyme Q - QubiquinolPatients in the active group will take one tablet a day orally | Dietary supplement | Active Group |
Primary outcome
Change from Baseline Quality of Life at 3 months
Time frame: Baseline and 3 months
To evaluate the quality of life in healthy postmenopausal women who are taking Coenzyme Q-Ubiquinol for 3 months in comparison with another group that does not take them. The Cervantes Health-Related Quality of Life scale for menopause will be used for this outcome. In that scale next to the 0 and the 5 there are words that describe two opposite answers to the question. Between the 0 and the 5 there are also four boxes numbered 1 to 4. The participants should answer the questions by checking the box that best represents what they think and feel. In other words, they should check 5 if they are completely agree and 0 they are completely disagree. If they are not completely agree or disagree, they should check the boxes in between
3 secondary outcomes
Change from Baseline General Health at 3 months
Time frame: Baseline and 3 months
Change from Baseline Mood at three months
Time frame: Baseline and 3 months
Change from Baseline Cramps at three months
Time frame: Baseline and 3 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 11 May 2018.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Health Status, run by Dr. Santiago Palacios at 1 site in Spain.
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 7 inclusion and 0 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 11 May 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. 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?
Change from Baseline Quality of Life at 3 months (time frame: Baseline and 3 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 11 May 2018.