Premenstrual SyndromeNCT02809066
Dietary Calcium Intake in Premenstrual Syndrome
A study testing Sufficient dietary calcium intake in premenstrual syndrome in people with Premenstrual Syndrome, run by Eastern Mediterranean University at 1 site in Turkey (Türkiye).
Trial summary
This study was planned and conducted to investigate effect of adequate calcium intake on Premenstrual Syndrome (PMS) symptoms in women with PMS who have inadequate calcium intake. Read more about this study
- Who is it for?
- Ages 20 to 28 years, women only
- Conditions the study is for
- Premenstrual Syndrome
- What is being tested?
- Sufficient dietary calcium intake in premenstrual syndrome
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 31 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- Jan 2015to Jan 2016
- 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 20 to 28 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Women with;
- PMS who have inadequate calcium intake
- Regular menstrual cycle
- Menstrual flow which occurs every 22 to 35 days and last three to eight days
Who cannot join
- Having any of metabolic diseases
- Use oral contraceptive pill
- user vitamins and minerals supplements
- being smoker
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Sufficient Dietary Calcium Intake in Women With Premenstrual Syndrome
This study was planned and conducted to investigate effect of adequate calcium intake on Premenstrual Syndrome (PMS) symptoms in women with PMS who have inadequate calcium intake.
Read the detailed description
This study was planned and conducted to investigate effect of adequate calcium intake on Premenstrual Syndrome (PMS) symptoms in women with PMS who have inadequate calcium intake. Thirty one women, aged between 20-28 years, diagnosed with PMS and suitable for inclusion criteria, were participated in study. Participants were allocated to intervention (n=16) and control (n=15) groups randomly.
- Conditions
- Premenstrual Syndrome
- Being tested
- Sufficient dietary calcium intake in premenstrual syndrome
- Keywords
- premenstrual syndrome, calcium, quality of life
- Medical subject headings
- Premenstrual Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sufficient dietary calcium intake in premenstrual syndromeOther
Intervention group was ensured to take at least 1000 mg calcium from foods, 700-800 mg of it from dairy and dairy products, according to Recommended Dietary Allowances (RDA), for two months. These foods were;
- 50 gr kashkaval cheese,
- 400 ml milk and
- 150 gr yogurt for each day.
| Study group | Role | What they receive |
|---|---|---|
| Interventional group | Experimental | 8-week follow- up with dietary sufficient calcium intake Receives: Other: Sufficient dietary calcium intake in premenstrual syndrome |
| Control group | No intervention | 8-week follow- up with no specific diet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Premenstrual Syndrome Scale (PMSS)
Premenstrual Syndrome Scale (PMSS) was used for symptom assessment at initial and after two menstrual cycles.
Measured: Eight weeks
Secondary outcomes (1)
Change in Quality of life scale Short Form (SF-36)
Measured: Eight weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2016 (estimated)
- Study startJan 2015
- Primary completionNov 2015
- Study completionJan 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Premenstrual 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- Eastern Mediterranean University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Merve YURT, Eastern Mediterranean University
- Investigators
- Merve Yurt, MS, Principal investigator, Eastern Mediterranean University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02809066
- Sponsor's protocol ID
- 2015/10-03
- Status last verified
- Jun 2016
- First submitted
- 16 Jun 2016
- Last updated
- 22 Jun 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 22 Jun 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Sufficient Dietary Calcium Intake in Women With Premenstrual Syndrome
- ClinicalTrials.gov ID
- NCT02809066
- Acronym / sponsor ID
- 2015/10-03
- Conditions
- Premenstrual Syndrome
- Keywords
- premenstrual syndrome, calcium, quality of life
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 31 participants (actual)
- Lead sponsor
- Eastern Mediterranean UniversityUniversity, hospital or other
- Study start
- Jan 2015
- Primary completion
- Nov 2015 (actual)
- Study completion
- Jan 2016 (actual)
- First posted
- 22 Jun 2016 (estimated)
- 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.
This study was planned and conducted to investigate effect of adequate calcium intake on Premenstrual Syndrome (PMS) symptoms in women with PMS who have inadequate calcium intake.
Detailed description
This study was planned and conducted to investigate effect of adequate calcium intake on Premenstrual Syndrome (PMS) symptoms in women with PMS who have inadequate calcium intake. Thirty one women, aged between 20-28 years, diagnosed with PMS and suitable for inclusion criteria, were participated in study. Participants were allocated to intervention (n=16) and control (n=15) groups randomly.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Interventional group | Experimental | Other: Sufficient dietary calcium intake in premenstrual syndrome8-week follow- up with dietary sufficient calcium intake |
| Control group | No intervention | –8-week follow- up with no specific diet |
Who may qualify
- Ages
- 20 to 28 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Women with;
- PMS who have inadequate calcium intake
- Regular menstrual cycle
- Menstrual flow which occurs every 22 to 35 days and last three to eight days
Key exclusion criteria (4 listed)
- Having any of metabolic diseases
- Use oral contraceptive pill
- user vitamins and minerals supplements
- being smoker
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 |
|---|---|---|
| Sufficient dietary calcium intake in premenstrual syndromeIntervention group was ensured to take at least 1000 mg calcium from foods, 700-800 mg of it from dairy and dairy products, according to Recommended Dietary Allowances (RDA), for two months. These foods were; * 50 gr kashkaval cheese, * 400 ml milk and * 150 gr yogurt for each day. | Other | Interventional group |
Primary outcome
Change in Premenstrual Syndrome Scale (PMSS)
Time frame: Eight weeks
Premenstrual Syndrome Scale (PMSS) was used for symptom assessment at initial and after two menstrual cycles.
1 secondary outcome
Change in Quality of life scale Short Form (SF-36)
Time frame: Eight weeks
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 22 Jun 2016.
- Individual participant dataSharing planned: Undecided
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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.
Merve Yurt, MS principal investigator
Eastern Mediterranean University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sufficient dietary calcium intake in premenstrual syndrome in people with Premenstrual Syndrome, run by Eastern Mediterranean University at 1 site in Turkey (Türkiye).
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 4 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 22 Jun 2016. 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 Turkey (Türkiye). 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 in Premenstrual Syndrome Scale (PMSS) (time frame: Eight weeks). 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 22 Jun 2016.