Back to resultsDietary Calcium Intake in Premenstrual Syndrome
Primary Purpose
Premenstrual Syndrome
Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Sufficient dietary calcium intake in premenstrual syndrome
Sponsored by
About this trial
This is an interventional treatment trial for Premenstrual Syndrome focused on measuring premenstrual syndrome, calcium, quality of life
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
- Having any of metabolic diseases
- Use oral contraceptive pill
- user vitamins and minerals supplements
- being smoker
Sites / Locations
- Eastern Mediterranean University
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Interventional group
Control group
Arm Description
8-week follow- up with dietary sufficient calcium intake
8-week follow- up with no specific diet
Outcomes
Primary Outcome Measures
Change in Premenstrual Syndrome Scale (PMSS)
Premenstrual Syndrome Scale (PMSS) was used for symptom assessment at initial and after two menstrual cycles.
Secondary Outcome Measures
Change in Quality of life scale Short Form (SF-36)
Full Information
NCT ID
NCT02809066
First Posted
June 16, 2016
Last Updated
June 21, 2016
Sponsor
Eastern Mediterranean University
1. Study Identification
Unique Protocol Identification Number
NCT02809066
Brief Title
Dietary Calcium Intake in Premenstrual Syndrome
Official Title
Effect of Sufficient Dietary Calcium Intake in Women With Premenstrual Syndrome
Study Type
Interventional
2. Study Status
Record Verification Date
June 2016
Overall Recruitment Status
Completed
Study Start Date
January 2015 (undefined)
Primary Completion Date
November 2015 (Actual)
Study Completion Date
January 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Eastern Mediterranean University
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Premenstrual Syndrome
Keywords
premenstrual syndrome, calcium, quality of life
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
31 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Interventional group
Arm Type
Experimental
Arm Description
8-week follow- up with dietary sufficient calcium intake
Arm Title
Control group
Arm Type
No Intervention
Arm Description
8-week follow- up with no specific diet
Intervention Type
Other
Intervention Name(s)
Sufficient dietary calcium intake in premenstrual syndrome
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in Premenstrual Syndrome Scale (PMSS)
Description
Premenstrual Syndrome Scale (PMSS) was used for symptom assessment at initial and after two menstrual cycles.
Time Frame
Eight weeks
Secondary Outcome Measure Information:
Title
Change in Quality of life scale Short Form (SF-36)
Time Frame
Eight weeks
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
28 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
Having any of metabolic diseases
Use oral contraceptive pill
user vitamins and minerals supplements
being smoker
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Merve Yurt, MS
Organizational Affiliation
Eastern Mediterranean University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Eastern Mediterranean University
City
Mersin
Country
Turkey
12. IPD Sharing Statement
Plan to Share IPD
Undecided
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Dietary Calcium Intake in Premenstrual Syndrome
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