NCT02809066

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
31

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2015

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2015

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2015

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2016

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

June 16, 2016

Completed
6 days until next milestone

First Posted

Study publicly available on registry

June 22, 2016

Completed
Last Updated

June 22, 2016

Status Verified

June 1, 2016

Enrollment Period

10 months

First QC Date

June 16, 2016

Last Update Submit

June 21, 2016

Conditions

Premenstrual Syndrome

Keywords

premenstrual syndromecalciumquality of life

Outcome Measures

Primary Outcomes (1)

  • Change in Premenstrual Syndrome Scale (PMSS)

    Premenstrual Syndrome Scale (PMSS) was used for symptom assessment at initial and after two menstrual cycles.

    Eight weeks

Secondary Outcomes (1)

  • Change in Quality of life scale Short Form (SF-36)

    Eight weeks

Study Arms (2)

Interventional group

EXPERIMENTAL

8-week follow- up with dietary sufficient calcium intake

Other: Sufficient dietary calcium intake in premenstrual syndrome

Control group

NO INTERVENTION

8-week follow- up with no specific diet

Interventions

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.

Interventional group

Eligibility Criteria

Age20 Years - 28 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • Having any of metabolic diseases
  • Use oral contraceptive pill
  • user vitamins and minerals supplements
  • being smoker

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Eastern Mediterranean University

Mersin, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Premenstrual Syndrome

Condition Hierarchy (Ancestors)

Menstruation DisturbancesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Merve Yurt, MS

    Eastern Mediterranean University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Senior Instructor

Study Record Dates

First Submitted

June 16, 2016

First Posted

June 22, 2016

Study Start

January 1, 2015

Primary Completion

November 1, 2015

Study Completion

January 1, 2016

Last Updated

June 22, 2016

Record last verified: 2016-06

Locations

TU(1)