Dietary Calcium Intake in Premenstrual Syndrome

Premenstrual Syndrome Clinical Trial

Official title:

Effect of Sufficient Dietary Calcium Intake in Women With Premenstrual Syndrome

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02809066
• Other study ID #: 2015/10-03
• Status: Completed
• Phase: N/A
• First received: June 16, 2016
• Last updated: June 21, 2016
• Start date: January 2015
• Est. completion date: January 2016

Study information

• Verified date: June 2016
• Source: Eastern Mediterranean University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Turkey: Ministry of Health
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 31
• Est. completion date: January 2016
• Est. primary completion date: November 2015
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 20 Years to 28 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Premenstrual Syndrome
• Syndrome

Intervention

Other:
• Sufficient dietary calcium intake in premenstrual syndrome
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.

Locations

Country	Name	City	State
Turkey	Eastern Mediterranean University	Mersin

Sponsors (1)

Lead Sponsor	Collaborator
Eastern Mediterranean University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Premenstrual Syndrome Scale (PMSS)	Premenstrual Syndrome Scale (PMSS) was used for symptom assessment at initial and after two menstrual cycles.	Eight weeks	Yes
Secondary	Change in Quality of life scale Short Form (SF-36)		Eight weeks	Yes