Effectiveness of Non-hormonal Treatment on Moderate to Severe Premenstrual Syndrome

NCT07078708 | Completed

• 1 other identifier: 101
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

A double-blind, randomised, placebo-controlled, parallel trial was conducted involving 100 females aged 18-40, all of whom presented with premenstrual syndrome at the Department of Gynecology and Obstetrics, Avicenna Medical College Hospital, Lahore, Pakistan. Participants were randomly assigned to two groups of equal size: One group received vitamin D supplementation at a dose of 50,000 IU every two weeks along with a daily intake of 1,000 mg of calcium, whereas the comparison group was administered a placebo under the same conditions for 12 weeks. All the participants were examined on premenstrual syndrome with the Premenstrual Symptoms Screening Tool-Adolescent (PSST-A) questionnaire

Conditions

Premenstrual Syndrome-PMS

Keywords

Calcium; Vitamin-D; Premenstrual Symptoms

Outcome Measures

Primary Outcomes (1)

• Depressed mood

  Outcome was assessed by using Premenstrual Symptoms Screening Tool-Adolescent (PSST-A) questionnaire in both groups and analyzed.

  6 Months

Secondary Outcomes (2)

• Decreased interest in work activities

  6 Months

• Difficulty in concentration

  6 Months

Study Arms (2)

Participants taking calcium and Vitamin D

EXPERIMENTAL

In this group participants received vitamin D supplementation at a dose of 50,000 IU every two weeks along with a daily intake of 1,000 mg of calcium for 12 weeks. Participants symptoms were assessed at baseline, one month, three months, and six months following the commencement of the study.

Dietary Supplement: vitamin D (cholecalciferol) supplementation

Participants taking placebo

PLACEBO COMPARATOR

In this group participants received placebo for 12 weeks. Participants symptoms were assessed at baseline, one month, three months, and six months following the commencement of the study.

Other: Placebo

Interventions

vitamin D (cholecalciferol) supplementation DIETARY_SUPPLEMENT

Vitamin D supplementation at a dose of 50,000 IU every two weeks along with a daily intake of 1,000 mg of calcium for 12 weeks

Participants taking calcium and Vitamin D

Placebo OTHER

Placebo was given for 12 weeks

Participants taking placebo

Eligibility Criteria

• Age: 18 Years - 40 Years
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Participants aged 18-40 years with moderate to severe PMS

You may not qualify if:

• Individuals exhibiting symptoms of malnutrition or requiring calcium+vitamin D supplementation.
• Individuals with systemic diseases such as sepsis, hemodynamic instability, or acute meningitis; diarrhoea.
• Individuals with known intolerance or sensitivity to calcium vitamin D or calcium vitamin D containing compounds.
• smokers, Individuals with exposure to stressful situations or a history of mental illness.

Sponsors & Collaborators

• Haleema Sadia: lead

Study Sites (1)

Avicenna Hospital Lahore

Lahore, Punjab Province, 54000, Pakistan

Location

MeSH Terms

Conditions

Premenstrual Syndrome

Interventions

Vitamin D; Cholecalciferol; Dietary Supplements

Condition Hierarchy (Ancestors)

Menstruation Disturbances; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Secosteroids; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Cholestenes; Cholestanes; Sterols; Membrane Lipids; Lipids; Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Dr Haleema Sadia

Study Record Dates

• First Submitted: July 13, 2025
• First Posted: July 22, 2025
• Study Start: June 1, 2024
• Primary Completion: November 30, 2024
• Study Completion: November 30, 2024
• Last Updated: July 22, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)