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Completed

NCT Number: NCT07078708

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

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

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Key information

Age range

18 year–40 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Avicenna Hospital Lahore

Lahore, Punjab Province, 54000, Pakistan

About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • 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.

Treatment and study plan

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

Placebo

Other

Placebo was given for 12 weeks

Primary outcomes

  1. Depressed mood

    Time frame: 6 Months

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

Secondary outcomes

  1. Decreased interest in work activities

    Time frame: 6 Months

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

  2. Difficulty in concentration

    Time frame: 6 Months

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

Sponsors and collaborators

Lead sponsor

Haleema Sadia

Other

Registry information

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Jul 22, 2025
Registry last updated
Jul 22, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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