Premenstrual Syndrome-PMS
Conditions
Keywords
Calcium, Vitamin-D, Premenstrual Symptoms
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
Detailed description
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
Interventions
DIETARY_SUPPLEMENTvitamin D (cholecalciferol) supplementation
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
OTHERPlacebo
Placebo was given for 12 weeks
Sponsors
Haleema Sadia
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 40 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Depressed mood | 6 Months | Outcome was assessed by using Premenstrual Symptoms Screening Tool-Adolescent (PSST-A) questionnaire in both groups and analyzed. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Decreased interest in work activities | 6 Months | Outcome was assessed by using Premenstrual Symptoms Screening Tool-Adolescent (PSST-A) questionnaire in both groups and analyzed. |
| Difficulty in concentration | 6 Months | Outcome was assessed by using Premenstrual Symptoms Screening Tool-Adolescent (PSST-A) questionnaire in both groups and analyzed. |
Countries
Pakistan
Outcome results
None listed