Effect of Vitamin D in patients with excessively painful menstrual periods with low levels of Vitamin D

Not Applicable

Completed

Conditions: Health Condition 1: N72- Inflammatory disease of cervix uteri

Registration Number: CTRI/2023/01/049144

Lead Sponsor: Pt BD Sharma PGIMS Rohtak

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 0

Inclusion Criteria

1. Patients falling between the age group of 14 – 40 years.

2. Patients with painful and relatively regular menstruation lasting 3-7 days for at least 4 consecutive painful periods in recent six cycles.

3. Patient or legal guardian willing to provide written informed consent.

4. Patients with Visual Analogue pain score of more than equal to 45mm.

5. Patients with serum vitamin D levels < 30 ng/ml.

Exclusion Criteria

1. Patients diagnosed with secondary dysmenorrhea due to uterine disorders (like fibroid, polyps, endometrial hypertrophy and endometriosis) and ovarian disorders (ovarian cysts and polycystic ovaries).

2. History of-

•Abnormal vaginal and cervical secretions.

•Epilepsy, cardiovascular, hepatic or kidney diseases.

•Any mental illness and drug use.

•Significant gastrointestinal or genitourinary procedure.

•Any endocrine procedure.

•Any abdominal or pelvic surgery.

•Thyroid disorders.

3. Ongoing treatment with-

•Anticoagulants.

•Hormonal contraceptives.

•Mineral or vitamin supplementation in the past 3 months.

4.Any allergic reactions to the study drug.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1. Decrease in WaLIDD score. <br/ ><br>2. Improvement in pain intensity by using the Visual Analogue Scale (VAS). <br/ ><br>3. Improvement in serum Vitamin D3 levels at baseline and 8 weeks and its correlation with decrease in WaLIDD score and improvement as per VAS. <br/ ><br>4. Number of analgesic medications used.Timepoint: Participants will be assessed initially during enrollment for baseline parameters and will be followed up at 4 weeks and 8 weeks for assessment of WaLIDD score, VAS score, number of analgesics used and serum Vitamin D3 levels will be assessed at baseline and 8 weeks.

Secondary Outcome Measures

Name	Time	Method
1.Improvement in quality of life, by using SF-36 questionnaire. <br/ ><br>2.Relief in menstrual bleeding using Pictorial Blood Loss Assessment Chart. <br/ ><br>Timepoint: Participants will be assessed initially during baseline parameters and will be followed up at 4 weeks and 8 weeks for assessment of Health related quality of life and Pictorial blood loss assessment chart score.