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

Efficacy and safety of Vitamin D3 on primary dysmenorrhea with Vitamin D deficiency

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2023/01/049144
Enrollment
65
Registered
2023-01-23
Start date
Unknown
Completion date
Unknown
Last updated
2024-11-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: N72- Inflammatory disease of cervix uteri

Interventions

Intervention1: Vitamin D3: Vitamin D3 60,000 IU will be given once a week for a total duration of 8 weeks. The enrolled patients will be assessed at baseline, 4 weeks and 8 weeks for WaLIDD score, Vis

Sponsors

Pt BD Sharma PGIMS Rohtak
Lead Sponsor

Eligibility

Inclusion criteria

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

Exclusion criteria

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.

Design outcomes

Primary

MeasureTime frame
1. Decrease in WaLIDD score. 2. Improvement in pain intensity by using the Visual Analogue Scale (VAS). 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. 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

MeasureTime frame
1. Improvement in quality of life, by using SF-36 questionnaire. 2. Relief in menstrual bleeding using Pictorial Blood Loss Assessment Chart. 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.

Countries

India

Contacts

Public ContactDr Kanchan Kalra

Pt B. D Sharma PGIMS, Rohtak

kanchankalra36@gmail.com7988648979

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026