| CTRI Number |
CTRI/2023/01/049144 [Registered on: 23/01/2023] Trial Registered Prospectively |
| Last Modified On: |
19/10/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Effect of Vitamin D in patients with excessively painful menstrual periods with low levels of Vitamin D |
|
Scientific Title of Study
|
Efficacy and safety of Vitamin D3 on primary dysmenorrhea with Vitamin D deficiency |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Sarita Goyal |
| Designation |
Professor |
| Affiliation |
Pt B. D Sharma PGIMS, Rohtak |
| Address |
3rd floor, Department of Pharmacology, PGIMS, Rohtak Haryana
Rohtak
HARYANA
124001
India |
| Phone |
9466495400 |
| Fax |
|
| Email |
drsaritagoyal@rediffmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Kanchan Kalra |
| Designation |
Post Graduate |
| Affiliation |
Pt B. D Sharma PGIMS, Rohtak |
| Address |
3rd floor, Department of Pharmacology, PGIMS, Rohtak Haryana
Rohtak
HARYANA
124001
India |
| Phone |
7988648979 |
| Fax |
|
| Email |
kanchankalra36@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Kanchan Kalra |
| Designation |
Post Graduate |
| Affiliation |
Pt B. D Sharma PGIMS, Rohtak |
| Address |
3rd floor, Department of Pharmacology, PGIMS, Rohtak Haryana
Rohtak
HARYANA
124001
India |
| Phone |
7988648979 |
| Fax |
|
| Email |
kanchankalra36@gmail.com |
|
|
Source of Monetary or Material Support
|
| Pt BD Sharma PGIMS Rohtak |
|
|
Primary Sponsor
|
| Name |
Pt BD Sharma PGIMS Rohtak |
| Address |
PGIMS, Rohtak Haryana, 124001 |
| Type of Sponsor |
Government medical college |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Kanchan Kalra |
Pt B.D Sharma PGIMS Rohtak |
Room number 179, First floor
Department of Obstetrics and Gynaecology
Ch. Ranbir Singh OPD
Pt BD Sharma PGIMS Rohtak, Haryana 124001
Rohtak
HARYANA |
7988648979
kanchankalra36@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Biomedical Research Ethics Committee Pt BD Sharma PGIMS/UHS, Rohtak |
Approved |
|
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Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: N72||Inflammatory disease of cervix uteri, |
|
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Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
NOT APPLICABLE |
NOT APPLICABLE |
| Intervention |
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, Visual analogue scale, Pictorial blood loss assessment, health related quality of life and Vitamin D3 levels at baseline and 8 weeks. |
|
|
Inclusion Criteria
|
| Age From |
14.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Female |
| Details |
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.
|
|
| ExclusionCriteria |
| Details |
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. |
|
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Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
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. |
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
|
| Outcome |
TimePoints |
1. Improvement in quality of life, by using SF-36 questionnaire.
2. Relief in menstrual bleeding using Pictorial Blood Loss Assessment Chart.
|
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. |
|
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Target Sample Size
|
Total Sample Size="65"
Sample Size from India="65"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="0" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
03/02/2023 |
| Date of Study Completion (India) |
04/01/2024 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Completed |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
|
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Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
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Brief Summary
|
Dysmenorrhea is one of the most common gynaecological diseases among women of the reproductive age group. It is defined as recurrent lower abdominal or pelvic pain that can extend to the back and thighs and can happen before, during, or after menstruation. The prevalence of dysmenorrhea found in published research ranges from 16 % to 91 %, with greater rates in adolescent populations. Primary dysmenorrhea is characterized by lower abdominal pain early in menstruation in the absence of any known pelvic disease. It starts possibly at 6-12 months after menarche and can continue till menopause. This pain usually begins around at the onset of menstruation and may continue up to 3 days. Non-steroidal anti-inflammatory drugs (NSAIDs) are the main line of treatment for managing primary dysmenorrhea, but their main drawback is that they are associated with a lot of adverse effects like stomach ache, heart burn etc. Vitamin D deficiency is very common, nowadays, due to dietary deficiencies and lack of exposure to sunlight and, it is commonly encountered in patients with primary dysmenorrhea. Some studies have shown that abnormal serum vitamin D levels may contribute to increased pain during menstruation and taking Vitamin D supplements may help in relieving symptoms of primary dysmenorrhea. The anti-inflammatory properties of vitamin D, which are mediated by decreased cytokine levels like IL-6 and TNF-alfa and by reducing the generation of prostaglandins, may be the mechanism by which it treats primary dysmenorrhea. So, this prsopective interventional study is being conducted to know the possible role of Vitamin D in lowering the intensity of primary dysmenorrhea symptoms, bleeding and decreasing the frequency of analgesic usage. A total of 65 patients presenting in the Obsterics & Gynaecology outpatient clinic, females diagnosed with primary dysmenorrhea will be enrolled in the study as per inclusion and exclusion criteria. Written informed consent will be taken from each participant/LAR before enrolling them. A customized questionnaire in the form of case record form (CRF) will be used to collect demographic, clinical information and anthropometric measurements from the participants. Blood samples will be drawn from them to estimate serum Vitamin D3 levels at baseline and 8 weeks. The patients will be also asked questions out of a questionnaire - for assessment of WaLIDD (working ability, location, intensity, days of pain and dysmenorrhea) score, dysmenorrheal pain (VAS score), amount of bleeding (PBLAC score), Number of analgesics, and quality of life (Sf 36 questionnaire). The patient will be followed up at 4 weeks and 8 weeks, and again will be assessed for the questionnaires mentioned above. This study is being conducted to evaluate the relationship between supplementation of Vitamin D3 and intensity of primary dysmenorrhea symptoms and its overall impact on quality of life.
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