| CTRI Number |
CTRI/2012/11/003085 [Registered on: 05/11/2012] Trial Registered Retrospectively |
| Last Modified On: |
02/10/2012 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Case Control Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
vitamin D deficiency in women after menopause with uterus prolapse and urinary leakage |
|
Scientific Title of Study
|
Vitamin D deficiency in postmenopausal women with pelvic floor disorders |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| Nil |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr R N Preethi |
| Designation |
Assistant professor |
| Affiliation |
Christian Medical College hospital |
| Address |
Department of obstetrics and gynecology,Christian medical college, vellore.
Vellore
TAMIL NADU
632004
India |
| Phone |
0416-2283397 |
| Fax |
|
| Email |
rnpreethi@yahoo.co.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Aruna Kekre |
| Designation |
Professor |
| Affiliation |
Christian Medical College hospital |
| Address |
Unit II, Department of OBstetrics and gynecology, Christian medical college, Vellore.
Vellore
TAMIL NADU
632004
India |
| Phone |
0416-2283397 |
| Fax |
|
| Email |
ankekre@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Aruna Kekre |
| Designation |
Professor |
| Affiliation |
Christian Medical College hospital |
| Address |
Unit II, Department of OBstetrics and gynecology, Christian medical college, Vellore.
Vellore
TAMIL NADU
632004
India |
| Phone |
0416-2283397 |
| Fax |
|
| Email |
ankekre@gmail.com |
|
|
Source of Monetary or Material Support
|
| Christian Medical college. |
|
|
Primary Sponsor
|
| Name |
christian medical college hospital |
| Address |
Christian Medical college hospital, vellore |
| Type of Sponsor |
Private 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 RN Preethi |
Department of obstetrics and gynecology |
Christian Medical college hospital, Vellore
Vellore
TAMIL NADU |
04162283397
rnpreethi@yahoo.co.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Christian medical college hospital etics committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
Postmenopausal women attending the outpatient clinic in gynecology department with urinary incontinence and prolapse uterus(cases) and those without urinary incontinence or prolapse (controls), |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
40.00 Year(s) |
| Age To |
75.00 Year(s) |
| Gender |
Female |
| Details |
Postmenopausal women without symptoms or signs of prolapse/ stress urinary incontinence formed the control group and postmenopausal women with symptoms or signs of prolapse and urinary incontinence formed the cases |
|
| ExclusionCriteria |
| Details |
1. Previously treated with vitamin D supplementation
2. Chronic renal disease.
3. Bed ridden patients |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Association of Vitamin D deficiency and pelvic floor disorders- (Prolapse and stress urinary incontinence) |
At the time of recruitment |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Vitamin D deficiency prevalence in the postmenopausal women |
At the time of recruitment |
|
|
Target Sample Size
|
Total Sample Size="120"
Sample Size from India="120"
Final Enrollment numbers achieved (Total)= ""
Final Enrollment numbers achieved (India)="" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
01/02/2011 |
| Date of Study Completion (India) |
Date Missing |
| 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)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
Not published yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
INTRODUCTION Pelvic floor disorders (PFD) is a group of disorders including pelvic organ prolapse (POP), urinary incontinence (UI) and fecal incontinence . Recent studies show the role of vitamin D in muscle strength and neuromuscular function . The various factors contributing to pelvic floor disorders include multiparity, mode of delivery, instrumental delivery, obesity, aging, collagen defects and menopause. This indicates that postmenopausal women are more likely to develop symptoms of PFD. Elderly women are more likely to be vitamin D deficient due to the reduced activity of the skin to convert 25 hydroxy cholecalciferol to active form as the age advances . In this study we intend to evaluate the possible association of vitamin D deficiency and pelvic floor disorders especially POP and UI in postmenopausal women.
METHODS
60 women in the control group formed by postmenopausal women without signs and symptoms of prolapse or stress urinary incontinece and 60 postmenopausal women in the case group with signs or symptoms of pelvic floor disorders were included.Women with chronic renal illness, previous vitamin D supplementation, non ambulant chronically bed ridden patients were excluded from the study. Serum vitamin D levels were measured at the time of recruitment in both the groups and proforma containing detailed history for risk factors of vitamin D deficiency and pelvic floor disorders was completed. The data analyzed by SPSS software. |