| CTRI Number |
CTRI/2013/10/004056 [Registered on: 10/10/2013] Trial Registered Retrospectively |
| Last Modified On: |
08/10/2013 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Preventive |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
To study the prevalence of vitamin D deficiency in pregnant women and the effect of supplementation in preventing adverse pregnancy outcome |
|
Scientific Title of Study
|
Vitamin D deficiency in pregnancy: Its prevalence and role of supplementation in preventing adverse maternal and fetal outcome: A double blind randomized placebo-controlled trial. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
Other |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Rimpi Singla |
| Designation |
Senior Research Associate |
| Affiliation |
Deptt of Obstetrics and Gynaecology, PGIMER |
| Address |
sector-12, PGIMER
Chandigarh
CHANDIGARH
160012
India |
| Phone |
01722756345 |
| Fax |
01722747909 |
| Email |
sukantgarg@yahoo.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Neelam Aggarwal |
| Designation |
Assistant Professor |
| Affiliation |
Deptt of Obstetrics and Gynaecology, PGIMER |
| Address |
PGIMER, SECTOR 12
Chandigarh
CHANDIGARH
160012
India |
| Phone |
01722756345 |
| Fax |
01722747909 |
| Email |
chddialysis@rediffmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Rimpi Singla |
| Designation |
senior research associate |
| Affiliation |
Deptt of Obstetrics and Gynaecology,PGIMER |
| Address |
PGIMER, sector-12
Chandigarh
CHANDIGARH
160012
India |
| Phone |
01722756345 |
| Fax |
01722747909 |
| Email |
sukantgarg@yahoo.com |
|
|
Source of Monetary or Material Support
|
| Council of Scientific &Industrial Research,
Pusa, New Delhi. 110012
Deptt of Obstetrics & Gynaecology,
PGIMER, Chandigarh. 160012
Department of Gastroenterology,PGIMER, Chandigarh.
|
|
|
Primary Sponsor
|
| Name |
CSIR |
| Address |
PUSA ROAD
NEW DELHI |
| Type of Sponsor |
Government funding agency |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| PGIMER |
SECTOR 12
Chandigarh |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Lakhbir Dhaliwal |
Deptt of Obstetrics and Gynaecology |
PGIMER
sector 12
160012
Chandigarh
CHANDIGARH |
01722756345
01722747909
dhaliwalgynae.pgimer@yahoo.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| PGIMER Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
Vitamin D deficiency
Maternal problems : preeclampsia, gestational diabetes mellitus, gall bladder dysfunction
Fetal problems: intra uterine growth restriction
, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Identical looking Placebo (Starch) |
Identical looking Placebo to be taken with a glass of milk for 5 days
|
| Intervention |
vitamin D (cholecalciferol) |
60000IU/d to be taken with a glass of milk for 5 days |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
35.00 Year(s) |
| Gender |
Female |
| Details |
Inclusion Criteria:
Singleton pregnancy
normotensive
|
|
| ExclusionCriteria |
| Details |
?Pre- existing medical conditions like rheumatoid arthritis, thyroid, parathyroid or adrenal diseases, hepatic or renal failure, metabolic bone disease, diabetes mellitus, malabsorption, essential hypertension
?Medications influencing bone, vitamin D or calcium metabolism
?Preexisting gall bladder disease
|
|
|
Method of Generating Random Sequence
|
Permuted block randomization, variable |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Incidence of
Gestational Diabetes Mellitus
Preeclampsia
Gall bladder dysfunction
Intra Uterine Growth Restriction
|
Through pregnancy
delivery |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Prevalence of vitamin D deficiency
Effect of vitamin D supplementation on labor and delivery
period of gestation at delivery
duration of labor
mode of delivery
post partum complications
Neonatal outcome
apgar score
birth weight
small for gestational age
head circumference
NNN admission
? length of the newborn
|
During labor and delivery
and postnatal |
|
|
Target Sample Size
|
Total Sample Size="280"
Sample Size from India="280"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
Phase 3 |
|
Date of First Enrollment (India)
|
19/11/2010 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="3"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
None yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
This study is a randomized, double blind, parallel group, single- centre trial to study the role of vitamin D supplementation during pregnancy in preventing adverse maternal and fetal outcomes. Planned to enroll 280 women. Vitamin D level will be assessed. Patients will be randomized to receive 60000 IU/d of vitamin D for 5 days or a similar looking placebo for 5 days. All the women will be followed through pregnancy and incidence of preeclampsia, gestational diabetes mellitus, gall bladder dysfunction and intrauterine growth restriction, duration of gestation will be compared in either groups. At birth neonatal anthropometry and apgar score will be compared between two groups |