| CTRI Number |
CTRI/2025/11/097473 [Registered on: 14/11/2025] Trial Registered Prospectively |
| Last Modified On: |
14/11/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Biological
Preventive
Screening |
| Study Design |
Other |
|
Public Title of Study
|
Role of supplementation of Vitamin D in prevention of hypertensive disorders of pregnancy |
|
Scientific Title of Study
|
Role of supplementation of Vitamin D in prevention of preeclampsia |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Saumya Singh |
| Designation |
Post graduate resident |
| Affiliation |
ABVIMS Dr Ram Manohar Lohia Hospital |
| Address |
Department of Obstetrics and Gynecology Dr Ram Manohar Lohia HospitalBaba Kharak Singh RoadConnaught Place,New Delhi
Baba Kharak Singh Road Connaught Place New Delhi
New Delhi
DELHI
110001
India |
| Phone |
9304994328 |
| Fax |
|
| Email |
singh16saumya12@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Saumya Singh |
| Designation |
Post graduate resident |
| Affiliation |
ABVIMS Dr Ram Manohar Lohia Hospital |
| Address |
Department of obstetrics and gynecology Dr Ram Manohar Lohia Hospital,Baba Kharak Singh Road,Connaught Place,New Delhi
Baba Kharak Singh Road,Connaught Place,New Delhi
New Delhi
DELHI
110001
India |
| Phone |
9304994328 |
| Fax |
|
| Email |
singh16saumya12@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Saumya Singh |
| Designation |
Post graduate resident |
| Affiliation |
ABVIMS Dr Ram Manohar Lohia Hospital |
| Address |
Department of Obstetrics and Gynecology Dr Ram Manohar Lohia Hospital,Baba Kharak Singh Road,Connaught Place,New Delhi
Baba Kharak Singh Road,Connaught Place,New Delhi
New Delhi
DELHI
110001
India |
| Phone |
9304994328 |
| Fax |
|
| Email |
singh16saumya12@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
RML Hospital |
| Address |
Department of Obstetrics and Gynecology,ABVIMS Dr Ram Manohar Lohia Hospital,Baba Kharak Singh Road,Connaught Place,New Delhi 110001 |
| Type of Sponsor |
Research institution and hospital |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Dr Kamna Datta |
ABVIMS Dr Ram Manohar Lohia Hospital,Baba Kharak Singh Road,Connaught Place,New Delhi 110001 |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Saumya Singh |
ABVIMS Dr Ram Manohar Lohia Hospital |
Maternal Nursing Home Department of Obstetrics and Gynecology
New Delhi
DELHI |
9304994328
singh16saumya12@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| The Institutional Ethics Commiittee,ABVIMS Dr RML Hospital,New Delhi |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Primigravida with singleton,low risk pregnancy. Gestational age between 14-18 weeks. Age between 18 to 35 years. Willing to give informed consent and comply with study procedures. |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
No Vitamin D Supplementation |
All consecutively registered low risk primigravida with singleton live pregnancy between 14-18 weeks of gestation attending antenatal clinic at Dr RMLH will be recruited according to the inclusion and exclusion criteria. |
| Intervention |
Vitamin D Supplementation |
All consecutively registered low risk primigravida with singleton live pregnancy between 14-18 weeks of gestation attending antenatal clinic at Dr RMLH will be recruited according to the
inclusion and exclusion criteria. A written informed consent will be obtained. 3 mL blood sample will be drawn from the antecubital vein collected in red vial(clot activator) to measure serum
25(OH)vitamin D. After that she will be given Vit D3 capsule(60k IU) orally under supervision at the ANC clinic and then monthly till delivery. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
35.00 Year(s) |
| Gender |
Female |
| Details |
1.Primigravida with singleton,low risk pregnancy
2.Gestational age between 14-18 weeks, confirmed by LMP or early ultrasound
3.Age between 18 to 35 years
4.Willing to give informed consent and comply with study procedures |
|
| ExclusionCriteria |
| Details |
History of preeclampsia or eclampsia in previous pregnancies. Multiple pregnancy e.g. twins, triplets. Chronic medical disorders including Chronic hypertension, pre existing diabetes
mellitus, Chronic renal disease, autoimmune disorders such as SLE. Malabsorption syndromes eg. Celiac disease, crohn’s disease. Severe anemia Hb less than 7 g per dl. Parathyroid disorders or other endocrine disorders affecting calcium or vitamin D metabolism. Known fetal anomalies detected via ultrasound. |
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Preeclampsia |
At 14-18 weeks followed by monthly till delivery |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Gestational age at delivery,mode of delivery ,APGAR,birth
weight,admission in NICU. |
At 14-18 weeks followed by monthly till delivery |
|
|
Target Sample Size
|
Total Sample Size="250"
Sample Size from India="250"
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
|
N/A |
|
Date of First Enrollment (India)
|
01/12/2025 |
| 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="1"
Months="4"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - YES
- What data in particular will be shared?
Response - All of the individual participant data collected during the trial, after de-identification.
- What additional supporting information will be shared?
Response - Study Protocol
Response - Statistical Analysis Plan
Response - Informed Consent Form
Response - Clinical Study Report
- Who will be able to view these files?
Response - Anyone
- For what types of analyses will this data be available?
Response - To achieve aims in the approved proposal.
- By what mechanism will data be made available?
Response - To gain access, data requestors will need to sign a data access agreement. Data are available for 5 years at a third party website (NIL).
- For how long will this data be available start date provided 18-07-2025 and end date provided 17-12-2026?
Response - Beginning 3 months and ending 5 years following article publication.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
|
Brief Summary
|
The study will be conducted in the Department of Obstetrics and Gynecology and Department of Biochemistry at Atal Bihari Vajpayee Institute of Medical Sciences and Dr Ram Manohar Lohia Hospital, New Delhi. It will be a Prospective case control type of study. Duration of the study will be from 11th June 2025 to 10th November 2026.Sample size -In a study A prospective comparative interventional study by by Sinha et al. (2019)22 in Bhagalpur, Bihar, involved 60 pregnant women divided into two groups. The incidence of preeclampsia was 16.7 percent in the non-supplemented group compared to 6.7 percent in the vitamin D supplemented group, indicating a significant reduction in risk (p equal to 0.041) . Based on the formula and values given above, the sample size calculated per group is approximately 267 (total 534). Thus, with 80 percent power and 95 percent confidence interval, the minimum sample size required for the study is 267 in each group (total 534). It is proposed to recruit 125 pregnant women in each group (case and control groups) as a convenient sample size, which makes a total of 250.
|