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CTRI Number  CTRI/2023/08/056852 [Registered on: 23/08/2023] Trial Registered Prospectively
Last Modified On: 29/07/2023
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Preventive 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Does vitamin D3 has any effect in preventing preeclampsia and its complication in pregnant females 
Scientific Title of Study   Efficacy and safety of vitamin D3 supplementation in the prevention of pre-eclampsia and associated complications: A randomized controlled clinical study 
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 Savita 
Designation  Post graduate student 
Affiliation  BPS Govt. Medical College Khanpur Kalan, Sonipat 
Address  Department of Pharmacology, BPS Govt. Medical College Khanpur Kalan, Sonipat

Sonipat
HARYANA
131305
India 
Phone  8930559972  
Fax    
Email  savitanehra4@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Garima Bhutani 
Designation  Professor 
Affiliation  BPS Govt. Medical College Khanpur Kalan, Sonipat 
Address  Department of Pharmacology, BPS Govt. Medical College Khanpur Kalan, Sonipat

Sonipat
HARYANA
131305
India 
Phone  9992108132  
Fax    
Email  garimaahuja2010@yahoo.com  
 
Details of Contact Person
Public Query  
Name  Dr Savita 
Designation  Post graduate student 
Affiliation  BPS Govt. Medical College Khanpur Kalan, Sonipat 
Address  Department of Pharmacology, BPS Govt. Medical College Khanpur Kalan, Sonipat

Sonipat
HARYANA
131305
India 
Phone  8930559972  
Fax    
Email  savitanehra4@gmail.com  
 
Source of Monetary or Material Support  
BPS Govt. Medical College Khanpur Kalan, Sonipat, Haryana PIN- 131305 
 
Primary Sponsor  
Name  BPS Govt. Medical College Khanpur Kalan, Sonipat 
Address  Khanpur Kalan, Sonipat, Haryana 131305 
Type of Sponsor  Government medical college 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Savita  BPS Govt medical college  Room No. 2, Department of Obstetric and Gynecology, Khanpur Kalan, Sonipat, Haryana
Sonipat
HARYANA 		 8930559972

savitanehra4@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethical Committee BPSGMCW Khanpur Kalan Sonepat  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Pregnant Females 
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Standard of Care   Standard of Care as per guidelines for pregnancy females 
Intervention  Vitamin D3   The intervention group will receive vitamin D supplementation according to their serum vitamin D levels in addition to the Standard of care as per guidelines for pregnant females Sufficient vitamin D levels(30-60 ng/ml): Subjects will receive one dose of 60,000 IU vitamin D3 as a Cholecalciferol sachet orally with milk at night at 20 weeks of gestation. ï‚· Insufficient vitamin D levels (20-29 ng/ml): Subjects will receive four doses of 60,000 IU vitamin D3 as a Cholecalciferol sachet orally with milk at night at 20, 22, 24, and 26 weeks of gestation, making a total of 2,40,000 IU vitamin D3. ï‚· Deficient vitamin D levels (20 ng/ml): Subjects will receive eight doses of 60,000 IU vitamin D3 as a Cholecalciferol sachet orally with milk at night at 20, 22, 24, 26, 28, 30, 32, and 34 weeks of gestation, making a total of 4,80,000 IU vitamin D3  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  35.00 Year(s)
Gender  Female 
Details  1. Pregnant females who are willing to give written informed consent to participate in the study.
2. Pregnant females of age group 21-35 years with a singleton pregnancy and with a gestation age of 18-19 weeks.
 
 
ExclusionCriteria 
Details  1. Pregnant females who are unable or unwilling to give written informed consent.
2. Fetal abnormalities in the current or previous pregnancy
3. History of recurrent miscarriage
4. History of pre-eclampsia
5. History of hypertension
6. Twin pregnancy
7. Chronic kidney and liver disease
8. History of malignancy
9. Known case of osteomalacia
10. Recent history of therapeutic vitamin D3 consumption other than supplementation in the study
11. History of seizures
12. Known case of Diabetes mellitus

 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   An Open list of random numbers 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Pre-eclampsia assessment by blood pressure & proteinuria  Baseline 24 weeks, 28 weeks, 32 weeks & 36 weeks of gestation 
 
Secondary Outcome  
Outcome  TimePoints 
Serum vitamin D & calcium levels, kidney function tests, liver function tests, lipid profile and cordblood vitamin D levels  Baseline & 36 weeks 
 
Target Sample Size   Total Sample Size="86"
Sample Size from India="86" 
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 4 
Date of First Enrollment (India)   01/09/2023 
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="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
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
  1. What data in particular will be shared?
    Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response -  Statistical Analysis Plan

  3. Who will be able to view these files?
    Response - Researchers who provide a methodologically sound proposal.

  4. For what types of analyses will this data be available?
    Response - For individual participant data meta-analysis.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [savitanehra4@gmail.com].

  6. For how long will this data be available start date provided 16-11-2025 and end date provided 31-12-2026?
    Response - Beginning 3 months and ending 5 years following article publication.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary  


Pre-eclampsia is a syndrome characterized by pregnancy-induced hypertension and new-onset proteinuria occurring in the second half of pregnancy after 20 weeks of gestation in a previously normotensive woman. It is a multifactorial disorder that carries a high risk to mothers and fetuses worldwide. There is no specific treatment for pre-eclampsia. However, symptomatic treatment of pre-eclampsia primarily involves antihypertensive drugs such as Hydralazine, Labetalol, Nefidipine, Nitroprusside and anticonvulsant magnesium sulfate. Vitamin D deficiency in pregnant women can lead to a high risk of pre-eclampsia, gestational diabetes, preterm labour (<37 weeks), miscarriages, stillbirth, increased rate of caesarean section, low birth weight (≤2500gm), and immaturity. The present study is hypothesized to determine the effect of Cholecalciferol (vitamin D3) supplementation in the prevention of pre-eclampsia and associated complications in pregnant women. Eighty-six pregnant women fulfilling the above criteria will be included in the study. The total duration of the study will be 9 months. Information for this comparative clinical study, which includes, serum vitamin D and serum calcium levels, Liver FunctionTest/Renal Function Test, Plasma glucose levels, Blood Pressure, proteinuria, lipid profile at the beginning, and periodic intervals after adding vitamin D3 supplementation and feto-maternal outcomes at delivery, will be collected by using a predesigned structured proforma. Data will be entered into Microsoft excel sheet, an analytical software will be used for doing statistical analysis.  Mean ± S.D. will be calculated for quantitative data. Percentage and proportion will be calculated for categorical data. Student t-test will be used to find out the mean difference between the two groups. Repeated measure ANOVA will be used to find out the mean difference of the prospective time (i.e., follow-up). Post-hoc test, Bonferroni will be used. Chi-square test will be used to find out the association between categorical data using SPSS (version 22) software. A p-value of <0.05 will be considered as statistically significant.

 

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