Prevention of preeclampsia by taking vitamin D supplements
Design
Two-arm parallel group randomised trial with blinding
Settings and conduct
Gynecology department unit III of Nishtar Hospital, Multan
Participants/Inclusion and exclusion criteria
Patients who presented at the outpatient department of the hospital for prenatal care and had a previous history of preeclampsia during a previous pregnancy were included. Patients with renal insufficiency, cardiac disease, and hypertension before pregnancy, lack of confidence in cooperation, immunological disease and leaving during study were excluded
Intervention groups
In the intervention group, patients were given 50000 IU capsules of vitamin D3 once every 2 weeks.
Main outcome variables
Occurrence of Preeclampsia
Type of delivery
Abortion rate
General information
Reason for update
Acronym
PREV-D
IRCT registration information
IRCT registration number:IRCT20230814059146N1
Registration date:2023-08-22, 1402/05/31
Registration timing:retrospective
Last update:2023-08-22, 1402/05/31
Update count:0
Registration date
2023-08-22, 1402/05/31
Registrant information
Name
Saima Shahzad
Name of organization / entity
Nishtar Medical University
Country
Pakistan
Phone
+92 300 7195857
Email address
saimashahzad35177@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-01-19, 1400/10/29
Expected recruitment end date
2022-12-19, 1401/09/28
Actual recruitment start date
2022-01-19, 1400/10/29
Actual recruitment end date
2022-12-19, 1401/09/28
Trial completion date
2023-12-19, 1402/09/28
Scientific title
Comparing the Impact of Vitamin D Supplementation with Placebo on Pre-eclampsia Prevention in Pregnant Women
Public title
Effect of Vitamin D Supplement on Prevention of Preeclampsia in Pregnant Women
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Presented with prenatal care in outpatient department
previous history of Preeclampsia
gestational age of >20 weeks
Exclusion criteria:
History of renal insufficiency
History of cardiac disease
History of hypertension before pregnancy
lack of confidence in cooperation
history of immunological disease
patient willing to leave during trial
Age
From 18 years old to 40 years old
Gender
Female
Phase
2-3
Groups that have been masked
Participant
Outcome assessor
Data analyser
Sample size
Target sample size:
250
Actual sample size reached:
250
Randomization (investigator's opinion)
Randomized
Randomization description
stratfied simple random sampling technique, using random numbers first stratified by gender_
Blinding (investigator's opinion)
Single blinded
Blinding description
single blinding would involve ensuring that the participants (pregnant women) are unaware of whether they are receiving the actual Vitamin D supplementation or a placebo. This helps minimize bias and ensures that the results of the study are not influenced by the participants' or researchers' expectations or beliefs.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Institutional Ethical Review Board (IERB)
Street address
Nishtar Hospital, Multan
City
Multan
Postal code
66000
Approval date
2022-01-01, 1400/10/11
Ethics committee reference number
041
Health conditions studied
1
Description of health condition studied
Pre-eclampsia: The occurrence of hypertension in pregnancy after 20 weeks of gestation
ICD-10 code
014
ICD-10 code description
Pre-eclampsia
Primary outcomes
1
Description
Pre-eclampsia (Blood pressure measurement and proteinuria)
Timepoint
From 20 weeks till 36 weeks of gestation, (every two weeks)
Method of measurement
Blood pressure measurement using sphygmomanometer, and proteinuria by dipstick method
Secondary outcomes
1
Description
Type of delivery
Timepoint
At 40 weeks approximately
Method of measurement
Visual and medical record
2
Description
Abortion rate
Timepoint
From 20 weeks till abortion
Method of measurement
Based on history and medical records
Intervention groups
1
Description
Intervention group: In intervention group patients were given 50000 IU capsules of vitamin D3 once every 2 weeks. All patients were advised to take medicine (placebo or vitamin D) till 36 weeks of gestation. Preeclampsia was diagnosed on the basis of clinical examination (Blood pressure of140/90 mm Hg or higher) and laboratory investigation. (Protein urea +1). Blood pressure monitoring was done on every 15 days until the use of medicine.
Category
Treatment - Drugs
2
Description
Control group:. The control group was prescribed placebo in the form a another vitamin supplementation not containing vitamin D. All patients were advised to take medicine (placebo or vitamin D) till 36 weeks of gestation. Preeclampsia was diagnosed on the basis of clinical examination (Blood pressure of140/90 mm Hg or higher) and laboratory investigation. (Protein urea +1). Blood pressure monitoring was done on every 15 days until the use of medicine.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
outpatient department of gynecology department
Full name of responsible person
Dr. Saima
Street address
Nishtar Hospital, Multan
City
Multan
Postal code
66000
Phone
+92 312 8443876
Email
saimashahzad35177@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
DME of Nishtar hospital
Full name of responsible person
department of medical education
Street address
Nishtar hospital, Multan
City
Multan
Postal code
66000
Phone
+92 61 4702121
Email
nmu@edu.pk
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
DME of Nishtar hospital
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
DME, Nishtar hospital Multan
Full name of responsible person
Dr. Saima
Position
Assistant professor
Latest degree
Subspecialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Nishtar hospital, Multan
City
Multan
Province
Punjab
Postal code
66000
Phone
+92 311 8443876
Email
saimashahzad35177@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Nishtar Medical University
Full name of responsible person
Saima Shahzad
Position
Assistant Professor
Latest degree
Medical doctor
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Nishtar hospital, Multan
City
Multan
Province
Punjab
Postal code
66000
Phone
+92 300 7195857
Fax
Email
saimashahzad35177@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Nishtar Medical University
Full name of responsible person
Saima Shahzad
Position
Assistant Professor
Latest degree
Medical doctor
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Nishtar hospital, Multan
City
Multan
Province
Punjab
Postal code
66000
Phone
+92 300 7195857
Fax
Email
saimashahzad35177@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
due to cultural reasons, patients usually hide personal data on individual basis
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
No - There is not a plan to make this available
Data Dictionary
No - There is not a plan to make this available
Title and more details about the data/document
Clinical study types, desgin, and data stats
When the data will become available and for how long
till the end of 2023, for lifelong
To whom data/document is available
all public
Under which criteria data/document could be used
only for citations
From where data/document is obtainable
google scholar and personal email
What processes are involved for a request to access data/document