Due to the adverse effects of vitamin D deficiency on the fetus and mother,
Design
In this study, pregnant women living in Shahroud in the age range of 18 to 45 years and gestational age under 14 weeks with a level of vitamin D below 20 ng / ml are included in the study. The sample size is 55 people and randomly divided into three groups receiving different doses. Vitamin D is divided into which the first group receives vitamin D 1000 daily, the second 2000 daily and the third 4000 daily
Settings and conduct
In this study, pregnant mothers living in Shahroud in the age range of 14 to 45 years and gestational age under 14 weeks referring to the clinic of Bahar Hospital in Shahroud are selected and their vitamin D level is measured with ELISA and vidas kit. Vitamin D levels below 20 ng are included in the study
These people are randomly divided into three groups receiving different doses of vitamin D. Vitamin D levels are determined and compared in groups at 28 weeks of gestation
Participants/Inclusion and exclusion criteria
Pregnant mothers living in Shahroud in the age range of 18 to 45 years and with a gestational age of less than 14 weeks,
Intervention groups
Pregnant mothers living in Shahroud in the age range of 18 to 45 years and with a gestational age of less than 14 weeks, are selected and entered the study with vitamin D levels below 20 ng / ml and were randomly divided into three groups receiving different doses of vitamin D .
Main outcome variables
The most important outcome evaluated in this study is the response to vitamin D treatment in pregnant women.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20211101052937N1
Registration date:2021-12-28, 1400/10/07
Registration timing:retrospective
Last update:2021-12-28, 1400/10/07
Update count:0
Registration date
2021-12-28, 1400/10/07
Registrant information
Name
fatemeh Sadri
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 23 3222 1761
Email address
fatemeh.sadri1374@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-01-20, 1399/11/01
Expected recruitment end date
2021-09-21, 1400/06/30
Actual recruitment start date
2021-01-25, 1399/11/06
Actual recruitment end date
2021-10-22, 1400/07/30
Trial completion date
2021-10-22, 1400/07/30
Scientific title
Assessment of optimal vitamin D dose for treatment of hypovitaminosis D in pregnant women
Public title
The effect of vitamin D in the treatment of vitamin D deficiency
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
18-45 years
gestational age of less than 14 weeks
vitamin D levels below 20 ng / ml
Exclusion criteria:
Fetal abnormalities
Abortion
زایمان قبل از 20 هفته
Lack of cooperation of the mother in receiving treatment
Kidney disorders in pregnant women
Blood pressure in pregnant women
Diabetes in pregnant women
Age
From 18 years old to 45 years old
Gender
Female
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
55
Actual sample size reached:
57
Randomization (investigator's opinion)
Randomized
Randomization description
Patients were randomly divided into three groups of 19 using random allocation software. From the first patient with inclusion criteria, treatment allocation was started based on randomization and all underwent the prescribed drug treatment.
Initially, the numbers 1 to 57 were written on 57 envelopes, respectively. Then, in each envelope, a sheet containing the code of the type of treatment of each patient, which is specified based on the random allocation software and determines the treatment of each patient, and the written consent form of the study participant was placed. After entering or identifying each patient in accordance with the criteria for entering an envelope, the numbers were selected in the order in which the type of treatment was specified in code.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Shahroud Azad University
Street address
7th sub. Third Alley. Shahrebani st.
City
Shahrood
Province
Semnan
Postal code
3616637333
Approval date
2021-01-13, 1399/10/24
Ethics committee reference number
IR.IAU.SHAHROOD.REC.1399.069
Health conditions studied
1
Description of health condition studied
Vitamin D deficiency
ICD-10 code
E55.0
ICD-10 code description
Rickets, active
Primary outcomes
1
Description
vitamin D insuffiency
Timepoint
Pregnant mother under 18 weeks
Method of measurement
evaluation of vit D blood serum
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Vitamin D administration at a dose of 2000
Category
Treatment - Drugs
2
Description
Intervention group: Vitamin D administration at a dose of 4000
Category
Treatment - Drugs
3
Description
Control group: Vitamin D administration at a dose of 1000
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Shahroud Bahar Hospital Clinic
Full name of responsible person
Dr Mina Kohbodi
Street address
Bahar Hospital, 22 Bahman St.
City
Shahrood
Province
Semnan
Postal code
3616637333
Phone
+98 58 3623 5480
Email
fatemeh.sadri1374@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shahroud University of Medical Sciences
Full name of responsible person
Dr. Behrooz Yahyaei
Street address
sub7, 3rd Alley, Shahrbani St.
City
Shahrood
Province
Semnan
Postal code
3616637333
Phone
+98 58 3623 5480
Email
fatmeh.sadri1374@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahroud University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Private
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
Shahroud University of Medical Sciences
Full name of responsible person
Mina Kohbodi
Position
Assistant professor
Latest degree
Specialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
7th sub, 3rd Alley, Shahrbani St.
City
Shahrood
Province
Semnan
Postal code
3616637333
Phone
+98 58 3623 5480
Email
fatmeh.sadri1374@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahroud University of Medical Sciences
Full name of responsible person
Mina Kohbodi
Position
Assistant professor
Latest degree
Specialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
7th sub, 3rd Alley, Shahrbani st.
City
Shahrood
Province
Semnan
Postal code
3616637333
Phone
+98 58 3623 5480
Email
fatmeh.sadri1374@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Shahroud University of Medical Sciences
Full name of responsible person
Mina Kohbodi
Position
Assistant professor
Latest degree
Specialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
7th sub, 3rd Alley, Shahrbani st.
City
Shahrood
Province
Semnan
Postal code
3616637333
Phone
+98 58 3623 5480
Email
fatmeh.sadri1374@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