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The effect of Vitamin D supplementation on blood pressure, bone parameters, lipid profile, liver enzymes, glycemic and hematopoietic indices in pregnant women with vitamin D deficiency

Protocol summary

Summary
To determine the effect of Vitamin D supplementation on blood pressure, bone parameters, lipid profile, liver enzymes, glycemic and hematopoietic indices in pregnant women with vitamin D deficiency .It is a clinical trial study ( before and after ). The study population are 30 pregnant women with vitamin D deficiency. In the first stage of Intervention: to give a 50000 Units of Vitamin D weekly for 12 weeks. In the second stage of intervention:to give a 50000 Units of Vitamin D monthly for 3 months. In three steps, before and after the first stage of Intervention and second stage of intervention blood pressure systolic and diastolic serum 25OHD, Calcium,Phosphorus, Magnesium, PTH, Alkaline phosphatase,Aspartate aminotransferase, Alanine aminotransferase, low density Lipoprotein, high density Lipoprotein cholesterol, triglycerides, FBS, glycosylated hemoglobin, fasting insulin, insulin resistance, ferritin, transferrin saturation, iron, TIBC, RBC, MCH, MCHC, HCT, Hb MCV, will be measured.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2014091619162N5
Registration date: 2015-03-26, 1394/01/06
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2015-03-26, 1394/01/06
Registrant information
Name
Maryam Taghdir
Name of organization / entity
Baqiyatallah University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 8804 0153
Email address
mtaghdir@bums.ac.ir
Recruitment status
Recruitment complete
Funding source
Baqiyatallah University of Medical Science
Expected recruitment start date
2014-12-22, 1393/10/01
Expected recruitment end date
2015-08-23, 1394/06/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of Vitamin D supplementation on blood pressure, bone parameters, lipid profile, liver enzymes, glycemic and hematopoietic indices in pregnant women with vitamin D deficiency
Public title
The effect of Vitamin D3 supplementation on blood pressure, bone parameters, lipid profile, liver enzymes, glycemic and hematopoietic indices in pregnant women with Vitamin D deficiency
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: women between 14-12 weeks of pregnancy; the level of serum 25OHD<20ng /ml; with a body mass index less than 30 Kg/m2; age less than 35 years; normal blood pressure; not having any systemic disease such as Cardiovascular disease; renal disease, diabetes, heart disease, liver disease; In the past 6 months did not receive vitamin D supplements; not to have calcium deficiency; not smoking; and alcohol consumption; Not taking anticonvulsant drugs or any other drugs; singleton pregnancy; first pregnancy or 3 years spacing between two pregnancy. Exclusion criteria: presence of any systemic disease.
Age
From 18 years old to 35 years old
Gender
Female
Phase
3
Groups that have been masked
No information
Sample size
Target sample size: 30
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Baqiyatallah University of Medical Sciences
Street address
Baqiyatallah University of Medical Sciences, South Sheikh Bahaei street, Mollasadra Avenue, Tehran, Iran
City
Tehran
Postal code
Approval date
2014-11-22, 1393/09/01
Ethics committee reference number
5904

Health conditions studied

1

Description of health condition studied
Vitamin D Deficiency
ICD-10 code
E55.9
ICD-10 code description
Vitamin D Deficiency, unspecified

Primary outcomes

1

Description
Magnesium
Timepoint
Three times: 1) before supplementation 2)After weekly supplementation for 12 weeks 3) Delivery time
Method of measurement
In milligrams per deciliter and by autoanalyzer

2

Description
Phosphor
Timepoint
Three times: 1) before supplementation 2)After weekly supplementation for 12 weeks 3) Delivery time
Method of measurement
In milligrams per deciliter and by autoanalyzer

3

Description
Calcium
Timepoint
Three times: 1) before supplementation 2)After weekly supplementation for 12 weeks 3) Delivery time
Method of measurement
In milligrams per deciliter and by autoanalyzer

4

Description
PTH
Timepoint
Three times: 1) before supplementation 2)After weekly supplementation for 12 weeks 3) Delivery time
Method of measurement
In milligrams per deciliter and by autoanalyzer

5

Description
Alkaline Phosphatase
Timepoint
Three times: 1) before supplementation 2)After weekly supplementation for 12 weeks 3) Delivery time
Method of measurement
In milligrams per deciliter and by autoanalyzer

6

Description
25OHD Serum
Timepoint
Three times: 1) before supplementation 2)After weekly supplementation for 12 weeks 3) Delivery time
Method of measurement
Units are ng / ml using 25OHD ALIZA

7

Description
Diastolic Blood Pressure
Timepoint
Three times: 1) before supplementation 2)After weekly supplementation for 12 weeks 3) Delivery time
Method of measurement
In millimeters of mercury sphygmomanometer

8

Description
Systole Blood Pressure
Timepoint
Three times: 1) before supplementation 2)After weekly supplementation for 12 weeks 3) Delivery time
Method of measurement
In millimeters of mercury sphygmomanometer

9

Description
FBS
Timepoint
Three times: 1) before supplementation 2)After weekly supplementation for 12 weeks 3) Delivery time
Method of measurement
Units are mg / dl using autoanalyzer

10

Description
Insulin
Timepoint
Three times: 1) before supplementation 2)After weekly supplementation for 12 weeks 3) Delivery time
Method of measurement
Units are μIU / ml using insulin kits

11

Description
Insulin Resistance
Timepoint
Three times: 1) before supplementation 2)After weekly supplementation for 12 weeks 3) Delivery time
Method of measurement
Using the index, HOMA-ir

12

Description
HbA1c
Timepoint
Three times: 1) before supplementation 2)After weekly supplementation for 12 weeks 3) Delivery time
Method of measurement
Units are % using HbA1c kits

13

Description
Ferritin
Timepoint
Three times: 1) before supplementation 2)After weekly supplementation for 12 weeks 3) Delivery time
Method of measurement
Units are ng / ml ferritin kits

14

Description
Transferrin Saturation
Timepoint
Three times: 1) before supplementation 2)After weekly supplementation for 12 weeks 3) Delivery time
Method of measurement
Units are % using serum Iron/TIBC x 100

15

Description
Serum Iron
Timepoint
Three times: 1) before supplementation 2)After weekly supplementation for 12 weeks 3) Delivery time
Method of measurement
Units are μg / dl using iron kits

16

Description
TIBC
Timepoint
Three times: 1) before supplementation 2)After weekly supplementation for 12 weeks 3) Delivery time
Method of measurement
Units are μg / dl using TIBC kits

17

Description
RBC
Timepoint
Three times: 1) before supplementation 2)After weekly supplementation for 12 weeks 3) Delivery time
Method of measurement
Units are μL using cell counter

18

Description
Hb
Timepoint
Three times: 1) before supplementation 2)After weekly supplementation for 12 weeks 3) Delivery time
Method of measurement
Units are g/dl using cell counter

19

Description
HCT
Timepoint
Three times: 1) before supplementation 2)After weekly supplementation for 12 weeks 3) Delivery time
Method of measurement
Units are % using cell counter

20

Description
MCV
Timepoint
Three times: 1) before supplementation 2)After weekly supplementation for 12 weeks 3) Delivery time
Method of measurement
Units are fL using cell counter

21

Description
MCH
Timepoint
Three times: 1) before supplementation 2)After weekly supplementation for 12 weeks 3) Delivery time
Method of measurement
Units are Pg using cell counter

22

Description
MCHC
Timepoint
Three times: 1) before supplementation 2)After weekly supplementation for 12 weeks 3) Delivery time
Method of measurement
Units are g/dl using cell counter

23

Description
Cholesterol
Timepoint
Three times:1)Befor of supplementation 2)after weekly supplementation for 12 week3) delivery time
Method of measurement
In mg/dl and by autoanalyzer

24

Description
Triglycerides
Timepoint
Three times:1)Befor of supplementation 2)after weekly supplementation for 12 week3) delivery time
Method of measurement
In mg/dl and by autoanalyzer

25

Description
Low Density Lipoprotein
Timepoint
Three times:1)Befor of supplementation 2)after weekly supplementation for 12 week3) delivery time
Method of measurement
In mg/dl and by auto analyzer

26

Description
High Density Lipoprotein
Timepoint
Three times:1)Befor of supplementation 2)after weekly supplementation for 12 week3) delivery time
Method of measurement
In mg/dl and by autoanalyzer

27

Description
ALanin Amino Teransferase
Timepoint
Three times:1)Befor of supplementation 2)after weekly supplementation for 12 week3) delivery time
Method of measurement
in Unit per liter and by Autoanalyser

28

Description
Aspartat Amino Teransferase
Timepoint
Three times:1)Befor of supplementation 2)after weekly supplementation for 12 week3) delivery time
Method of measurement
In unit per liter and by autoanalyzer

Secondary outcomes

empty

Intervention groups

1

Description
In the first stage of Intervention: to give a 50000 Units of Vitamin D weekly for 12 weeks. In the second stage of intervention:to give a 50000 Units of Vitamin D monthly for 3 months.
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Gyncology & Obstetrics Clinic of Baqiyatallah Hospital
Full name of responsible person
Dr.Seyedeh Razieh Hashemi
Street address
Gyncology & Obstetrics Clinic, Baghiatallah Hospital, Mollasadra Avenue, Tehran, Iran
City
Tehran

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Baqiyatallah University of Medical Sciences
Full name of responsible person
Maryam Taghdir
Street address
School of Public Health, Baqiyatallah University of Medical Sciences, Barazil street, South Sheikh Bahae street, Mollasadrai Avenue, Tehran, Iran
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Baqiyatallah University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty

Person responsible for general inquiries

Contact
Name of organization / entity
Baqiyatallah University of Medical Sciences
Full name of responsible person
Tahereh Babashamsi, Saeideh Nahani, Simindokht Esmaeilzadeh
Position
MSc Student
Other areas of specialty/work
Street address
School of Public Health, Baqiyatallah University of Medical Sciences, Barazil street, South Sheikh Bahaei street, Mollasadra Avenue, Tehran, Iran
City
Tehran
Postal code
Phone
00982144704033 00982166686697 00982177872648
Fax
Email
babashamsi@gmail.com ssaeideh1@yahoo.com simin747@gmail.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Baqiyatallah University of Medical Sciences
Full name of responsible person
Maryam Taghdir
Position
Instructor
Other areas of specialty/work
Street address
School of Public Health, Baqiyatallah University of Medical Sciences, Barazil street, South Sheikh Bahaei street, Mollasdra Avenue, Tehran, Iran
City
Tehran
Postal code
Phone
+98 21 8804 0153
Fax
Email
mtaghdir@bmsu.ac.ir mtaghdir@gmail
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Baqiyatallah University of Medical Sciences
Full name of responsible person
Tahereh Babashamsi, Saeideh Nahani, Simindokht Esmaeilzadeh
Position
MSc Students
Other areas of specialty/work
Street address
School of Public Health, Baqiyatallah University of Medical Sciences, Barazil street, South Sheikh Bahaei street, Mollasadra Avenue, Tehran, Iran
City
Tehran
Postal code
Phone
00982144704033 00982166686697 00982177872648
Fax
Email
babashamsi@gmail.com ssaeideh1@yahoo.com simin747@gmail.com
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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