A Comparative study of the effects of two Theraputic regimens for Vitamin D3 deficiency in the first trimester of pregnancy on Vitamin D3 levels in 24-28 weeks of gestation
The aim of the study: obtaining an overview of the effects of various therapies on vitamin D deficiency in pregnancy and choosing a suitable method for the treatment of pregnant women;Inclusioncriteria:Serum Vitamin D level is less than 30 ng/ml ; Exclusion criteria: the occurrence of any complication related to treatment ( nausea, vomiting, fatigue, weakness, headache, frequent urination, dry mouth ) ;Sampling method and sample size estimation : An in probable and available sampling method. For each treatment group, 100 patients and 200 people .Treatment will be done in two groups: Group A, Oral treatment of Vitamin D in the form of perl 50,000 units once a week for up to 10 weeks.The second group, Group B, includes oral treatment in the form of a Vitamin D3 tablet of 1000 units per day for up to 10 week. This study is intended for a period of one year.
General information
Acronym
Comparative dose of 1000 unite and 50000 unite Vitamin D
IRCT registration information
IRCT registration number:IRCT2016040527227N1
Registration date:2017-07-10, 1396/04/19
Registration timing:retrospective
Last update:
Update count:2
Registration date
2017-07-10, 1396/04/19
Registrant information
Name
Dr. Sedigheh Hantoshzadeh
Name of organization / entity
Tarbiat Modares University of Medical Science
Country
Iran (Islamic Republic of)
Phone
+98 21 6690 1515
Email address
farahnaz.rostami@modares.ac.ir
Recruitment status
Recruitment complete
Funding source
Tarbiat Modares of Medical Science
Expected recruitment start date
2016-07-20, 1395/04/30
Expected recruitment end date
2017-06-20, 1396/03/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
A Comparative study of the effects of two Theraputic regimens for Vitamin D3 deficiency in the first trimester of pregnancy on Vitamin D3 levels in 24-28 weeks of gestation
Public title
Theraputic regimens for Vitamin D3 deficiency
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusioncriteria:Serum Vitamin D level is less than 30 ng / ml ; Gestational age less than 14 weeks ; Age range18-42 years ; Not chronic disease, impaired absorption and metabolism of food ; Single pregnancy ;Not receiving any supplement except multivitamins to 400 unite Vit D3, folic acid, iron and calcium with 400 units Vit D3 ; Having Iranian nationalit ; Exclusion criteria:Unwillingness to continue participating in the study ; The occurrence of any complication related to treatment (nausea, vomiting, fatigue, weakness, headache, frequent urination, dry mouth) ; Do not use the correct medicine ; People who have special diets, including vegetarian diet, etc. Not taking omega-3
Age
From 18 years old to 42 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
200
Randomization (investigator's opinion)
Randomized
Randomization description
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
Tarbiat Modarres University of Medical Science
Street address
14115-111, Post box , , Intersection Al Ahmad Street , Shahid Chamran Highway, Tehran
City
Tehran
Postal code
Approval date
2016-07-10, 1395/04/20
Ethics committee reference number
IR.TMU.REC.1395.368
Health conditions studied
1
Description of health condition studied
Vitamine D deficiency
ICD-10 code
E55
ICD-10 code description
Vitamin D deficiency
Primary outcomes
1
Description
Study of Vitamin D levels
Timepoint
First Trimester and Second Trimester
Method of measurement
Blood Exam
Secondary outcomes
1
Description
Delete
Timepoint
Delete
Method of measurement
Delete
Intervention groups
1
Description
Group Therapy A: Oral Treatment of vitamin D perl 50,000 units once a week to 10 weeks
Category
Treatment - Drugs
2
Description
Group Therapy B, Oral Tretment of vitamin D
Tablet 1000 unite daily for 10 weeks
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Clinic of Gynecology and Obstetrics
Full name of responsible person
Farahnaz.Rostami
Street address
City
Tehrqan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tarbiat Modares University of Medical Science, Tehran
Full name of responsible person
Doctor Yaghob Fatollahi
Street address
14115-111, Post box, Intersection Al Ahmad Street, Shahid Chamran Highway , Tehran
City
Tehran
Grant name
52د/640
Grant code / Reference number
1273432
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tarbiat Modares University of Medical Science, Tehran
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
Tarbiat Modares University of Medicai Science
Full name of responsible person
Farahnaz Rostami
Position
Master / Student
Other areas of specialty/work
Street address
14115-111, Post box, Intersection Al Ahmad Street, Shahid Chamran Highway , Tehran
City
Tehran
Postal code
Phone
+98 21 6690 1515
Fax
Email
farahnaz.rostami@modares.ac.ir and frostami22@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tarbiat Modares University of Medical Science
Full name of responsible person
Doctor Sedigheh Hantoshzadeh
Position
Professor
Other areas of specialty/work
Street address
14115-111, Post box, Intersection Al Ahmad Street, Shahid Chamran Highway , Tehran
City
Tehran
Postal code
Phone
+98 21 6690 1515
Fax
Email
farahnaz.rostami@modares.ac.ir and frostami22@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Tarbiat Modares of Medical Science
Full name of responsible person
Doctor Lida Moghadambanaem
Position
Associate Professor
Other areas of specialty/work
Street address
14115-111, Post box, Intersection Al Ahmad street, Shahid Chamran highway , Tehran
City
Tehran
Postal code
1493675683
Phone
+98 21 8288 3857
Fax
Email
moghaddamb@modares.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)