Clinical Trial on the Evaluation of Calcium and Vitamin D in the Cord Serum of Neonates, Whose Mothers Were Under Vitamin D Treatment During Their Pregnancy
The population of this study includes all neonates of pregnant women who are in the age of 16 to 35 years old and among 14 to 16 weeks of pregnancy referred to Amiral-mo'menin Hospital in 1393 to take prenatal care. Two groups of 90 pregnant mothers which determined with vitamin D deficiency, concerning inclusion and exclusion criteria, were selected and named intervention and control groups. Intervention group was given 8 doses of vitamin D pearls every two weeks; each dose contains 50000 units, plus multi prenatal tablet including 400 units of vitamin D, every day. Also, the control group only received the multi prenatal tablet, every day.
The methods which were used in collecting data are demographic questionnaire and recording data check-lists which were filled with laboratory assessments. Additionally, this is a single blinded study that include just research groups. In order to collect data, three milliliters of cord blood in related tubes were collected, in the time of childbirth. Then, they were transferred to the laboratory of Semnan Amir al-mo'menin Hospital and the level of serum 25-OH vitamin D and calcium were evaluated with England Euroimmeun and Semnan Rezateb kits using ELISA method, respectively.
General information
Acronym
-
IRCT registration information
IRCT registration number:IRCT2015041321736N1
Registration date:2016-01-25, 1394/11/05
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2016-01-25, 1394/11/05
Registrant information
Name
Shamsollah Nooripour
Name of organization / entity
Amiralmomenin Hospital
Country
Iran (Islamic Republic of)
Phone
+98 23 3346 0077
Email address
amir.hospital@semums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Semnan University of Medical Science
Expected recruitment start date
2015-03-21, 1394/01/01
Expected recruitment end date
2016-03-20, 1395/01/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Clinical Trial on the Evaluation of Calcium and Vitamin D in the Cord Serum of Neonates, Whose Mothers Were Under Vitamin D Treatment During Their Pregnancy
Public title
Evaluation of Calcium and Vitamin D in Neonates
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: pregnant mothers with vitamin D deficiency; age of 16-35 years; singleton pregnancy; gestational age of among 8 to 12 weeks which is confirmed by LMP or sonography; BMI lower than thirty at the first prenatal visit; no history of gestational diabetes; not suffering from glycosuria, fasting blood sugar less than 92; no precedent of polyhydramnios; no history of macrosomia (weight of 4 kg) in children; with no history of stillbirth or a baby with malformations; non-smoking participants.
Exclusion criteria: patients with diabetes type one or two; those with hypertension; patients with parathyroid disease and other metabolic diseases; people with untreated thyroid disease and liver or kidney deficiency; patients taking anti-epileptic drugs and corticosteroids; and people with a particular disease. Also, those who refuse consent for participating in this study, will be excluded.
Age
From 16 years old to 35 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
180
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
-
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethic committee of Semnan University of Medical Science
Street address
5th kilometers of Damghan road, Semnan- Iran.
City
semnan
Postal code
35198-99951
Approval date
2015-03-17, 1393/12/26
Ethics committee reference number
93.584644
Health conditions studied
1
Description of health condition studied
vitamin D deficioncy
ICD-10 code
E55.9
ICD-10 code description
Vitamin D deficiency, unspecified
Primary outcomes
1
Description
25oH vitamin D3
Timepoint
daily
Method of measurement
mg/dl
2
Description
Calcium
Timepoint
daily
Method of measurement
mg/dl
Secondary outcomes
1
Description
-
Timepoint
-
Method of measurement
-
Intervention groups
1
Description
injection of 50000 units of vitamin D, eight doses every two weeks
Category
Treatment - Drugs
2
Description
In the control group, multi natal tab including 400 units of vitamin D was taken every day.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Amir al-momenin hospital
Full name of responsible person
Dr. Nouripour
Street address
Management office of Amir al-momenin Hospital, Imam Hossein Square, Semnan, Iran.
City
Semnan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice Chancellor of Semnan University of medical science
Full name of responsible person
Dr. Nouripour
Street address
Management office of Amir al-mo'menin Hospital, Imam Hossein Square, Semnan- Iran.
City
Semnan
Grant name
-
Grant code / Reference number
-
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice Chancellor of Semnan University of medical science
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
Amir al-mo'menin Hospital
Full name of responsible person
Dr. Shamsollah Nouripour
Position
Advisor professor, neonatalogist
Other areas of specialty/work
Street address
Amir al-mo'menin Hospital, Imam Hossein Square, Semnan- Iran.
City
Semnan
Postal code
Phone
+98 23 3346 0099
Fax
-
Email
sh.noripour@yahoo.com
Web page address
amir.hospital@semums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Semnan University of Medical Science
Full name of responsible person
Dr. Nouripour
Position
neonatalogist
Other areas of specialty/work
Street address
Management office of Amir al-mo'menin Hospital, Imam Hossein Square, Semnan- Iran.
City
Semnan
Postal code
Phone
+98 23 3346 0099
Fax
-
Email
sh.noripour@yahoo.com
Web page address
amir.hospital@semums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Semnan University of Medical Science
Full name of responsible person
Dr. Nouripour
Position
neonatalogist
Other areas of specialty/work
Street address
Management office of Amir al-mo'menin Hospital, Imam Hossein Square, Semnan- Iran.
City
Semnan
Postal code
-
Phone
+98 23 3346 0099
Fax
-
Email
sh.noripour@yahoo.com
Web page address
amir.hospital@semums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)