Determination of the effects of monthly consumption of 100000 unit cholecalciferol during third trimester on plasma iPTH and 25 (OH) D3 of the mother and offspring in a group of pregnant Tehranian women and a matched control group.
The present study was designed to investigate the effects of monthly 100.000 IU of vitamin D on 25(OH) VitD and iPTH status in mothers and their newborns. Total of 50 pregnant women at 27 – 28 weeks of gestational age were randomly allocated into equal groups of intervention and placebo. All patients with sarcoidosis, tuberculosis, known liver and renal (cr> 2) disease, use of vitamin D and anticonvulsant drugs, were excluded. The patients were randomly allocated into one of two groups. One group received 100.000 IU vitamin D, one dose, monthly and others received the same capsules as placebo. 25(OH) Vit D, iPTH were measured at the beginning and the end of the study from the mother and cord blood. 25(OH)Vit D, iPTH were measured at the beginning and the end of the study from the mother and cord
blood.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201104306335N1
Registration date:2011-06-19, 1390/03/29
Registration timing:retrospective
Last update:
Update count:0
Registration date
2011-06-19, 1390/03/29
Registrant information
Name
Zary Sabet
Name of organization / entity
Shahed University
Country
Iran (Islamic Republic of)
Phone
+98 21 8896 6130
Email address
sabet@shahed.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for endocrine research, Shahid Beheshty University of Medical Sciences
Expected recruitment start date
2009-06-22, 1388/04/01
Expected recruitment end date
2010-06-22, 1389/04/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Determination of the effects of monthly consumption of 100000 unit cholecalciferol during third trimester on plasma iPTH and 25 (OH) D3 of the mother and offspring in a group of pregnant Tehranian women and a matched control group.
Public title
Effects of monthly consumption of 100000 unit cholecalciferol during last third trimester of pregnancy on plasma iPTH and 25 (OH) D3 of the mother and cord blood
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Pregnant women whose gestational age was between 27 to 28 weeks.
Exclusion criteria: Patients with systemic diseases such as renal (Cr > 2) and known liver disease, sarcoidosis, tuberculosis and receiving of vit D and anticonvulsant drugs.
Age
From 18 years old to 40 years old
Gender
Female
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
25
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Shahid Beheshti University of Medical Sciences, Endocrine Research Center
Street address
p.o.box: 1985717413, Endocrine Research Center, Shahid Beheshti University of Medical Sciences, NO 24, Parvaneh St, Yaman St,Chamran EXP way, Tehran, Iran.
City
Tehran
Postal code
1985717413
Approval date
2009-04-27, 1388/02/07
Ethics committee reference number
254EC
Health conditions studied
1
Description of health condition studied
Vit D
ICD-10 code
P00.4
ICD-10 code description
Fetus and newborn affected by maternal nutritional disorders
Primary outcomes
1
Description
25(0H)Vit D
Timepoint
3 months
Method of measurement
Laboratory methods( ng/ml )
2
Description
iPTH
Timepoint
3 months
Method of measurement
Laboratory methods(Pmol/l)
Secondary outcomes
empty
Intervention groups
1
Description
Cholecalciferol (Vitamin D3), capsule 50.000 IU, two capsules monthly for 3 months
Category
Treatment - Drugs
2
Description
Distilled water capsule, two capsules monthly for 3 months in last trimester of pregnancy
Vice chancellor for endocrine research, Shahid Beheshty University of Medical Sciences
Full name of responsible person
Saleh Zahedi Asl
Street address
p.o.box: 1985717413, Vice chancellor for endocrine research, Shahid Beheshty University of Medical Sciences, NO 24, Parvaneh St, Yaman St,Chamran EXP way, Tehran, Iran.
City
Tehran
Grant name
جاری و سایر منابع
Grant code / Reference number
123807
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for endocrine research, Shahid Beheshty University of Medical Sciences