Comparing the effect of Therapeutic Doses of 200 and 50000 Units of Vitamin D on Serum 25(OH)D Levels in Pregnant Women Referred to Shahid Sayyad Shirazi Hospital of Gorgan between 2013-14
Objectives: This study was designed to compare the effects of therapeutic doses of 200 and 50,000 IU of vitamin D on 25 (OH) D serum levels in pregnant women.
Design: In this non-randomized clinical trial, study samples will be selected among pregnant women at gestational age of 12-16 weeks admitted to Sayyad Shirazi Hospital in Gorgan between2013-14.
Setting and Conduct: Eligible women will be enrolled after obtaining written informed consent and divided into two groups (A, B) and randomly will be placed 45 pregnant women in each group. First, a questionnaire containing demographic characteristics for pregnant mothers will be completed.
Inclusion criteria: gestational age 12-16 weeks based on first trimester ultrasound or accurate LMP; nulliparity; singleton pregnancy; vitamin D deficiency.
Exclusion criteria: incomplete treatment of supplements or impossible follow-up; a history of high-risk pregnancy; a history of parathyroid disease; hypocalecemia or hypercalcemia; underlying disease such as liver disease, renal disease; hypertension and malabsorption disorders; diabetes based on routine tests done during pregnancy.
Intervention: blood samples will be taken from pregnant women participating in the study to determine serum levels of 25 (OH) D. Then, group A will be treated with 200 IU of vitamin D supplements orally for 8 weeks and the women in group B will be treated with 50,000 IU of vitamin D supplements orally weekly for 8 weeks.
Main outcome measures: Pregnant women will be followed until delivery and on term delivery will be evaluated in terms of maternal outcomes such as gestational diabetes, preeclampsia and preterm labor and blood samples in order to reassess the serum levels of D (OH) 25 will be taken. The samples are also assessed to check for hypervitaminosis and safety of treatment with different doses of vitamin D. Collected data will be analyzed by SPSS-21 statistical software.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2014121120276N1
Registration date:2016-09-24, 1395/07/03
Registration timing:retrospective
Last update:
Update count:0
Registration date
2016-09-24, 1395/07/03
Registrant information
Name
Malihe Azadeh Rah
Name of organization / entity
Golestan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 17 3223 2269
Email address
m.azadehrah@goums.ac.ir
Recruitment status
Recruitment complete
Funding source
Gorgan Congenital Malformations Research Center of Golestan University of Medical Sciences
Expected recruitment start date
2014-04-21, 1393/02/01
Expected recruitment end date
2014-10-28, 1393/08/06
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparing the effect of Therapeutic Doses of 200 and 50000 Units of Vitamin D on Serum 25(OH)D Levels in Pregnant Women Referred to Shahid Sayyad Shirazi Hospital of Gorgan between 2013-14
Public title
Comparing the effect of Therapeutic Doses of 200 and 50000 Units of Vitamin D on Serum 25(OH)D Levels in Pregnant Women Referred to Shahid Sayyad Shirazi Hospital of Gorgan between 2013-14
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria included gestational age 12-16 weeks based on first trimester ultrasound or accurate LMP; nulliparity; singleton pregnancy; vitamin D deficiency. Exclusion criteria included incomplete treatment of supplements or impossible follow-up; a history of high-risk pregnancy; a history of parathyroid disease; hypocalecemia or hypercalcemia; underlying disease such as liver disease, renal disease; hypertension and malabsorption disorders (based on medical history or personal statements); diabetes (based on routine tests done during pregnancy).
Age
No age limit
Gender
Female
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
90
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
Ethic committee of Golestan University of Medical Sciences
Street address
Medical Faculty, Golestan University of Medical Sciences, Shast kola, Hirakan avenue, Gorgan, Iran
City
Gorgan
Postal code
49157-44545
Approval date
2014-04-21, 1393/02/01
Ethics committee reference number
1723059307201
Health conditions studied
1
Description of health condition studied
Vitamon D Deficiency
ICD-10 code
E55
ICD-10 code description
Vitamin D Dificiency
Primary outcomes
1
Description
Efficacy of different doses of vitamin D supplements and treatment of vitamin D deficiency in pregnant women
Timepoint
20 weeks after intervention
Method of measurement
Measurement of serum levels of 25 (OH) D in ng/dl
Secondary outcomes
1
Description
Prevention of maternal and neonatal complications of pregnancy
Timepoint
20 weeks after intervention
Method of measurement
Evaluation on term delivery in terms of complications
2
Description
Safety of treatment with vitamin D supplement
Timepoint
20 weeks after intervention
Method of measurement
Evaluation on term delivery in terms of hypervitaminosis and drug side effects
Intervention groups
1
Description
Group A will be treated with 200 IU of vitamin D supplements orally for 8 weeks.
Category
Treatment - Drugs
2
Description
The women in group B will be treated with 50,000 IU of vitamin D supplements orally weekly for 8 weeks