Protocol summary
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Study aim
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Objective: This study is to determine the effects of vitamin D on metabolic profiles, hs-CRP and biomarkers of oxidative stress in pregnant women at risk for pre-eclampsia.
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Design
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Study design: Parallel double-blind (both patients and researchers) randomized controlled clinical trial.
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Settings and conduct
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Population and sample size: 60 pregnant women of eligible and referred to Taleghani and Emam Reza Clinics affiliated to Arak University of Medical Sciences, Arak, Iran in the study will be selected.
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Participants/Inclusion and exclusion criteria
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Inclusion criteria: Pregnant women primigravida and aged 18 to 40 years and at risk for pre-eclampsia will be included in this study. Exclusion criteria: Unable or unwilling to give written informed consent, Abnormal fetal anomaly scan and treated with warfarin
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Intervention groups
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Patients will be assigned to receive either 50000 IU vitamin D/each 2 weeks (intervention group: n=30) or placebo (control group: n=30).
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Main outcome variables
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Pre-eclampsia rate, low birth weight (LBW) (<2500 g), newborn's birth size and preterm delivery (<37 weeks) (primary outcomes) and other metabolic profiles (secondary outcome).
General information
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Reason for update
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT201410035623N27
Registration date:
2014-10-04, 1393/07/12
Registration timing:
retrospective
Last update:
2019-09-16, 1398/06/25
Update count:
1
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Registration date
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2014-10-04, 1393/07/12
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Registrant information
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Recruitment status
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Recruitment complete
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Funding source
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Arak University of Medical Sciences
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Expected recruitment start date
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2014-06-22, 1393/04/01
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Expected recruitment end date
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2014-07-23, 1393/05/01
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Actual recruitment start date
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empty
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Actual recruitment end date
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empty
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Trial completion date
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empty
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Scientific title
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Effects of vitamin D supplementation on metabolic profiles in pregnant women who are at risk of pre-eclampsia
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Public title
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Effect of supplementation in treatment of pregnancy complications
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Purpose
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Treatment
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Inclusion/Exclusion criteria
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Inclusion criteria:
Pregnant women primigravida
Aged 18-40 years old
At risk for pre-eclampsia
Exclusion criteria:
Unable or unwilling to give written informed consent
Abnormal fetal anomaly scan
Treated with warfarin
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Age
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From 18 years old to 40 years old
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Gender
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Female
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Phase
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3
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Groups that have been masked
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- Participant
- Investigator
- Outcome assessor
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Sample size
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Target sample size:
60
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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At study baseline and after stratification for pre-intervention BMI and age, subjects will be randomly divided into two groups to take either vitamin D supplements (n=30) or placebo (n=30). Randomization will be done by the use of computer-generated random numbers.
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Blinding (investigator's opinion)
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Double blinded
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Blinding description
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Randomization and allocation will be concealed from the researchers and participants until the final analyses are completed. Another person at gynecology clinic affiliated to Arak University of Medical Sciences, who is not involved in the trial and not aware of random sequences, will be assigned the participants to the numbered bottles of capsules.
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Placebo
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Used
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Assignment
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Parallel
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Other design features
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Ethics committees
1
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Ethics committee
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Approval date
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2013-08-26, 1392/06/04
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Ethics committee reference number
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92/151/2
Health conditions studied
1
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Description of health condition studied
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Pregnancy
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ICD-10 code
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O94
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ICD-10 code description
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Sequelae of complication of pregnancy, childbirth and the puerperium
Primary outcomes
1
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Description
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Pre-eclampsia rate
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Timepoint
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After delivery
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Method of measurement
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Medical record
2
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Description
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Low birth weight (LBW) (<2500 g)
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Timepoint
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After delivery
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Method of measurement
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Scale
3
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Description
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Newborn's birth size
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Timepoint
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After delivery
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Method of measurement
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Scale and tape
4
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Description
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Preterm delivery (<37 weeks)
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Timepoint
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After delivery
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Method of measurement
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Medical record
Secondary outcomes
1
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Description
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Insulin
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Timepoint
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Baseline and End-of-trial
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Method of measurement
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Eliza
2
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Description
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Nitric oxide
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Timepoint
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Baseline and End-of-trial
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Method of measurement
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Spectrophotometry
3
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Description
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hs-CRP
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Timepoint
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Baseline and End-of-trial
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Method of measurement
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Eliza
4
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Description
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Total antioxidant capacity
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Timepoint
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Baseline and End-of-trial
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Method of measurement
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Spectrophotometry
5
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Description
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Fasting plasma glucose
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Timepoint
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Baseline and End-of-trial
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Method of measurement
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Enzymatic
6
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Description
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Triglyceride
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Timepoint
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Baseline and End-of-trial
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Method of measurement
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Enzymatic
7
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Description
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Cholesterol
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Timepoint
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Baseline and End-of-trial
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Method of measurement
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Enzymatic
8
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Description
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HDL-cholesterol
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Timepoint
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Baseline and End-of-trial
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Method of measurement
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Enzymatic
9
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Description
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Blood pressures
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Timepoint
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Baseline and End-of-trial
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Method of measurement
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Manometer
Intervention groups
1
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Description
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Intervention group: Vitamin D pearl, 50000 IU, each two weeks for 12 weeks
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Category
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Treatment - Drugs
2
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Description
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Control group: Placebo pearl, each two weeks for 12 weeks
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Category
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Treatment - Drugs
1
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Sponsor
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Grant name
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Grant code / Reference number
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Is the source of funding the same sponsor organization/entity?
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Yes
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Title of funding source
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Arak University of Medical Sciences
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Proportion provided by this source
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100
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Public or private sector
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Public
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Domestic or foreign origin
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Domestic
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Category of foreign source of funding
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empty
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Country of origin
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Type of organization providing the funding
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Academic
Sharing plan
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Deidentified Individual Participant Data Set (IPD)
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Undecided - It is not yet known if there will be a plan to make this available
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Study Protocol
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Undecided - It is not yet known if there will be a plan to make this available
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Statistical Analysis Plan
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Undecided - It is not yet known if there will be a plan to make this available
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Informed Consent Form
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Undecided - It is not yet known if there will be a plan to make this available
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Clinical Study Report
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Undecided - It is not yet known if there will be a plan to make this available
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Analytic Code
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Undecided - It is not yet known if there will be a plan to make this available
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Data Dictionary
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Undecided - It is not yet known if there will be a plan to make this available