Protocol summary
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Study aim
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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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Sixty pregnant women of eligible and referred to Clinic affiliated to Kashan University of Medical Sciences, Kashan, Iran in the study will be selected.
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Participants/Inclusion and exclusion criteria
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Inclusion criteria: Primigravida pregnant women; aged 18–40 years old; at risk for pre-eclampsia; lived approximately 20 km or less from the clinic and hospital. Exclusion criteria: Hypertension; renal diseases; gestational diabetes mellitus (GDM); abnormal foetal anomaly scan
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Intervention groups
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Patients will be assigned to receive either 50000 IU vitamin D/each 2 weeks and 1000 mg calcium daily (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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Due to an error, the request for an update in our website has conducted after paper published. However, the revisions were accordance with either the original approved proposal or with coordination with Vice Chancellor of Research at the University.
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT201102135444N3
Registration date:
2015-01-31, 1393/11/11
Registration timing:
retrospective
Last update:
2021-05-27, 1400/03/06
Update count:
1
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Registration date
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2015-01-31, 1393/11/11
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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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Vice chancellor for research, Kashan University of Medical Sciences
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Expected recruitment start date
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2014-09-06, 1393/06/15
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Expected recruitment end date
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2014-10-06, 1393/07/14
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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 calcium and vitamin D co-supplementation on pre-elampsia parameters, metabolic status and biomarkers of oxidative stress in pregnant women at risk for 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:
Primigravida pregnant women
Aged 18–40 years old
At risk for pre-eclampsia
Lived approximately 20 km or less from the clinic and hospital
Exclusion criteria:
Hypertension
Renal diseases
Gestational diabetes mellitus (GDM)
Abnormal foetal anomaly scan
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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
- Care provider
- Investigator
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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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Randomization and allocation will be concealed from the researchers and participants until the final analyses are completed. Another person at the Clinic who is not involved in the trial and not aware of random sequences will be allocated the numbered bottles of capsules to participants. Supplements and placebo are in the same packaging at the pharmaceutical company. Only the code is written on the packages. Patients and researcher do not know the type of drug and after analyzing the data, packet codes are decoded.
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Blinding (investigator's opinion)
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Double blinded
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Blinding description
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Patients will be randomly assigned into two groups. A randomization list will be generated from 1 to 60 by a random number generator (https://stattrek.com/statistics/random-number-generator.aspx) and patients will be randomly assigned into each intervention group by their numbers.
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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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2014-03-31, 1393/01/11
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Ethics committee reference number
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196/1/5/29/پ
Health conditions studied
1
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Description of health condition studied
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Pre-eclampsia
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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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High-sensitivity C-reactive protein
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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: 50000 IU vitamin D pearl, each two weeks for 12 weeks + 1000 mg calcium tablet, daily 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: Vitamin D Placebo pearl, each two weeks for 12 weeks + Calcium Placebo tablet, daily 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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Vice chancellor for research, Kashan 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