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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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IRCT |
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Last refreshed on:
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21 June 2021 |
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Main ID: |
IRCT201102135444N3 |
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Date of registration:
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2015-01-31 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Effect of supplementation in treatment of pregnancy complications
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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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Date of first enrolment:
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2014-09-06 |
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Target sample size:
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60 |
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Recruitment status: |
Complete |
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URL:
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http://en.irct.ir/trial/5844 |
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Study type:
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interventional |
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Study design:
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Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: 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, Blinding description: 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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Phase:
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3
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Countries of recruitment
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Iran (Islamic Republic of)
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Contacts
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Name:
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Dr Mansooreh Samimi
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Address:
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Ghotbe Ravandi Boulevard, Kashan
8115187159
Kashan
Iran (Islamic Republic of) |
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Telephone:
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+98 31 5544 7619 |
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Email:
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dr_samimi.2007@yahoo.com |
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Affiliation:
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Kashan University of Medical Sciences |
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Name:
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Dr Mansooreh Samimi
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Address:
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Ghotbe Ravandi Boulevard, Kashan
8115187159
Kashan
Iran (Islamic Republic of) |
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Telephone:
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+98 31 5544 7619 |
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Email:
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dr_samimi.2007@yahoo.com |
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Affiliation:
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Kashan University of Medical Sciences |
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Key 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
Age minimum:
18 years
Age maximum:
40 years
Gender:
Female
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Health Condition(s) or Problem(s) studied
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Pre-eclampsia.
Sequelae of complication of pregnancy, childbirth and the puerperium
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Intervention(s)
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Intervention 1: Intervention group: 50000 IU vitamin D pearl, each two weeks for 12 weeks + 1000 mg calcium tablet, daily for 12 weeks. Intervention 2: Control group: Vitamin D Placebo pearl, each two weeks for 12 weeks + Calcium Placebo tablet, daily for 12 weeks.
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Primary Outcome(s)
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Newborn's birth size. Timepoint: After delivery. Method of measurement: Scale and tape.
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Low birth weight (LBW) (<2500 g). Timepoint: After delivery. Method of measurement: Scale.
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Pre-eclampsia rate. Timepoint: After delivery. Method of measurement: Medical record.
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Preterm delivery (<37 weeks). Timepoint: After delivery. Method of measurement: Medical record.
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Secondary Outcome(s)
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Blood pressures. Timepoint: Baseline and End-of-trial. Method of measurement: Manometer.
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Fasting plasma glucose. Timepoint: Baseline and End-of-trial. Method of measurement: Enzymatic.
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HDL-cholesterol. Timepoint: Baseline and End-of-trial. Method of measurement: Enzymatic.
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Cholesterol. Timepoint: Baseline and End-of-trial. Method of measurement: Enzymatic.
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Nitric oxide. Timepoint: Baseline and End-of-trial. Method of measurement: Spectrophotometry.
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Total antioxidant capacity. Timepoint: Baseline and End-of-trial. Method of measurement: Spectrophotometry.
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High-sensitivity C-reactive protein. Timepoint: Baseline and End-of-trial. Method of measurement: Eliza.
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Insulin. Timepoint: Baseline and End-of-trial. Method of measurement: Eliza.
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Triglyceride. Timepoint: Baseline and End-of-trial. Method of measurement: Enzymatic.
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Source(s) of Monetary Support
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Vice chancellor for research, Kashan University of Medical Sciences
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Ethics review
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Status: Approved
Approval date: 31/03/2014
Contact:
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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