Protocol summary
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Study aim
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The aim of this study is to determine the effects of vitamin D plus calcium co-supplementation on pregnancy outcomes in gestational diabetes.
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Design
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Parallel double-blind randomized controlled clinical trial.
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Settings and conduct
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60 patients with GDM among pregnant women of eligible and referred to maternity Clinic 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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Pregnant women aged 18-40 years diagnosed with GDM at 24-28 weeks' gestation will be included in this study. Exclusion criteria will be multiple gestation, major fetal anomalies, current illicit drug use, continuous daily Ca and/or vitamin D intake since last menstrual period, insulin-dependent diabetes, smoking and history of kidney stones.
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Intervention groups
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Patients will be assigned to receive either vitamin D plus calcium supplements (intervention group: n=30) or placebo (control group: n=30).
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Main outcome variables
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Fasting blood samples will be taken at baseline and after 6-wk intervention to measure serum vitamin D and calcium levels. Polyhydramnios will be diagnosed with sonographic estimation method at post-intervention. Infants' weight, length, head circumference, 5-min Apgar score and ponderal index will be measured.
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:
IRCT201407115623N23
Registration date:
2014-07-21, 1393/04/30
Registration timing:
retrospective
Last update:
2019-09-15, 1398/06/24
Update count:
1
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Registration date
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2014-07-21, 1393/04/30
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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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2014-02-04, 1392/11/15
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Expected recruitment end date
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2014-03-04, 1392/12/13
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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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Effect of vitamin D plus calcium co-supplementation on pregnancy outcomes in gestational diabetes
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Public title
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Effect of supplementation in treatment of gestational diabetes
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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 aged 18-40 years; diagnosed with GDM at 24-28 weeks' gestation
Exclusion criteria:
Multiple gestation,
Major fetal anomalies
Current illicit drug use
Continuous daily Ca and/or vitamin D intake since last menstrual period
Insulin-dependent diabetes
Smoking
History of kidney stones
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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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2
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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 weeks of gestation, subjects will be randomly divided into two groups to take either vitamin D plus calcium 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 the maternity clinics 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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2014-02-03, 1392/11/14
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Ethics committee reference number
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92-158-19
Health conditions studied
1
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Description of health condition studied
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Gestational diabetes
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ICD-10 code
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O24.9
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ICD-10 code description
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Diabetes mellitus in pregnancy, unspecified
Primary outcomes
1
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Description
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Newborn's weight
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Timepoint
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Delivery time
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Method of measurement
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Scale
Secondary outcomes
1
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Description
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Newborn's head circumference
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Timepoint
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Delivery time
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Method of measurement
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Tape
2
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Description
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Ponderal index
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Timepoint
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Delivery time
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Method of measurement
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Calculation
3
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Description
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Polyhydramnios
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Timepoint
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End-of-trial
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Method of measurement
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Sonographic
4
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Description
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Newborn's length
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Timepoint
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Delivery time
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Method of measurement
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Tape
5
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Description
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Newborn's bilirubin
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Timepoint
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Delivery time
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Method of measurement
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Enzymatic kit
6
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Description
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Apgar score
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Timepoint
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Delivery time
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Method of measurement
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Clinical observation
7
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Description
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Newborns' hypoglycemia
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Timepoint
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After delivery
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Method of measurement
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Enzymatic kit
8
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Description
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Preterm delivery
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Timepoint
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After delivery
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Method of measurement
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Medical record
9
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Description
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Maternal pre-eclampsia
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Timepoint
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After delivery
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Method of measurement
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Medical record
10
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Description
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Maternal hospitalization
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Timepoint
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After delivery
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Method of measurement
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Medical record
11
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Description
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Newborns' hospitalization
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Timepoint
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After delivery
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Method of measurement
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Medical record
Intervention groups
1
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Description
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Intervention group: Vitamin D3 capsule, 50000 IU, every 3 weeks for 6 weeks orally.
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Category
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Treatment - Drugs
2
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Description
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Intervention group: Calcium tablet, 500 mg, two times a day for 6 weeks orally.
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Category
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Treatment - Drugs
3
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Description
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Control group: Placebo capsule, every 3 weeks for 6 weeks orally.
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Category
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Treatment - Drugs
4
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Description
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Control group: Placebo tablet, two times a day for 6 weeks orally.
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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