Protocol summary
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Study aim
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The aim of this study is to determine the effects of calcium and vitamin D co-supplementation on insulin resistance, inflammatory factor and biomarkers of oxidative stress in gestational diabetes.
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Design
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This study is a randomized double-blind placebo-controlled trial.
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Settings and conduct
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56 patients with GDM among pregnant women of eligible and referred to maternity clinics 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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Pregnant women aged 18-40 years diagnosed with GDM at 24-28 weeks' gestation will be included in this study. Subjects with premature preterm rupture of membrane (PPROM), placenta abruption, pre-eclampsia, eclampsia, chronic hypertension, hypothyroidism, urinary tract infection, smokers and those with kidney or liver diseases or those taking estrogen therapy, those who required commencing insulin therapy during intervention and stressful life conditions will be excluded.
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Intervention groups
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Patients will be assigned to receive either calcium and vitamin D supplements (intervention group) or placebo (control group).
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Main outcome variables
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Baseline and End-of-trial fasting plasma glucose (FPG), serum insulin, insulin resistance, lipid profiles, inflammatory factors and biomarkers of oxidative stress 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:
IRCT201311205623N11
Registration date:
2013-12-01, 1392/09/10
Registration timing:
registered_while_recruiting
Last update:
2019-09-13, 1398/06/22
Update count:
1
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Registration date
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2013-12-01, 1392/09/10
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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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Kashan University of Medical Sciences
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Expected recruitment start date
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2013-11-20, 1392/08/29
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Expected recruitment end date
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2014-01-19, 1392/10/29
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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 calcium and vitamin D co-supplementation on insulin resistance and inflammatory factors in women with gestational diabetes
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Public title
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Effect of calcium and vitamin D 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:
Subjects with premature preterm rupture of membrane
Placenta abruption
Pre-eclampsia
Eclampsia
Chronic hypertension
Hypothyroidism
Urinary tract infection
Smoking
Those with kidney or liver diseases
Those taking estrogen therapy
Stressful life conditions
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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:
56
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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, after balance randomization, subjects will be randomly divided into two groups to take either calcium and vitamin D co-supplementation (n = 28) or placebo (n = 28). 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 Kashan 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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2013-11-20, 1392/08/29
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Ethics committee reference number
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3460/1/5/29/P
Health conditions studied
1
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Description of health condition studied
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Gestational diabetes mellitus
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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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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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Elisa kit
Secondary outcomes
1
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Description
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Insulin resistance
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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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Calculation using HOMA formula
2
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Description
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Total 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 kit
3
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Description
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Triglycerides
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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 kit
4
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Description
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HDL
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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 kit
5
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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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Elisa kit
6
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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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t Spectrophotometry
7
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Description
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Glutathione
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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
8
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Description
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Malondialdehyde
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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
9
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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
10
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Description
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Fasting blood sugar
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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 kit
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.
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
2
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Description
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Control group: Placebo capsule, every 3 weeks for 6 weeks orally.
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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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