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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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CTRI |
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Last refreshed on:
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24 November 2021 |
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Main ID: |
CTRI/2014/12/005343 |
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Date of registration:
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31-12-2014 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Role of Vitamin D & calcium supplementation in gestational diabetic mothers
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Scientific title:
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Role of Vitamin D- Calcium supplementation on Metabolic profile and Oxidative stress in Gestational Diabetes Mellitus: An Open Labeled, Parallel Arm Randomised Control Trial |
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Date of first enrolment:
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15-01-2015 |
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Target sample size:
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64 |
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Recruitment status: |
Completed |
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URL:
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http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=10041 |
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Study type:
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Interventional |
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Study design:
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Randomized, Parallel Group, Active Controlled Trial
Method of generating randomization sequence:Computer generated randomization Method of allocation concealment:Sequentially numbered, sealed, opaque envelopes Blinding and masking:Open Label
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Phase:
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N/A
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Countries of recruitment
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India
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Contacts
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Name:
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Dr Mary Daniel
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Address:
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Department of Obstetrics & Gynaecology, Ganapathichettikulam
605014
Pondicherry, PONDICHERRY
India |
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Telephone:
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Email:
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marydaniel309@gmail.com |
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Affiliation:
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PONDICHERRY INSTITUTE OF MEDICAL SCIENCES |
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Name:
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Dr Tahmina
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Address:
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Department of Obstetrics & Gynaecology, Ganapathichettikulam
605014
Pondicherry, PONDICHERRY
India |
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Telephone:
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Email:
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marydaniel309@gmail.com |
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Affiliation:
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PONDICHERRY INSTITUTE OF MEDICAL SCIENCES |
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Key inclusion & exclusion criteria
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Inclusion criteria: Pregnant women with BMI 18-29.9, singleton pregnancy, Gestational diabetes controlled on diet alone
Exclusion criteria: Multiple pregnancy, GDM on insulin, medical complications
Age minimum:
Age maximum:
Gender:
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Health Condition(s) or Problem(s) studied
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Health Condition 1: O244- Gestational diabetes mellitus
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Intervention(s)
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Intervention1: Vit d 1000IU and calcium 1000mg: Supplementation for 6 weeks
Control Intervention1: Vitamin D 250IU and Calcium 500mg: Comparison of metabolic profile after supplementation with two different doses of vit d
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Primary Outcome(s)
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Vit d levels, metabolic profileTimepoint: Vit d levels, metabolic profile
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Secondary Outcome(s)
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Total GSH LEVELSTimepoint: After 6 weeks of supplementation
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Source(s) of Monetary Support
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Self
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Ethics review
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Status: Approved
Approval date: 30/09/2014
Contact:
PIMS Institute Ethics Committee
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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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30/06/2016 |
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URL:
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