Effect of Vitamin D Intake in Pregnancy to Prevent Recurrence of Gestational Diabetes
Primary Purpose
Vitamin D Intake in First Trimester and Incidence of Gestational Diabetes Recurrence
Status
Unknown status
Phase
Early Phase 1
Locations
Egypt
Study Type
Interventional
Intervention
Vitamin D
Sponsored by
About this trial
This is an interventional prevention trial for Vitamin D Intake in First Trimester and Incidence of Gestational Diabetes Recurrence
Eligibility Criteria
Inclusion Criteria:
- pregnant women with history of gestational diabetes in previous pregnancies
Exclusion Criteria:
- multiple pregnancy
- pregnant patient with medical disorders
Sites / Locations
- Kasr El AinyRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
No Intervention
Experimental
Placebo Comparator
Arm Label
normal serum vitamin D
low serum level of vitamin D
low serum vitamin D
Arm Description
normal serum vitamin D
this arm will intake vitamin D 2800 IU daily
this arm will intake placebo omega 3
Outcomes
Primary Outcome Measures
incidence of gestational diabetes recurrence
incidence of gestational diabetes recurrence
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03701087
Brief Title
Effect of Vitamin D Intake in Pregnancy to Prevent Recurrence of Gestational Diabetes
Official Title
Effect of Vitamin D Intake in Pregnancy to Prevent Recurrence of Gestational Diabetes
Study Type
Interventional
2. Study Status
Record Verification Date
October 2018
Overall Recruitment Status
Unknown status
Study Start Date
August 2, 2018 (Actual)
Primary Completion Date
February 2, 2020 (Anticipated)
Study Completion Date
April 2, 2020 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Kasr El Aini Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
primary outcome is vitamin D intake in first trimester for pregnant women with history of gestational diabetes in previous pregnancies and incidence of gestational diabetes recurrence secondary outcome is effect of vitamin D intake on mode of delivery, apgar score and neonatal birth weight
Detailed Description
it is a prospective randomized controlled study to determined the effect of vitamin D supplementation in pregnancy in reducing the incidence of gestational diabetes recurrence. it will be conducted at the department of obstetrics and gynecology kasr el ainy hospital faculty of medicine Cairo university from August 2018 to April 2020. we include in our study 430 pregnant women who had history of gestational diabetes in their previous pregnancies. patients with multiple pregnancy or with any medical disorder are excluded from study. BMI will be calculated for each participant at the time of admission and glucose challenge test will be performed for all patients in the first trimester to exclude diabetic patients from the study then a blood sample is taken from all patients enrolled in the study to measure the vitamin D level by ELISA (after fasting 12 hours and not have a fatty dinner) the participants will be assigned to one of three main groups according to the serum 25 OH vitamin D level. pregnant women with normal vitamin D level assigned as group A, pregnant women with lower serum level of vitamin D (>20 nmol/L) randomly divided into two groups: group B and C. Group B will be given oral vitamin D 2800 units daily till 26 week pregnancy and group C will be given Omega 3 as placebo till 26 week pregnancy. incidence of gestational diabetes will be measured in 24-26 week pregnancy with OGTT and compared in the three groups. All patients will be followed up till delivery. Mode of delivery, Apgar score and neonatal birth weight will be recorded.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Vitamin D Intake in First Trimester and Incidence of Gestational Diabetes Recurrence
7. Study Design
Primary Purpose
Prevention
Study Phase
Early Phase 1
Interventional Study Model
Single Group Assignment
Model Description
Effect of Vitamin D intake in pregnancy to prevent recurrence of gestational Diabetes
Masking
None (Open Label)
Allocation
Randomized
Enrollment
430 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
normal serum vitamin D
Arm Type
No Intervention
Arm Description
normal serum vitamin D
Arm Title
low serum level of vitamin D
Arm Type
Experimental
Arm Description
this arm will intake vitamin D 2800 IU daily
Arm Title
low serum vitamin D
Arm Type
Placebo Comparator
Arm Description
this arm will intake placebo omega 3
Intervention Type
Drug
Intervention Name(s)
Vitamin D
Intervention Description
2800 IU daily till 26 weeks of pregnancy
Primary Outcome Measure Information:
Title
incidence of gestational diabetes recurrence
Description
incidence of gestational diabetes recurrence
Time Frame
2 years
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
38 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
pregnant women with history of gestational diabetes in previous pregnancies
Exclusion Criteria:
multiple pregnancy
pregnant patient with medical disorders
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
hany saad, Ass Prof
Phone
01001817211
Email
hanysaad25280@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
hadeer meshaal, Ass prof
Phone
01001435238
Email
dr_hadeer@live.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
ashraf mohsen, lecturer
Organizational Affiliation
Investigator
Official's Role
Principal Investigator
Facility Information:
Facility Name
Kasr El Ainy
City
Cairo
ZIP/Postal Code
02
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
mohamed saad, lecturer
Phone
01244336666
Email
msaad@scimitar.com
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Effect of Vitamin D Intake in Pregnancy to Prevent Recurrence of Gestational Diabetes
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