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Effect of Vitamin D Intake in Pregnancy to Prevent Recurrence of Gestational Diabetes

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ClinicalTrials.gov Identifier: NCT03701087
Recruitment Status : Unknown
Verified October 2018 by hadeer meshal, Kasr El Aini Hospital.
Recruitment status was:  Recruiting
First Posted : October 9, 2018
Last Update Posted : October 9, 2018
Sponsor:
Information provided by (Responsible Party):
hadeer meshal, Kasr El Aini Hospital

Study Description
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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

Condition or disease Intervention/treatment Phase
Vitamin D Intake in First Trimester and Incidence of Gestational Diabetes Recurrence Drug: Vitamin D Early Phase 1

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.
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 430 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Intervention Model Description: Effect of Vitamin D intake in pregnancy to prevent recurrence of gestational Diabetes
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Effect of Vitamin D Intake in Pregnancy to Prevent Recurrence of Gestational Diabetes
Actual Study Start Date : August 2, 2018
Estimated Primary Completion Date : February 2, 2020
Estimated Study Completion Date : April 2, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Pregnancy Vitamin D
Drug Information available for: Vitamin D

Arms and Interventions
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Arm Intervention/treatment
No Intervention: normal serum vitamin D
normal serum vitamin D
Experimental: low serum level of vitamin D
this arm will intake vitamin D 2800 IU daily
 Drug: Vitamin D
2800 IU daily till 26 weeks of pregnancy
Placebo Comparator: low serum vitamin D
this arm will intake placebo omega 3
 Drug: Vitamin D
2800 IU daily till 26 weeks of pregnancy


Outcome Measures
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Primary Outcome Measures :
  1. incidence of gestational diabetes recurrence [ Time Frame: 2 years ]
    incidence of gestational diabetes recurrence


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 38 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • pregnant women with history of gestational diabetes in previous pregnancies

Exclusion Criteria:

  • multiple pregnancy
  • pregnant patient with medical disorders
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03701087


Contacts
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Contact: hany saad, Ass Prof 01001817211 hanysaad25280@gmail.com
Contact: hadeer meshaal, Ass prof 01001435238 dr_hadeer@live.com

Locations
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Egypt
Kasr El Ainy Recruiting
Cairo, Egypt, 02
Contact: mohamed saad, lecturer    01244336666    msaad@scimitar.com   
Sponsors and Collaborators
Kasr El Aini Hospital
Investigators
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Principal Investigator: ashraf mohsen, lecturer Investigator
More Information
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Responsible Party: hadeer meshal, assistant professor, Kasr El Aini Hospital
ClinicalTrials.gov Identifier: NCT03701087    
Other Study ID Numbers: assistant professor
First Posted: October 9, 2018    Key Record Dates
Last Update Posted: October 9, 2018
Last Verified: October 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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
Additional relevant MeSH terms:
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Diabetes, Gestational
Diabetes Mellitus
Recurrence
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Disease Attributes
 Pathologic Processes
Pregnancy Complications
Vitamin D
Vitamins
Micronutrients
Physiological Effects of Drugs
Bone Density Conservation Agents