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

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

Study Overview

• Status: Unknown
• Conditions: Vitamin D Intake in First Trimester and Incidence of Gestational Diabetes Recurrence
• Intervention / Treatment: Drug: Vitamin D

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 Type: Interventional
• Enrollment (Anticipated): 430
• Phase: Early Phase 1

Contacts and Locations

• Study Contact: Name: hany saad, Ass Prof; Phone Number: 01001817211; Email: hanysaad25280@gmail.com

Study Locations

• Egypt
  • Cairo, Egypt, 02
    • Recruiting
    • Kasr El Ainy

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 38 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

• pregnant women with history of gestational diabetes in previous pregnancies

Exclusion Criteria:

• multiple pregnancy
• pregnant patient with medical disorders

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
incidence of gestational diabetes recurrence	incidence of gestational diabetes recurrence	2 years

Collaborators and Investigators

• Sponsor: Kasr El Aini Hospital
• Investigators: Principal Investigator: ashraf mohsen, lecturer, Investigator

Study record dates

Study Major Dates

• Study Start (Actual): August 2, 2018
• Primary Completion (Anticipated): February 2, 2020
• Study Completion (Anticipated): April 2, 2020

Study Registration Dates

• First Submitted: October 6, 2018
• First Submitted That Met QC Criteria: October 6, 2018
• First Posted (Actual): October 9, 2018

Study Record Updates

• Last Update Posted (Actual): October 9, 2018
• Last Update Submitted That Met QC Criteria: October 6, 2018
• Last Verified: October 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Disease Attributes; Pregnancy Complications; Diabetes Mellitus; Recurrence; Diabetes, Gestational; Physiological Effects of Drugs; Micronutrients; Vitamins; Bone Density Conservation Agents; Vitamin D
• Other Study ID Numbers: assistant professor

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• 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