Prevalence of Vitamin D Deficiency in Pregnant Women and Their Fetus in North Jordan

Completed

• Conditions: Vitamin D Deficiency

• Registration Number: NCT04944212
• Lead Sponsor: Jordan University of Science and Technology

Brief Summary

In Jordan, there are few data about the prevalence of hypovitaminosis D in pregnant women and their newborns and factors that affect their levels. Hence, in this study, investigators will :

1. Determine vitamin D levels among newborns born in north Jordan

2. Determine vitamin D levels among pregnant women in north Jordan

3. Study the association between maternal and infants levels of vitamin D

4. Explore the association between maternal and fetal characteristics and maternal and/or fetal vitamin D level

5. Study the effect of low fetal vitamin D on newborn anthropometry

6. Study the effect of maternal vitamin D supplement use during pregnancy in raising cord serum vitamin D levels

Detailed Description

This is a cross-sectional study that will be carried out at King Abdullah University Hospital (KAUH). After being approved by the Institutional Review Board (IRB) of KAUH, written informed consents will be obtained from the newborns' mothers.

5 ml of venous blood will be obtained from pregnant women at the time of admission and 3 ml of venous blood will be obtained from the umbilical cord veins of the newborns immediately after their delivery. The quantitative measurement of 25OHD in serum will be performed using ELIZA.

Investigators will determine the means, medians and standard deviations of 25OHD levels among pregnant women and infants in Jordan. In addition, investigators will study the association between maternal and infants levels of 25OHD. Moreover, investigators will investigate the association between maternal level of vitamin D and elective maternal variables including vitamin D supplements during and before pregnancy, sun exposure, age, weight, parity, BMI, \& maternal medical problems. In addition, investigators will study the effect of low fetal vitamin D on newborn anthropometry. Finally, investigators will study the effect of maternal vitamin D supplements use during pregnancy in raising cord serum vitamin D levels

Study Timeline

• Study First Submitted: 2021-06-21
• Study First Submitted QC: 2021-06-21
• Study First Posted: 2021-06-29
• Study Start: 2021-10-31
• Primary Completion: 2022-07-30
• Study Completion: 2022-07-30
• Status Verified: 2023-03
• Last Update Submitted: 2023-03-09
• Last Update Posted: 2023-03-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 396

Inclusion Criteria

All pregnant women who attend to labour ward with singleton alive pregnancies

Exclusion Criteria

women with multiple pregnancies or with dead fetuses

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Determine maternal and fetal vitamin D level among pregnant women and their newborns in north Jordan	5 minutes	Measurement of vitamin D using ELIZA

Secondary Outcome Measures

Name	Time	Method
Study the association between maternal and infants levels of vitamin D. Study factors that affect maternal and fetal vitamin D level	5 months	Both are measured using ELIZA

Trial Locations

Locations (1)

King Abdullah University Hospital; 🇯🇴 Irbid, Jordan