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

Vitamin D Deficiency Clinical Trial

Official title:

Prevalence of Vitamin D Deficiency in Pregnant Women and Their Newborns and Their Association With Maternal and Newborns Characteristics

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04944212
• Other study ID #: 39/131/2020
• Status: Completed
• Start date: October 31, 2021
• Est. completion date: July 30, 2022

Study information

• Verified date: March 2023
• Source: Jordan University of Science and Technology
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 396
• Est. completion date: July 30, 2022
• Est. primary completion date: July 30, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

All pregnant women who attend to labour ward with singleton alive pregnancies Exclusion Criteria: women with multiple pregnancies or with dead fetuses

Related Conditions & MeSH terms

• Vitamin D Deficiency

Intervention

Diagnostic Test:
• Measuring vitamin D serum level using ELIZA
Venous blood will be obtained from pregnant women at the time of admission and from the umbilical cord veins of the newborns immediately after their delivery. The quantitative measurement of 25OHD in serum will be performed using ELIZA.

Locations

Country	Name	City	State
Jordan	King Abdullah University Hospital	Irbid

Sponsors (1)

Lead Sponsor	Collaborator
Jordan University of Science and Technology

Country where clinical trial is conducted

Jordan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Determine maternal and fetal vitamin D level among pregnant women and their newborns in north Jordan	Measurement of vitamin D using ELIZA	5 minutes
Secondary	Study the association between maternal and infants levels of vitamin D. Study factors that affect maternal and fetal vitamin D level	Both are measured using ELIZA	5 months