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OpenTrials
Completed

NCT Number: NCT04944212

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

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

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Key information

Sex eligibility

All sexes

Study type

Observational

Primary location

King Abdullah University Hospital

Irbid, Jordan

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

women with multiple pregnancies or with dead fetuses

Treatment and study plan

Measuring vitamin D serum level using ELIZA

Diagnostic Test

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.

Primary outcomes

  1. Determine maternal and fetal vitamin D level among pregnant women and their newborns in north Jordan

    Time frame: 5 minutes

    Measurement of vitamin D using ELIZA

Secondary outcomes

  1. Study the association between maternal and infants levels of vitamin D. Study factors that affect maternal and fetal vitamin D level

    Time frame: 5 months

    Both are measured using ELIZA

Sponsors and collaborators

Lead sponsor

Jordan University of Science and Technology

Other

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Jun 29, 2021
Registry last updated
Mar 10, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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