Prevalence of Vitamin D Deficiency in Pregnant Women and... | NCT04944212

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

NCT04944212

Sponsor

Jordan University of Science and Technology

Status

Completed

Last Update Posted

Mar 10, 2023Actual

Enrollment

396Actual

Phase

Not provided

Conditions

Vitamin D Deficiency

Interventions

Measuring vitamin D serum level using ELIZA

Countries

Jordan

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2023

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 31, 2021Actual

Primary Completion Date

Jul 30, 2022Actual

Completion Date

Jul 30, 2022Actual

First Submitted Date

Jun 21, 2021

First Submission Date that Met QC Criteria

Jun 21, 2021

First Posted Date

Jun 29, 2021Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 9, 2023

Last Update Posted Date

Mar 10, 2023Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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 :

Determine vitamin D levels among newborns born in north Jordan
Determine vitamin D levels among pregnant women in north Jordan
Study the association between maternal and infants levels of vitamin D
Explore the association between maternal and fetal characteristics and maternal and/or fetal vitamin D level
Study the effect of low fetal vitamin D on newborn anthropometry
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

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

396Actual

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
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.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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 Outcomes

Measure	Description	Time Frame
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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

women with multiple pregnancies or with dead fetuses

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Pregnant women with singleton live fetuses who attended to labour ward

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Rawan A Obeidat, Dr	Jordan University of Science and Technology	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
King Abdullah University Hospital		Irbid			Jordan

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
42344505	Derived	Obeidat RA, Sakee B, Alguzo S, Alshwayyat S, Altal OF, Rawashdeh H. Vitamin D status at birth among pregnant women and their newborns in Jordan: a cross-sectional study. Front Med (Lausanne). 2026 Jun 9;13:1864210. doi: 10.3389/fmed.2026.1864210. eCollection 2026.

ID	Term
D001361	Avitaminosis
D003677	Deficiency Diseases
D044342	Malnutrition
D009748	Nutrition Disorders