NCT04944212

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. 1.Determine vitamin D levels among newborns born in north Jordan
  2. 2.Determine vitamin D levels among pregnant women in north Jordan
  3. 3.Study the association between maternal and infants levels of vitamin D
  4. 4.Explore the association between maternal and fetal characteristics and maternal and/or fetal vitamin D level
  5. 5.Study the effect of low fetal vitamin D on newborn anthropometry
  6. 6.Study the effect of maternal vitamin D supplement use during pregnancy in raising cord serum vitamin D levels

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
396

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Oct 2021

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 21, 2021

Completed
8 days until next milestone

First Posted

Study publicly available on registry

June 29, 2021

Completed
4 months until next milestone

Study Start

First participant enrolled

October 31, 2021

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 30, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 30, 2022

Completed
Last Updated

March 10, 2023

Status Verified

March 1, 2023

Enrollment Period

9 months

First QC Date

June 21, 2021

Last Update Submit

March 9, 2023

Conditions

Vitamin D Deficiency

Outcome Measures

Primary Outcomes (1)

  • 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 (1)

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

    5 months

Interventions

Measuring vitamin D serum level using ELIZADIAGNOSTIC_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.

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Pregnant women with singleton live fetuses who attended to labour ward

You may qualify if:

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

You may not qualify if:

  • women with multiple pregnancies or with dead fetuses

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

King Abdullah University Hospital

Irbid, Jordan

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

serum

MeSH Terms

Conditions

Vitamin D Deficiency

Condition Hierarchy (Ancestors)

AvitaminosisDeficiency DiseasesMalnutritionNutrition DisordersNutritional and Metabolic Diseases

Study Officials

  • Rawan A Obeidat, Dr

    Jordan University of Science and Technology

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 21, 2021

First Posted

June 29, 2021

Study Start

October 31, 2021

Primary Completion

July 30, 2022

Study Completion

July 30, 2022

Last Updated

March 10, 2023

Record last verified: 2023-03

Locations

JO(1)