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Not yet recruiting NCT06111066

Vitamin D Levels in Neonatal Umbilical Cord Blood: Factors and Prognostic Analysis

Observational Vitamin d Deficiency

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
This is an observational study: the protocol does not assign a study treatment.
Who it may be relevant to
Registry conditions: Vitamin d Deficiency. Basic parameters: 1 Day — 5 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Overview

This study is a retrospective-prospective cohort study that investigates the factors influencing neonatal umbilical cord blood 25(OH)D levels, and the impact of exposure to low intrauterine 25(OH)D levels on neonatal prognosis. Newborns born in Sun Yat-sen Memorial Hospital of Sun Yat-sen University from August 2023 to August 2024 were selected. 2ml of umbilical cord blood was collected to test serum 25(OH)D levels. Based on the umbilical cord blood 25(OH)D levels, newborns were divided into three groups: vitamin D deficiency (\<30nmol/L), insufficiency (30\~50nmol/L), and sufficiency (\>50\~250nmol/L). Factors influencing neonatal vitamin D levels at birth were investigated by reviewing medical records, questionnaire collection, phone interviews, etc., collecting data on basic neonatal information, maternal information, complications during pregnancy, prenatal biochemical test results, medication history during pregnancy, lifestyle habits during pregnancy, and vitamin D supplementation status. Phone follow-ups on the health of the newborns during their hospital stay and at 1 month and 2 months after discharge were conducted to investigate the impact of exposure to low intrauterine 25(OH)D levels on neonatal prognosis, providing a theoretical basis for early intervention in high-risk pregnant women and early identification of high-risk groups with vitamin D deficiency or insufficiency among newborns. Miscarriages prevention is a major feature of our hospital's obstetrics department. Many pregnant women who are hospitalized and give birth at our hospital have a history of fetus protection. Choosing pregnant women and newborns from our hospital's obstetrics department as research subjects is conducive to exploring the impact of specific diseases and medication histories on neonatal vitamin D deficiency, which is an innovative aspect of this study.

Primary outcome measures

  • Maternal use of vitamin D supplements. [Time frame: 2024.01-2029.12]
  • Maternal sunlight exposure. [Time frame: 2024.01-2029.12]
Secondary outcome measures (3)
  • Maternal education status. [Time frame: 2024.01-2029.12]
  • Maternal weight. [Time frame: 2024.01-2029.12]
  • Pregnancy complications. [Time frame: 2024.01-2029.12]

Eligibility criteria

Inclusion criteria

  • Newborns delivered in Sun Yat-sen Memorial Hospital's obstetrics department.
  • Relatives agree to use clinically discarded specimens for research and have signed a consent form.

Exclusion criteria

  • Newborns with genetic mutations or congenital malformations.
  • Patients who died before discharge.
  • Pregnant women with conditions like chylous diarrhea, inflammatory bowel disease, and other chronic digestive system diseases.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

China · 1 center
  • Sun Yat-sen Memorial Hospital, Sun Yat-sen University — Guangzhou

Identifiers

NCT: NCT06111066 · SYSKY-2023-900-01

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗