GraviD-child Follow-up of the Children´s Health, Growth and Development Within the GraviD-study

NCT05228925 | Completed

• 1 other identifier: 2018-00441
• Study Type: observational
• Target: 172
• Locations: 1 country
• Sites: 1

Brief Summary

GraviD is a multi-ethnic population-based pregnancy cohort. Pregnant women were invited to participate in the GraviD study when registering for antenatal care in parts of the region of Västra Götaland in Sweden in 2013-2014. All women registering for antenatal care were eligible for inclusion, as long as the pregnancy had not exceeded 16 gestational weeks. In total, 2125 pregnant women were recruited in gestational week 12 during two time-periods; fall 2013 and spring 2014. Blood sampling was performed in gestational week \<17 and again at gestational week \>31 by midwifes. After delivery, the maternity records were obtained, to collect information on child's gender, birth weight and length and other possible birth outcomes.

Conditions

Vitamin D Deficiency; Body Composition; Vascular Health; Cardiometabolic Risk

Outcome Measures

Primary Outcomes (10)

• Body composition

  Fat mass, derived from bioelectrical impedance, will be studied as percentage (%) of the total body weight.

  At 7-9 years of age

• Waist circumference

  Measurements of waist circumference (in cm) will be assessed.

  At 7-9 years of age

• Blood pressure

  Blood pressure in mm Hg will be assessed.

  At 7-9 years of age

• Blood lipids

  Triglycerides in nmol/L will be assessed from a venous blood sample

  At 7-9 years of age

• Blood glucose

  Glucose in mmol/L will be analyzed from a venous blood sample

  At 7-9 years of age

• Endothelial function

  Endothelial function will be assessed as reactive hyperemia (RH)-index

  At 7-9 years of age

• Pulse wave velocity

  Pulse wave velocity (neck to thigh) will be measured in meters per second

  At 7-9 years of age

• Ultrasound

  Ultra-high frequency ultrasound of dorsalis pedis (in mm) will be measured

  At 7-9 years of age

• Ultrasound

  Ultra-high frequency ultrasound of radialis (in mm) will be measured

  At 7-9 years of age

• Blood lipids

  HDL-cholesterol in nmol/L will be assessed from a venous blood sample

  At 7-9 years of age

Interventions

Maternal vitamin D status OTHER

Maternal vitamin D status (serum 25-hydroxyvitamin D) was collected during the GraviD study, while the woman was pregnant with the child now being followed-up in the GraviD-child study

Eligibility Criteria

• Age: 7 Years - 9 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

All healthy singleton children born within the GraviD study

You may qualify if:

• Born within the GraviD study
• Healthy
• Singleton

You may not qualify if:

• Chromosomal abnormality
• Hyper-/Hypothyroidism

Sponsors & Collaborators

• Göteborg University: lead
• Sahlgrenska University Hospital: collaborator
• Norwegian Institute of Public Health: collaborator

Study Sites (1)

Queen Silvia Children's Hospital

Gothenburg, 41650, Sweden

Location

Biospecimen

Retention: SAMPLES WITH DNA

Whole blood, serum, plasma

MeSH Terms

Conditions

Vitamin D Deficiency

Condition Hierarchy (Ancestors)

Avitaminosis; Deficiency Diseases; Malnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases

Study Officials

• Hanna Augustin, Ass Prof

  Göteborg University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 18, 2021
• First Posted: February 8, 2022
• Study Start: February 1, 2022
• Primary Completion: January 1, 2023
• Study Completion: February 14, 2023
• Last Updated: September 18, 2023

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will not share

Locations

SE (1)