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Completed

NCT Number: NCT05228925

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

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.

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Key information

Conditions

Vitamin D Deficiency Avitaminosis Body Composition Cardiometabolic Risk Deficiency Diseases Malnutrition Nutrition Disorders Nutritional and Metabolic Diseases Vascular Health

Age range

7 year–9 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Queen Silvia Children's Hospital

Gothenburg, 41650, Sweden

About this study

In the GraviD-child study, all healthy singleton children born within the GraviD study will be invited to participate in a single clinical follow up. The follow-up will be conducted when all children are between 7-8 years of age. The study centre is located at the Queen Silvia Children´s hospital in Gothenburg, Sweden. The follow up consist of several parts:

  • Measurement of body weight and height, and waist circumference.
  • A questionnaire regarding health, physical activity, sleeping habits and diet.
  • Endothelial function, a measure of how well the blood vessels dilute.
  • Ultra sound of the thickness of the vessels on the neck, wrist and foot
  • Pulse wave velocity, to measure the elasticity of the vessels on the neck and groin.
  • Body composition using bioelectrical impedance.
  • Blood pressure
  • A venous blood sample of maximum 18 ml will be drawn to analyze markers of cardiovascular health. Blood lipids (total cholesterol, triglycerides, HDL cholesterol, LDL cholesterol), lipoprotein A, apolipoproteins (Apo A1 and Apo B), liver enzymes, glucose, insulin, HbA1c, c-reactive protein, leptin, adiponectin, nutritional biomarkers (such as 25-hydroxyvitamin D) will be analyzed.

The study hypothesis is that a low maternal vitamin D status increase the risk of an unfavorable child cardiometabolic risk profile, vascular health and body composition.

Recruitment start in January 2022 and will run for about a year.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Born within the GraviD study
  • Healthy
  • Singleton

Exclusion criteria

  • Chromosomal abnormality
  • Hyper-/Hypothyroidism

Treatment and study plan

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

Primary outcomes

  1. Body composition

    Time frame: At 7-9 years of age

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

  2. Waist circumference

    Time frame: At 7-9 years of age

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

  3. Blood pressure

    Time frame: At 7-9 years of age

    Blood pressure in mm Hg will be assessed.

  4. Blood lipids

    Time frame: At 7-9 years of age

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

  5. Blood glucose

    Time frame: At 7-9 years of age

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

  6. Endothelial function

    Time frame: At 7-9 years of age

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

  7. Pulse wave velocity

    Time frame: At 7-9 years of age

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

  8. Ultrasound

    Time frame: At 7-9 years of age

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

  9. Ultrasound

    Time frame: At 7-9 years of age

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

  10. Blood lipids

    Time frame: At 7-9 years of age

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

Sponsors and collaborators

Lead sponsor

Göteborg University

Other

Collaborators

  • Norwegian Institute of Public Health
  • Sahlgrenska University Hospital

Registry information

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Feb 8, 2022
Registry last updated
Sep 18, 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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