Clinical trial NCT05228925: GraviD-child Follow-up of the Children´s Health, Growth and Development Within the GraviD-study
Official title: GraviD-child Follow-up of the Children´s Health, Growth and Development Within the GraviD-study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Vitamin D Deficiency
Body Composition
Vascular Health
Cardiometabolic Risk
Lead sponsor: Göteborg University
Sponsor class: OTHER
Collaborators: name: Sahlgrenska University Hospital
name: Norwegian Institute of Public Health
First posted: 2022-02-08
Enrollment: 172
Sex: ALL
Minimum age (years): 7
Maximum age (years): 9
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All healthy singleton children born within the GraviD study

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.

Detailed description: 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:

1. Measurement of body weight and height, and waist circumference.
2. A questionnaire regarding health, physical activity, sleeping habits and diet.
3. Endothelial function, a measure of how well the blood vessels dilute.
4. Ultra sound of the thickness of the vessels on the neck, wrist and foot
5. Pulse wave velocity, to measure the elasticity of the vessels on the neck and groin.
6. Body composition using bioelectrical impedance.
7. Blood pressure
8. 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.

Eligibility criteria: Inclusion Criteria:

* Born within the GraviD study
* Healthy
* Singleton

Exclusion Criteria:

* Chromosomal abnormality
* Hyper-/Hypothyroidism

Primary outcomes:
measure: Body composition
timeFrame: At 7-9 years of age
measure: Waist circumference
timeFrame: At 7-9 years of age
measure: Blood pressure
timeFrame: At 7-9 years of age
measure: Blood lipids
timeFrame: At 7-9 years of age
measure: Blood glucose
timeFrame: At 7-9 years of age
measure: Endothelial function
timeFrame: At 7-9 years of age
measure: Pulse wave velocity
timeFrame: At 7-9 years of age
measure: Ultrasound
timeFrame: At 7-9 years of age
measure: Ultrasound
timeFrame: At 7-9 years of age
measure: Blood lipids
timeFrame: At 7-9 years of age
Secondary outcomes:
Other outcomes:
Locations:
city: Gothenburg
country: Sweden
facility: Queen Silvia Children's Hospital
Study officials:
affiliation: Göteborg University
name: Hanna Augustin, Ass Prof
role: PRINCIPAL_INVESTIGATOR
References: