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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05228925
Enrollment
172
Registered
2022-02-08
Start date
2022-02-01
Completion date
2023-02-14
Last updated
2023-09-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

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.

Interventions

OTHERMaternal vitamin D status

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

Sponsors

Sahlgrenska University Hospital
CollaboratorOTHER
Norwegian Institute of Public Health
CollaboratorOTHER_GOV
Göteborg University
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
7 Years to 9 Years
Healthy volunteers
No

Inclusion criteria

* Born within the GraviD study * Healthy * Singleton

Exclusion criteria

* Chromosomal abnormality * Hyper-/Hypothyroidism

Design outcomes

Primary

MeasureTime frameDescription
Waist circumferenceAt 7-9 years of ageMeasurements of waist circumference (in cm) will be assessed.
Blood pressureAt 7-9 years of ageBlood pressure in mm Hg will be assessed.
Body compositionAt 7-9 years of ageFat mass, derived from bioelectrical impedance, will be studied as percentage (%) of the total body weight.
Blood lipidsAt 7-9 years of ageTriglycerides in nmol/L will be assessed from a venous blood sample
Blood glucoseAt 7-9 years of ageGlucose in mmol/L will be analyzed from a venous blood sample
Endothelial functionAt 7-9 years of ageEndothelial function will be assessed as reactive hyperemia (RH)-index
Pulse wave velocityAt 7-9 years of agePulse wave velocity (neck to thigh) will be measured in meters per second
UltrasoundAt 7-9 years of ageUltra-high frequency ultrasound of dorsalis pedis (in mm) will be measured

Countries

Sweden

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Apr 30, 2026