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

Completed

• Conditions: Vitamin D Deficiency; Body Composition; Vascular Health; Cardiometabolic Risk

• Registration Number: NCT05228925
• Lead Sponsor: Göteborg University

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.

Study Timeline

• Study First Submitted: 2021-11-18
• Study First Submitted QC: 2022-01-27
• Study Start: 2022-02-01
• Study First Posted: 2022-02-08
• Primary Completion: 2023-01-01
• Study Completion: 2023-02-14
• Status Verified: 2023-09
• Last Update Submitted: 2023-09-15
• Last Update Posted: 2023-09-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 172

Inclusion Criteria

• Born within the GraviD study
• Healthy
• Singleton

Exclusion Criteria

• Chromosomal abnormality
• Hyper-/Hypothyroidism

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Blood glucose	At 7-9 years of age	Glucose in mmol/L will be analyzed from a venous blood sample
Ultrasound	At 7-9 years of age	Ultra-high frequency ultrasound of radialis (in mm) will be measured
Body composition	At 7-9 years of age	Fat mass, derived from bioelectrical impedance, will be studied as percentage (%) of the total body weight.
Blood pressure	At 7-9 years of age	Blood pressure in mm Hg will be assessed.
Pulse wave velocity	At 7-9 years of age	Pulse wave velocity (neck to thigh) will be measured in meters per second
Waist circumference	At 7-9 years of age	Measurements of waist circumference (in cm) will be assessed.
Blood lipids	At 7-9 years of age	HDL-cholesterol in nmol/L will be assessed from a venous blood sample
Endothelial function	At 7-9 years of age	Endothelial function will be assessed as reactive hyperemia (RH)-index

Trial Locations

Locations (1)

Queen Silvia Children's Hospital; 🇸🇪 Gothenburg, Sweden