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

Vitamin D Deficiency Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05228925
• Other study ID #: 2018-00441
• Status: Completed
• Start date: February 1, 2022
• Est. completion date: February 14, 2023

Study information

• Verified date: September 2023
• Source: Göteborg University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 172
• Est. completion date: February 14, 2023
• Est. primary completion date: January 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 7 Years to 9 Years

Eligibility

Inclusion Criteria:

• Born within the GraviD study

• Healthy

• Singleton

Exclusion Criteria:

• Chromosomal abnormality

• Hyper-/Hypothyroidism

Related Conditions & MeSH terms

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

Intervention

Other:
• Maternal 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

Locations

Country	Name	City	State
Sweden	Queen Silvia Children's Hospital	Gothenburg

Sponsors (3)

Lead Sponsor	Collaborator
Göteborg University	Norwegian Institute of Public Health, Sahlgrenska University Hospital, Sweden

Country where clinical trial is conducted

Sweden, 

Outcome

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