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.

Study Overview

• Status: Completed
• Conditions: Vitamin D Deficiency; Body Composition; Cardiometabolic Risk; Vascular Health
• Intervention / Treatment: Other: Maternal vitamin D status

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 Type: Observational
• Enrollment (Actual): 172

Contacts and Locations

Study Locations

• Sweden
  • Gothenburg, Sweden, 41650
    • Queen Silvia Children's Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 7 years to 9 years (Child)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

All healthy singleton children born within the GraviD study

Description

Inclusion Criteria:

• Born within the GraviD study
• Healthy
• Singleton

Exclusion Criteria:

• Chromosomal abnormality
• Hyper-/Hypothyroidism

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Göteborg University
• Collaborators: Norwegian Institute of Public Health; Sahlgrenska University Hospital, Sweden
• Investigators: Principal Investigator: Hanna Augustin, Ass Prof, Göteborg University

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2022
• Primary Completion (Actual): January 1, 2023
• Study Completion (Actual): February 14, 2023

Study Registration Dates

• First Submitted: November 18, 2021
• First Submitted That Met QC Criteria: January 27, 2022
• First Posted (Actual): February 8, 2022

Study Record Updates

• Last Update Posted (Actual): September 18, 2023
• Last Update Submitted That Met QC Criteria: September 15, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nutrition Disorders; Avitaminosis; Deficiency Diseases; Malnutrition; Vitamin D Deficiency; Physiological Effects of Drugs; Micronutrients; Vitamins; Bone Density Conservation Agents; Vitamin D
• Other Study ID Numbers: 2018-00441

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No