AzTrials
AzTrials

Vitamin D DeficiencyNCT05228925

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

An observational study of Vitamin D Deficiency and Body Composition, run by Göteborg University at 1 site in Sweden.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

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. Read more about this study

Who is it for?
Ages 7 to 9 years
What is being tested?
Maternal vitamin D status
How many people
172 participants
Where
1 siteSweden
Study dates
1 Feb 2022to 14 Feb 2023
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 7 to 9 years
  • All sexes
  • No healthy volunteers
  • Child

Study population: All healthy singleton children born within the GraviD study

Who may be able to join

  • Born within the GraviD study
  • Healthy
  • Singleton

Who cannot join

  • Chromosomal abnormality
  • Hyper-/Hypothyroidism

Trial locations and contacts

1 site in 1 country.

Sweden1 site

  • Queen Silvia Children's Hospital

    Gothenburg, 41650

Other trials in Sweden

About this 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.

Read the 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.

Being tested
Maternal vitamin D status
Medical subject headings
Vitamin D Deficiency

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Maternal vitamin D statusOther

    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

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Body composition

    Fat mass, derived from bioelectrical impedance, will be studied as percentage (%) of the total body weight.

    Measured: At 7-9 years of age

  2. Waist circumference

    Measurements of waist circumference (in cm) will be assessed.

    Measured: At 7-9 years of age

  3. Blood pressure

    Blood pressure in mm Hg will be assessed.

    Measured: At 7-9 years of age

  4. Blood lipids

    Triglycerides in nmol/L will be assessed from a venous blood sample

    Measured: At 7-9 years of age

  5. Blood glucose

    Glucose in mmol/L will be analyzed from a venous blood sample

    Measured: At 7-9 years of age

  6. Endothelial function

    Endothelial function will be assessed as reactive hyperemia (RH)-index

    Measured: At 7-9 years of age

  7. Pulse wave velocity

    Pulse wave velocity (neck to thigh) will be measured in meters per second

    Measured: At 7-9 years of age

  8. Ultrasound

    Ultra-high frequency ultrasound of dorsalis pedis (in mm) will be measured

    Measured: At 7-9 years of age

  9. Ultrasound

    Ultra-high frequency ultrasound of radialis (in mm) will be measured

    Measured: At 7-9 years of age

  10. Blood lipids

    HDL-cholesterol in nmol/L will be assessed from a venous blood sample

    Measured: At 7-9 years of age

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Feb 2022
  2. Study start1 Feb 2022
  3. Primary completion1 Jan 2023
  4. Study completion14 Feb 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
172 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05228925
Sponsor's protocol ID
2018-00441
Other IDs
2018
Status last verified
Sep 2023
First submitted
18 Nov 2021
Last updated
18 Sep 2023
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Barebring L, Amberntsson A, Forsby M, Karlsson T, Dangardt F, Winkvist A, Augustin H. Ultra-processed food intake in relation to anthropometrics and biomarkers of cardiometabolic health among Swedish children: a cross-sectional study within the GraviD-Child cohort. BMC Nutr. 2026 Apr 28;12(1):82. doi: 10.1186/s40795-026-01337-w.

    PubMed 42050732

  • Forsby M, Barebring L, Amberntsson A, Dangardt F, Winkvist A, Augustin H. Vitamin D status and intake in early school-aged children is tracking from pregnancy-the Swedish GraviD-Child study. BMC Pediatr. 2026 Apr 27;26(1):384. doi: 10.1186/s12887-026-06914-3.

    PubMed 42045872

Questions about this trial

What is this clinical trial studying?

An observational study of Vitamin D Deficiency and Body Composition, run by Göteborg University at 1 site in Sweden.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 18 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Body composition (time frame: At 7-9 years of age). The study lists 10 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05228925, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Sep 2023.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in