GraviD-child Follow-up of the Children´s Health, Growth & Development

Status Completed

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.

Clinical Trial 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 Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT05228925
Study type	Observational
Source	Göteborg University
Contact
Status	Completed
Phase
Start date	February 1, 2022
Completion date	February 14, 2023

View Details

See also
Status	Clinical Trial	Phase
Active, not recruiting	`NCT04244474` - Effect of Vitamin D Supplementation on Improvement of Pneumonic Children	Phase 1/Phase 2
Recruiting	`NCT05459298` - ViDES Trial (Vitamin D Extra Supplementation)	N/A
Suspended	`NCT03652987` - Endocrine and Menstrual Disturbances in Women With Polycystic Ovary Syndrome (PCOS)
Completed	`NCT04476511` - The Efficacy and the Safety of Vitamin D3 30,000 IU for Loading Dose Schedules	Phase 3
Completed	`NCT03920150` - Vitamin D 24'000 IU for Oral Intermittent Supplementation	Phase 3
Completed	`NCT03264625` - The Effects of Oral Vitamin D Supplementation on the Prevention of Peritoneal Dialysis-related Peritonitis	Phase 2
Completed	`NCT04183257` - Effect of Escalating Oral Vitamin D Replacement on HOMA-IR in Vitamin D Deficient Type 2 Diabetics	Phase 4
Recruiting	`NCT05084248` - Vitamin D Deficiency in Adults Following a Major Burn Injury	Phase 4
Completed	`NCT05506696` - Vitamin D Supplementation Study	N/A
Completed	`NCT00092066` - A Study to Evaluate the Safety, Tolerability, and Efficacy of an Investigational Drug and Dietary Supplement in Men and Postmenopausal Women With Osteoporosis (0217A-227)	Phase 3
Completed	`NCT03234218` - Vitamin D Levels in Liver Transplantation Recipients Prospective Observational Study
Completed	`NCT02906319` - Vitamin D and HbA1c Levels in Diabetic Patients With CKD	N/A
Completed	`NCT02714361` - A Study to Investigate the Effect of Vitamin D3 Supplementation on Iron Status in Iron Deficient Women	N/A
Completed	`NCT03203382` - Corneal Nerve Structure in Sjogren's
Completed	`NCT02118129` - Vitamin D Among Young Adults: an Intervention Study Using a Mobile 'App'.	N/A
Not yet recruiting	`NCT01419821` - Vitamin D and Its Affect on Growth Rates and Bone Mineral Density Until Age 5	N/A
Completed	`NCT02275650` - The Role of Narrowband Ultraviolet B Exposure in the Maintenance of Vitamin D Levels During Winter	N/A
Completed	`NCT02187146` - The Effects of Serum Vitamin D and IVF Outcome	N/A
Completed	`NCT01741181` - Vitamin D Supplementation in Patients With Diabetes Mellitus Type 2	Phase 4
Completed	`NCT01651000` - Safety and Efficacy of CTAP101 to Treat Secondary Hyperparathyroidism in Stage 3 or 4 CKD and Vitamin D Insufficiency	Phase 3

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

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

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms