NCT03516968 Monthly Boluses Versus Daily Doses for Correcting Blood Vitamin D Deficit in Obese Children and Adolescents
| NCT ID | NCT03516968 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | Hospices Civils de Lyon |
| Condition | Obesity, Childhood |
| Study Type | INTERVENTIONAL |
| Enrollment | 68 participants |
| Start Date | 2023-12-04 |
| Primary Completion | 2027-03 |
Eligibility & Interventions
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 3 trials are large pivotal studies comparing the treatment to current standard of care or placebo. Your participation directly contributes to the evidence needed for regulatory approval.
This trial targets 68 participants in total. It began in 2023-12-04 with a primary completion date of 2027-03.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
Childhood obesity is one of the most serious public health challenges of the 21st century, with an increasing prevalence over time in developed countries. Overweight and obese children and adolescents are likely to remain so into adulthood and to develop chronic diseases at a young age, such as diabetes and cardiovascular disease. Obese patients, whether adults or children, are likely to have low serum vitamin D levels due to sequestration and/or volumetric dilution of this fat-soluble vitamin in adipose tissue. Studies have established a link between vitamin D deficiency or insufficiency and chronic diseases such as hypertension, type 2 diabetes and other metabolic problems. Determining physiological 25(OH)D levels to ensure optimal phosphocalcic metabolism and bone mineralisation requires the use of functional markers: parathyroid hormone (PTH) levels, assessment of the intestinal calcium absorption fraction, assessment of bone mineral density and bone mineral content using absorptiometry. Vitamin D deficiency leads to malabsorption of calcium and phosphate in the digestive tract, with concentrations, especially of calcium, tending to fall in plasma, resulting in hypersecretion of PTH, which mobilises bone calcium to maintain subnormal blood calcium levels. Each unit increase in BMI is associated with lower serum vitamin D concentrations: given these low concentrations in this population associated with the risk of developing pathologies, it is important to ensure adequate vitamin D supplementation. The latest paediatric recommendations recommend, for children aged between 1 and 18 with vitamin D deficiency, a supplement of 2,000 IU/day for at least 6 weeks or a bolus of 50,000 IU once a week for at least 6 weeks. There are different dosage regimens for the replacement of vitamin D deficiency depending on the country: there is a lack of data on the appropriate dosage and administration regimens for vitamin D supplementation in cases of deficiency, particularly in obese children and adolescents. A prospective, randomised clinical trial will make it possible to define the vitamin D supplementation regimen best suited to increasing serum vitamin D levels in these children and adolescents suffering from obesity.
Eligibility Criteria
Inclusion Criteria: * Aged between 5 to 18 year-old * Being obese (BMI \>97th percentile, \> IOTF 30, for age and gender using the WHO references) * Patients (parents) having given their informed consent * Patient having insurance from the national health system Exclusion Criteria: Children will be excluded from the study if: * Symptomatic vitamin D deficiency (tetany, muscular hypotonia, hypocalcaemic seizure) * Vitamin D supplementation in the 3 months preceding the inclusion visit (V1) * Signs of rickets at the X-ray (osteopenia and cortical thinning of the long bones, stress fractures, and metaphyseal widening and fraying) * Chronic disease such as granulomatous conditions, Williams syndrome, or hypothyroidism predisposing to hypocalcaemia or in case of hypercalcaemia (calcium \> 2.65 mmol/L), liver/kidney disease, malabsorption diseases; * Hypercalciuria (urinary Calcium/Creatinine \> 0.7 mmol/mmol), calcium nephrolithiasis, hypervitaminosis D (25-(OH)D \> 250 nmol/L); nephrocalcinosis; * Ongoing treatment with anticonvulsants/barbiturates or steroids which increase the catabolism of 25(OH)D; * Ongoing treatment with thiazides diuretics which reduce urinary excretion of calcium; * Contraindications to the class of drugs under study, e.g. known hypersensitivity or allergy to class of drugs or the investigational product; * Pregnancy, breastfeeding; * Inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, dementia, etc. of the participant; * Simultaneous enrolment to another study which could influence the results of the current study; * Patient under legal protection or deprived of liberty.
Contact & Investigator
Carine Villanueva
PRINCIPAL INVESTIGATOR
Hospices Civils de Lyon
Frequently Asked Questions
Who can join the NCT03516968 clinical trial?
This trial is open to participants of all sexes, aged 5 Years or older, up to 18 Years, studying Obesity, Childhood. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT03516968 trial and what does that mean for participants?
Phase 3 trials are large-scale studies comparing the new treatment to existing standards of care or a placebo. They provide the evidence needed for regulatory approval. This trial targets 68 participants.
Is NCT03516968 currently recruiting?
Yes, NCT03516968 is actively recruiting participants. Contact the research team at carine.villanueva@chu-lyon.fr for enrollment information.
Where is the NCT03516968 trial being conducted?
This trial is being conducted at Bron, France, Bron, France, Clermont-Ferrand, France, Romagnat, France.
Who is sponsoring the NCT03516968 clinical trial?
NCT03516968 is sponsored by Hospices Civils de Lyon. The principal investigator is Carine Villanueva at Hospices Civils de Lyon. The trial plans to enroll 68 participants.
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