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Compares treatment options for Obesity, Childhood
Official title Monthly Boluses Versus Daily Doses for Correcting Blood Vitamin D Deficit in Obese Children and Adolescents
ClinicalTrials.gov ID: NCT03516968
What this study is testing
What is Monthly bolus of cholecalciferol per os?
Monthly bolus of cholecalciferol per os is an investigational medicine, given as an once-weekly, being studied as a potential treatment for obesity, childhood.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 3: a large, late-stage study
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 5 to 18
You may be able to join if
- 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
You likely can't join if
- 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...
- Hypercalciuria (urinary Calcium/Creatinine \> 0.7 mmol/mmol), calcium nephrolithiasis, hypervitaminosis D (25-(OH)D \> 250 nmol/L); nephrocalcinosis;
See the full eligibility 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
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Bron, France
- Clermont-Ferrand, France
- Romagnat, France
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 5 years to 18 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Bron, France; Clermont-Ferrand, France; Romagnat, France. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.