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OBEVIDOS “Treatment of vitamin D deficit in obese children and adolescents: an open label randomized controlled study comparing the efficacy of two oral supplementation regimens: monthly boluses versus daily doses for correcting blood vitamin D level.”
EU CTIS ID: 2023-507089-18-00
What this study is testing
The primary objective is to compare the efficacy of two vitamin D supplementation regimens (monthly bolus substitution versus daily substitution), to increase serum vitamin D level in obese children and adolescents.
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- age ≥ 5 years and < 18 years
- Obesity defined by BMI >97th percentile (>IOTF 30) for age and gender using WHO references
- Assent of the patients and written consent of both parents/legal guardians
- Patient affiliated to the national health system or benefiting from it
You likely can't join if
- Symptomatic vitamin D deficiency (tetany, muscular hypotonia, hypocalcaemic seizure)
- Pregnancy, breastfeeding
- Inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, dementia, etc. of the participant
- Vitamin D supplementation in the 3 months preceding the inclusion visit (V1)
- Simultaneous enrolment to another study which could influence the results of the current study
- Ongoing treatment with thiazides diuretics which reduce urinary excretion of calcium
See the full eligibility criteria
- age ≥ 5 years and < 18 years
- Obesity defined by BMI >97th percentile (>IOTF 30) for age and gender using WHO references
- Assent of the patients and written consent of both parents/legal guardians
- Patient affiliated to the national health system or benefiting from it
- Symptomatic vitamin D deficiency (tetany, muscular hypotonia, hypocalcaemic seizure)
- Pregnancy, breastfeeding
- Inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, dementia, etc. of the participant
- Vitamin D supplementation in the 3 months preceding the inclusion visit (V1)
- Simultaneous enrolment to another study which could influence the results of the current study
- Ongoing treatment with thiazides diuretics which reduce urinary excretion of calcium
- Patient under legal protection or deprived of liberty
- 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 affecting vitamin D or phosphocalcium metabolism
- 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
- Contraindications to the class of drugs under study, e.g. known hypersensitivity or allergy to class of drugs or the investigational product
The study team makes the final eligibility decision.
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, 0-17 years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.