Comparing monthly and daily vitamin D doses for obese children and adolescents

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: OBEVIDOS

This study tests whether giving obese kids and teens vitamin D once a month or every day works better to fix their vitamin D deficiency.

Quick facts

• Phase: Phase 3
• Study type: Interventional
• Enrollment: 68 (estimated)
• Ages: 5 Years to 18 Years
• Sex: All
• Sponsor: Hospices Civils de Lyon (Academic / other)
• Locations: 4 sites (Bron and 3 other locations)
• Trial ID: NCT03516968 on ClinicalTrials.gov

What this trial studies

This clinical trial investigates the effectiveness of monthly boluses versus daily doses of cholecalciferol (vitamin D) in correcting vitamin D deficiency in obese children and adolescents aged 5 to 18. Given the rising prevalence of obesity and its associated health risks, including cardiovascular diseases and type 2 diabetes, this study aims to determine the best supplementation strategy for improving vitamin D levels in this vulnerable population. Participants will be randomly assigned to receive either monthly or daily doses of vitamin D, with their health monitored throughout the trial.

Who should consider this trial

Good fit: Ideal candidates for this study are obese children and adolescents aged 5 to 18 years with a BMI above the 97th percentile for their age and gender.

Not a fit: Patients who have received vitamin D supplementation in the past three months or have symptomatic vitamin D deficiency or chronic diseases may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide an effective vitamin D supplementation strategy that improves health outcomes for obese children and adolescents.

How similar studies have performed: Other studies have shown promising results with vitamin D supplementation in obese populations, suggesting that this approach may be effective.

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.

Where this trial is running

Bron and 3 other locations

• Centre d'Investigation Clinique de LYON - CIC 1407- Groupement Hospitalier Est / Hospices Civils de Lyon — Bron, France (Recruiting)
• Service d'endocrinologie et métabolisme pédiatrique, Hôpital Femme Mère Enfant — Bron, France (Recruiting)
• Service d'Endocrinologie Pédiatrique CHU de Clermont-Ferrand — Clermont-Ferrand, France (Not_yet_recruiting)
• Centre Médical Infantile de Romagnat — Romagnat, France (Not_yet_recruiting)

Study contacts

• Principal investigator: Carine Villanueva — Hospices Civils de Lyon
• Study coordinator: Carine Villanueva, MD

Conditions Obesity, Childhood; Obesity; Vitamin D deficiency,; supplementation,; Child; Adolescent