Monthly bolus of cholecalciferol per os
DrugBolus therapy: first 50 000 IU and a second 50 IU after 6 weeks
NCT Number: NCT03516968
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.
Interested in participating?
Request Info5 year–18 year
All sexes
Interventional
Phase 3
Centre d'Investigation Clinique de LYON - CIC 1407- Groupement Hospitalier Est / Hospices Civils de Lyon, Bron, France
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Children will be excluded from the study if:
Bolus therapy: first 50 000 IU and a second 50 IU after 6 weeks
Daily substitution, 1200 IU per day (4 drops), for 3 months
Time frame: Month 3
Vitamin D (25OH)D) serum level
Time frame: Month 3
blood safety dosages
Time frame: Month 3
blood safety dosages
Time frame: Month 3
blood safety dosages
Time frame: Month 3
urinary safety dosages
Time frame: Month 3
urinary safety dosages
Time frame: Month 3
amount of treatment taken (Daily arm: patient diary and weighting of returned treatment at M3. Bolus arm: description of taken ampoules after hospital dosing (number taken, empty or not))
Time frame: Month 3
assessed a questionnaire
Time frame: Month 3
assessed by a questionnaire
Time frame: Month 3
assessed by a questionnaire
Time frame: Month 3
assessed by questionnaires
Time frame: Day 1
Bone mineral density
Time frame: Month 3
PTH serum level
Time frame: Day 1
Bone mineral density (DXA)
Contact information is provided by the study sponsor or research team.
Hospices Civils de Lyon
Other
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
Acronym: OBEVIDOS
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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