Monthly Boluses Versus Daily Doses for Correcting Blood Vitamin D Deficit in Obese Children and Adolescents

Condition(s) studied

Investigational drug(s) / intervention(s)

Monthly bolus of cholecalciferol per os: Bolus therapy: first 50 000 IU and a second 50 IU after 6 weeks

Daily dose of cholecalciferol per os: Daily substitution, 1200 IU per day (4 drops), for 3 months

Study 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

Primary outcome measure(s)

• Proportion of patients reaching the therapeutic target defined as vitamin D (25(OH)D) serum level ≥ 50 nmol/L and < 120 nmol/L — Month 3
  Vitamin D (25OH)D) serum level

Trial sites (4)

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