Comparing Monthly Versus Daily Vitamin D Supplements to Treat Deficiency in Obese Children and Teens Aged 5 to 18

What this Trial Is About

Childhood obesity is a growing public health concern with increasing rates in developed countries. Obese children and adolescents are more likely to remain obese into adulthood and develop chronic diseases early, such as diabetes and cardiovascular conditions. Low vitamin D levels are common in obese patients due to fat tissue effects, which may contribute to metabolic disorders. This study evaluates two different vitamin D supplementation regimens to determine the best approach for correcting vitamin D deficiency in obese children and adolescents aged 5 to 18 years. The trial compares two oral vitamin D treatments a monthly bolus regimen consisting of an initial 50,000 IU dose followed by a second 50,000 IU dose after six weeks, and a daily dose regimen of 1,200 IU per day for three months. This randomized controlled study is open-label and sponsored by Hospices Civils de Lyon. The aim is to find which regimen better increases serum vitamin D levels while monitoring related metabolic and bone health markers. Participants will undergo assessments including blood tests for vitamin D, calcium, phosphate, and parathyroid hormone levels, urine tests, and bone mineral density scans at the start and after three months. Treatment adherence and the influence of factors like skin type, physical activity, sun exposure, and diet will also be evaluated. The primary outcome is the proportion of patients reaching a therapeutic vitamin D level between 50 and 120 nmolL at three months. The study ensures ongoing monitoring and thorough evaluation during the treatment period.

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