Efficacy and Safety of Vitamin D Supplementation in Pediatric Patients with Obesity

Launched by COORDINACIÓN DE INVESTIGACIÓN EN SALUD, MEXICO · Feb 21, 2025

Keywords

ClinConnect Summary

This clinical trial is studying the effects of vitamin D supplementation in children and teenagers with obesity, specifically looking at how different doses of vitamin D might affect their insulin resistance, which is how well their bodies can use insulin to manage sugar levels. The researchers want to see if giving children either 4,000 IU (international units) or 1,000 IU of vitamin D daily for six months can make a difference in their health.

To participate, children must be between 10 and 18 years old and have obesity, measured by a high Body Mass Index (BMI). They should be living in Mexico City and be willing to take part in the study. However, children with certain medical conditions or those currently taking vitamin supplements or medications for obesity cannot join. Throughout the study, participants will receive guidance on diet and exercise, and their health will be monitored regularly to track any changes. This research could help improve our understanding of how vitamin D affects children with obesity and insulin resistance.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Male and female participants.
• • Participants aged between 10 and 18 years.
• • Obesity as defined by a Body Mass Index (BMI) in the \>95th percentile according to the World Health Organization's age and sex-specific tables.
• • Willingness to participate in the study.
• • Residency in Mexico City.
• Exclusion Criteria:
• • Patients with comorbidities not attributable to obesity, such as chronic kidney disease, heart failure, liver cirrhosis, etc.
• • Patients with Prader-Willi syndrome, Albright's hereditary osteodystrophy, Borjesson-Forssman-Lehmann syndrome.
• • Patients currently taking vitamin supplements.
• • Patients undergoing pharmacological treatment for obesity.
• • Patients who already present insulin resistance and, although they have not previously received medication, are currently indicated for pharmacological treatment with metformin.