Vitamin D supplementation for obese children
Efecto De La Suplementación De Vitamina D En La Resistencia a La Insulina En Escolares Y Adolescentes Con Obesidad
This study is testing whether different doses of vitamin D can help obese kids and teens improve their insulin levels and body fat over six months.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 40 (estimated) |
| Ages | 10 Years to 18 Years |
| Sex | All |
| Sponsor | Coordinación de Investigación en Salud, Mexico Government |
| Locations | 1 site (México) |
| Trial ID | NCT06847373 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the effects of two different doses of vitamin D supplementation (4,000 IU vs. 1,000 IU) over six months on insulin resistance and the leptin/adiponectin ratio in school-aged children and adolescents with obesity. The study will involve 40 participants aged 10 to 18 years, who will be randomly assigned to one of the two treatment groups. Participants will undergo various measurements, including BMI and body fat, and will receive dietary and physical activity recommendations. The trial is designed as a randomized, double-blind, controlled study conducted at two hospitals in Mexico City.
Who should consider this trial
Good fit: Ideal candidates for this study are school-aged children and adolescents aged 10 to 18 years with obesity defined as a BMI greater than the 95th percentile.
Not a fit: Patients with comorbidities unrelated to obesity or those currently receiving vitamin supplements or pharmacological treatments for obesity may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide insights into effective vitamin D supplementation strategies to improve insulin resistance in obese children.
How similar studies have performed: While there is ongoing research into vitamin D and obesity, this specific approach of comparing two different supplementation doses in a pediatric population is relatively novel.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
México
- Hospital Infantil de Mexico Federico Gomez — México, Mexico (Recruiting)
Study contacts
- Study coordinator: JESSIE NALLELY Zurita-Cruz
- Email: zuritajn@gmail.com
- Phone: 5554194513
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.