Vitamin D supplementation for obese children

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• Hospital Infantil de Mexico Federico Gomez
  México, Mexico Recruiting

Study contacts

• Study coordinator: JESSIE NALLELY Zurita-Cruz
• Email: zuritajn@gmail.com
• Phone: 5554194513

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.