Actively Recruiting
Effect of Vitamin D Supplementation on Insulin Resistance in School-Aged Children and Adolescents with Obesity
Led by Coordinación de Investigación en Salud, Mexico · Updated on 2025-03-24
40
Participants Needed
1
Research Sites
4 weeks
Total Duration
On this page
Sponsors
C
Coordinación de Investigación en Salud, Mexico
Lead Sponsor
H
Hospital Infantil de Mexico Federico Gomez
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are studying the effects of vitamin D supplementation on insulin resistance and the leptin/adiponectin ratio in school-aged children and adolescents with obesity. The trial focuses on participants aged 10 to 18 years with obesity defined by a BMI above the 95th percentile. This controlled, randomized, double-blind clinical trial aims to compare two daily doses of vitamin D to understand their impact on metabolic factors related to obesity and insulin resistance. Participants are randomly assigned to receive either 4,000 IU or 1,000 IU of vitamin D daily for six months. All children and their parents receive dietary and physical activity guidance based on World Health Organization recommendations. Monthly visits ensure capsule intake adherence and monitor for any adverse effects. The study is conducted at two pediatric hospitals and maintains blinding for medical staff, patients, families, and data collectors through identical capsules. Throughout the study, participants undergo measurements of weight, height, body fat, Tanner stage, and blood tests including leptin, adiponectin, insulin, lipid profiles, and glucose at the start and end of the six months. Researchers will analyze changes in vitamin D levels, insulin resistance (HOMA-IR), lipid profiles, and body mass index. Statistical methods will evaluate the effects of supplementation while monitoring safety and adherence, with the trial concluding after the final assessments at six months.
CONDITIONS
Brief Title
Efficacy and Safety of Vitamin D Supplementation in Pediatric Patients with Obesity
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male and female participants
- Age between 10 and 18 years
- Obesity defined by BMI above the 95th percentile for age and sex according to WHO tables
- Willingness to participate in the study
- Residency in Mexico City
You will not qualify if you...
- Presence of comorbidities unrelated to obesity such as chronic kidney disease, heart failure, or liver cirrhosis
- Diagnosis of genetic syndromes including Prader-Willi syndrome, Albright's hereditary osteodystrophy, Borjesson-Forssman-Lehmann syndrome
- Current use of vitamin supplements
- Current pharmacological treatment for obesity
- Existing insulin resistance requiring pharmacological treatment with metformin, even if not previously medicated
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 6 months
Participants receive daily vitamin D supplementation of either 4000 IU or 1000 IU for six months while following dietary and physical activity plans.
Monthly visits for up to 6 months
Duration - 1 day
Participants undergo a final assessment including anthropometric and blood sample evaluations to assess changes after treatment.
1 visit (in-person)
Trial Site Locations
Total: 1 location
1
Hospital Infantil de Mexico Federico Gomez
México, Mexico, 06720
Actively Recruiting
Research Team
J
JESSIE NALLELY Zurita-Cruz
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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