NCT06847373Recruiting
Efficacy and Safety of Vitamin D Supplementation in Pediatric Patients with Obesity
Efecto De La Suplementación De Vitamina D En La Resistencia a La Insulina En Escolares Y Adolescentes Con Obesidad
Source: ClinicalTrials.gov · Last updated 24 Mar 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
Introduction: Vitamin D deficiency is commonly observed in patients with obesity, primarily due to sequestration by adipose tissue. Recent research highlights the importance of this deficiency, showing a correlation between low vitamin D levels and mechanisms contributing to insulin resistance. Objectives: This study aims to compare the effects of supplementing with 4,000 IU of vitamin D versus 1,000 IU over six months on insulin resistance and the leptin/adiponectin ratio in school-aged children and adolescents with obesity. Materials and Methods: A controlled clinical trial will be conducted involving 40 children with obesity aged 10 to 18 years (BMI \>95th percentile). Participating children and their parents will undergo measurements such as weight, height, BMI, body fat, and Tanner stage. All participants will receive dietary and physical activity recommendations based on WHO guidelines. After initial assessments, participants will be randomly assigned to receive either 4,000 IU or 1,000 IU of vitamin D. They will be monitored monthly for capsule intake and adverse effects, with follow-up measurements of anthropometry, leptin, adiponectin, insulin \& lipid profile. Statistical Analysis: Baseline characteristics will be compared using t-Student or U-Mann Whitney tests, depending on variable distribution. The intervention's impact will be assessed by calculating deltas for body fat and biochemical measurements, with significance tested using paired t-tests or Wilcoxon tests. Covariance analysis (ANCOVA) will be used to adjust for confounding variables.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 40 (estimated)
- First submitted
- 21 Feb 2025
- Start date
- 1 Mar 2025
- Primary completion date
- 30 Sept 2025
- Lead sponsor
- Coordinación de Investigación en Salud, Mexico
- Diseases
- Obesity
- NCT number
- NCT06847373
What you commit to
- Study type: Interventional
- Planned participants: 40
- From 1 Mar 2025 to the primary completion date, 30 Sept 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Patients currently taking vitamin supplements.
- Patients who already present insulin resistance and, although they have not previously received medication, are currently indicated for pharmacological treatment with metformin.
Other illness
- 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.
Other
- Patients undergoing pharmacological treatment for obesity.
Who the study is looking for
- 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.
Age in the registry: 10 years to 18 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Hospital Infantil de Mexico Federico Gomez Coordinator of this site? Confirm its status | México | Mexico | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.