Efficacy and Safety of Vitamin D Supplementation in Pediatric Patients with Obesity
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age10-18
SponsorCoordinación de Investigación en Salud, Mexico
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial design
Design model
Parallel
Treatments tested in this trial
Cholecalciferol
Dietary supplementcholecalciferol 4000 IU daily orally
Treatment groups
40 Participants
are divided into 2 treatment groupsGroup A: Cholecalciferol 4000UI (Vitamin D)Experimental treatment 1 intervention
Group B: Cholecalciferol 1000U (Vitamin D)Sham comparator 1 intervention
Trial outcomes
Primary outcomes
1
Change from Baseline in 25 hydroxi vitamin D at 6 Months.
A peripheral blood sample will be collected. Patients are required to fast for 12 hours prior to presenting for blood sample collection, scheduled between 7:00 and 8:00 AM. Blood will be drawn via venipuncture and subsequently centrifuged at 3000 revolutions per minute for five minutes to separate the serum. The serum will be aliquoted and stored at -20 degrees Celsius until further analysis. The levels of 25-hydroxy Vitamin D will be quantified using an ELISA method, employing the 6913 25(OH) Vitamin D ELISA Kit (96 Tests - Abcam) in conjunction with the Varioskan™ LUX multimode microplate reader. At the end of the six-month study, a second blood sample will be collected to assess vitamin D levels at that time. Vitamin D Concentration Standards: Normal: Greater than 30 ng/mL Insufficiency: 20-30 ng/mL Deficiency: Less than 20 ng/mL
Time frame
From enrollment to the end of treatment at 6 months2
Change from Baseline in leptin at 6 Months.
A sample of peripheral blood will be collected to measure serum levels of leptin. Patients are required to fast for 12 hours and should arrive for the sample collection between 7:00 and 8:00 AM. The blood will be drawn through venipuncture. After collection, the sample will be centrifuged at 3000 revolutions per minute for five minutes. The serum will then be aliquoted for subsequent analyses. These serum samples will be stored at -20 degrees Celsius until they are analyzed. Leptin will be measured using the ELISA technique with the commercial kit from Merck Millipore, Milliplex Map Human Adipokine Magnetic Bead Panel Endocrine Multiplex Assay. At the end of the six-month study, a second blood sample will be collected to assess leptin levels at that time.
Time frame
From enrollment to the end of treatment at 6 months3
Change from Baseline in adiponectin at 6 Months.
A sample of peripheral blood will be collected to measure serum levels of adiponectin. Patients are required to fast for 12 hours and should arrive for the sample collection between 7:00 and 8:00 AM. The blood will be drawn through venipuncture. After collection, the sample will be centrifuged at 3000 revolutions per minute for five minutes. The serum will then be aliquoted for subsequent analyses. These serum samples will be stored at -20 degrees Celsius until they are analyzed. Adiponectin will be measured using the ELISA technique with the commercial kit from Merck Millipore, Milliplex Map Human Adipokine Magnetic Bead Panel Endocrine Multiplex Assay. At the end of the six-month study, a second blood sample will be collected to assess adiponectin levels at that time.
Time frame
From enrollment to the end of treatment at 6 months4
Change from Baseline in insulin at 6 Months.
Insulin is an anabolic hormone secreted by the pancreas that plays a role in regulating blood glucose level. A sample of peripheral blood will be collected to measure serum levels of insulin . Patients are required to fast for 12 hours and should arrive for the sample collection between 7:00 and 8:00 AM. The blood will be drawn through venipuncture. After collection, the sample will be centrifuged at 3000 revolutions per minute for five minutes. The serum will then be aliquoted for subsequent analyses. These serum samples will be stored at -20 degrees Celsius until they are analyzed. Insulin levels will be determined through the chemiluminescence technique using the Varioskan™ LUX multimode microplate reader. At the end of the six-month study, a second blood sample will be collected to assess insulin levels at that time.
Time frame
From enrollment to the end of treatment at 6 monthsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Coordinación de Investigación en Salud, Mexico
Lead sponsor
Hospital Infantil de Mexico Federico Gomez
Collaborator
Source ClinicalTrials.gov