Efficacy and Safety of Vitamin D Supplementation in Pediatric Patients with Obesity

NCT06847373 | Recruiting DMC

• 1 other identifier: R-2022-3603-018
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Vitamin D; Insulin Resistance; Obesity, Childhood

Keywords

vitamin D; insulin resistence; obesity; leptin; adiponectin; pediatric

Outcome Measures

Primary Outcomes (13)

• 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

  From enrollment to the end of treatment at 6 months

• 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.

  From enrollment to the end of treatment at 6 months

• 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.

  From enrollment to the end of treatment at 6 months

• 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.

  From enrollment to the end of treatment at 6 months

• Change from Baseline in HOMA-IR at 6 Months.

  The HOMA-IR index is utilized to evaluate the relationship between glucose and insulin, assessing insulin resistance. It is calculated using the formula: HOMA = (Glucose \* Insulin) / 405. At the end of the six-month study, At the end of the six-month study, the HOMA-IR index will be calculated again.

  From enrollment to the end of treatment at 6 months

• Change from Baseline in triglycerides at 6 Months.

  Triglycerides, a class of lipids, consist of one glycerol molecule bonded to three fatty acids. To determine triglyceride levels, a sample of peripheral blood will be collected from patients who must fast for 12 hours and arrive for sampling between 7:00 and 8:00 AM. The blood will be drawn through venipuncture, then centrifuged at 3000 revolutions per minute for five minutes, and the serum will be separated into aliquots for analysis. These samples will be stored at -20 degrees Celsius until tested. Triglyceride concentrations will be measured using a colorimetric method on the Varioskan™ LUX multimode microplate reader, an automated clinical chemistry analyzer. Triglyceride levels below 100 mg/dL in children under 10 years and below 130 mg/dL in individuals over 10 years are considered abnormal. At the end of the six-month study, a second blood sample will be collected to assess triglyceride levels at that time.

  From enrollment to the end of treatment at 6 months

• Change from Baseline in HDL cholesterol at 6 Months.

  High-density lipoprotein (HDL) cholesterol consists of smaller and denser lipoproteins, composed of a high proportion of proteins, and acts as a protective factor against cardiovascular disease. To determine HDL cholesterol levels, a peripheral blood sample will be collected from patients who are required to fast for 12 hours and arrive for sampling between 7:00 and 8:00 AM. Blood will be drawn through venipuncture, then centrifuged at 3000 revolutions per minute for five minutes. The serum will be separated into aliquots for subsequent analysis. These samples will be stored at -20 degrees Celsius until they are tested. HDL cholesterol levels will be measured using a colorimetric method on the Varioskan™ LUX multimode microplate reader, an automated clinical chemistry analyzer. Normal values are considered to \>40 mg/dL. At the conclusion of the six-month study, a second blood sample will be collected to reassess the HDL cholesterol levels.

  From enrollment to the end of treatment at 6 months

• Change from Baseline in LDL cholesterol at 6 Months.

  To determine Low-density lipoprotein (LDL) cholesterol, a peripheral blood sample will be collected from patients required to fast for 12 hours and arrive for sampling between 7:00 and 8:00 AM. Blood will be drawn via venipuncture and then centrifuged at 3000 revolutions per minute for five minutes. The serum will be separated into aliquots for subsequent analysis. These samples will be stored at -20 degrees Celsius until they are tested. LDL cholesterol levels will be measured using a colorimetric method on the Varioskan™ LUX multimode microplate reader, an automated clinical chemistry analyzer. Levels considered abnormal are \>130 mg/dL. At the end of the six-month study period, a second blood sample will be collected to reassess the LDL cholesterol levels.

  From enrollment to the end of treatment at 6 months

• Change from Baseline in total cholesterol at 6 Months.

  Total cholesterol is an essential molecule vital for life, performing crucial structural and metabolic functions in the human body. To measure total cholesterol levels, a peripheral blood sample will be collected from patients who must fast for 12 hours and arrive for sampling between 7:00 and 8:00 AM. Blood will be drawn through venipuncture, then centrifuged at 3000 revolutions per minute for five minutes. The serum will be separated into aliquots for further analysis. These samples will be stored at -20 degrees Celsius until they are tested. Total cholesterol levels will be determined using a colorimetric method with the Varioskan™ LUX multimode microplate reader, an automated clinical chemistry analyzer. Normal total cholesterol levels are considered to be less than 200 mg/dL. At the conclusion of the six-month study, a second blood sample will be collected to reassess total cholesterol levels.

  From enrollment to the end of treatment at 6 months

• Change from Baseline in glucose at 6 Months.

  Glucose is a vital molecule that provides energy to the body. To measure glucose levels, a peripheral blood sample will be collected from patients who must fast for 12 hours and arrive for sampling between 7:00 and 8:00 AM. Blood will be drawn through venipuncture, then centrifuged at 3000 revolutions per minute for five minutes. The serum will be separated into aliquots for further analysis. These samples will be stored at -20 degrees Celsius until they are tested. Glucose levels will be determined using a colorimetric method with the Varioskan™ LUX multimode microplate reader, an automated clinical chemistry analyzer. At the conclusion of the six-month study, a second blood sample will be collected to reassess glucose levels.

  From enrollment to the end of treatment at 6 months

• Change from Baseline in The Body Mass Index at 6 Months.

  The Body Mass Index (BMI): A measure of the relationship between an individual's weight and height. It will be determined using the formula: weight (kg) / height\^2 (m²). At the end of the six-month study, the BMI will be recalculated.

  From enrollment to the end of treatment at 6 months

• Change in the Z-score of the Body Mass Index at 6 Months.

  The Z-score of the Body Mass Index (BMI) is a statistical measurement that expresses the number of standard deviations a person's BMI is from the mean or average BMI of a population. This score is particularly useful in pediatric populations to assess how a child's body mass compares to that of their peers, considering age and gender. The calculation is based on national or global reference data that standardizes BMI according to age and sex. This standardized score helps to accurately identify and categorize underweight, healthy weight, overweight, and obesity in children and adolescents. At the start of the study, the BMI Z-score will be calculated to establish baseline levels for each participant. At the end of the six-month study period, the BMI Z-score will be recalculated to determine any changes.

  From enrollment to the end of treatment at 6 months

• Change in the leptin/adiponectin ratio at 6 months

  The leptin/adiponectin ratio represents the ratio of serum leptin to adiponectin levels. It will be determined through laboratory analysis after a 12-hour fasting period. Leptin and 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.Following the 6-month study period, a second blood sample will be taken.

  From enrollment to the end of treatment at 6 months

Study Arms (2)

Cholecalciferol 4000UI (Vitamin D)

EXPERIMENTAL

4000 IU daily orally during six months.

Dietary Supplement: Cholecalciferol

Cholecalciferol 1000U (Vitamin D)

SHAM COMPARATOR

1000 IU daily orally during six months. .

Dietary Supplement: Cholecalciferol

Interventions

Cholecalciferol DIETARY_SUPPLEMENT

cholecalciferol 4000 IU daily orally

Also known as: Vitamin D

Cholecalciferol 1000U (Vitamin D); Cholecalciferol 4000UI (Vitamin D)

Eligibility Criteria

• Age: 10 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Coordinación de Investigación en Salud, Mexico: lead
• Hospital Infantil de Mexico Federico Gomez: collaborator

Study Sites (1)

Hospital Infantil de Mexico Federico Gomez

México, 06720, Mexico

RECRUITING

MeSH Terms

Conditions

Insulin Resistance; Pediatric Obesity; Obesity

Interventions

Cholecalciferol; Vitamin D

Condition Hierarchy (Ancestors)

Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Overweight; Overnutrition; Nutrition Disorders; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Cholestenes; Cholestanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Sterols; Secosteroids; Membrane Lipids; Lipids

Central Study Contacts

JESSIE NALLELY Zurita-Cruz

CONTACT

5554194513; zuritajn@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Model Details: randomized double-blind clinical trial

Study Record Dates

• First Submitted: February 21, 2025
• First Posted: February 26, 2025
• Study Start: March 1, 2025
• Primary Completion: September 30, 2025
• Study Completion: October 30, 2025
• Last Updated: March 24, 2025

Record last verified: 2025-03

Locations

ME (1)