Monthly Boluses Versus Daily Doses for Correcting Blood Vitamin D Deficit in Obese Children and Adolescents (OBEVIDOS)

June 10, 2025 updated by: Hospices Civils de Lyon

Treatment of Vitamin D Deficit in Obese Children and Adolescents: an Open Label Randomized Controlled Study Comparing the Efficacy of Two Oral Supplementation Regimens: Monthly Boluses Versus Daily Doses for Correcting Blood Vitamin D Level: OBEVIDOS

Childhood obesity is one of the most serious public health challenges of the 21st century, with an increasing prevalence over time in developed countries. Overweight and obese children and adolescents are likely to remain so into adulthood and to develop chronic diseases at a young age, such as diabetes and cardiovascular disease.

Obese patients, whether adults or children, are likely to have low serum vitamin D levels due to sequestration and/or volumetric dilution of this fat-soluble vitamin in adipose tissue. Studies have established a link between vitamin D deficiency or insufficiency and chronic diseases such as hypertension, type 2 diabetes and other metabolic problems.

Determining physiological 25(OH)D levels to ensure optimal phosphocalcic metabolism and bone mineralisation requires the use of functional markers: parathyroid hormone (PTH) levels, assessment of the intestinal calcium absorption fraction, assessment of bone mineral density and bone mineral content using absorptiometry.

Vitamin D deficiency leads to malabsorption of calcium and phosphate in the digestive tract, with concentrations, especially of calcium, tending to fall in plasma, resulting in hypersecretion of PTH, which mobilises bone calcium to maintain subnormal blood calcium levels.

Each unit increase in BMI is associated with lower serum vitamin D concentrations: given these low concentrations in this population associated with the risk of developing pathologies, it is important to ensure adequate vitamin D supplementation.

The latest paediatric recommendations recommend, for children aged between 1 and 18 with vitamin D deficiency, a supplement of 2,000 IU/day for at least 6 weeks or a bolus of 50,000 IU once a week for at least 6 weeks.

There are different dosage regimens for the replacement of vitamin D deficiency depending on the country: there is a lack of data on the appropriate dosage and administration regimens for vitamin D supplementation in cases of deficiency, particularly in obese children and adolescents. A prospective, randomised clinical trial will make it possible to define the vitamin D supplementation regimen best suited to increasing serum vitamin D levels in these children and adolescents suffering from obesity.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

68

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • France
      • Bron, France, 69677
        • Recruiting
        • Centre d'Investigation Clinique de LYON - CIC 1407- Groupement Hospitalier Est / Hospices Civils de Lyon
        • Contact:
        • Principal Investigator:
          • Aurélie PORTEFAIX, Dr
      • Bron, France, 69677
        • Recruiting
        • Service d'endocrinologie et métabolisme pédiatrique, Hôpital Femme Mère Enfant
        • Contact:
        • Principal Investigator:
          • Carinne VILLANUEVA, Dr
      • Clermont-Ferrand, France, 63000
        • Not yet recruiting
        • Service d'Endocrinologie Pédiatrique CHU de Clermont-Ferrand
        • Contact:
        • Principal Investigator:
          • Charlotte CARDENOUX, Dr
      • Romagnat, France, 63540
        • Not yet recruiting
        • Centre Médical Infantile de Romagnat
        • Principal Investigator:
          • Charlotte CARDENOUX, Dr
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

5 years to 18 years (Child, Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Aged between 5 to 18 year-old
  • Being obese (BMI >97th percentile, > IOTF 30, for age and gender using the WHO references)
  • Patients (parents) having given their informed consent
  • Patient having insurance from the national health system

Exclusion Criteria:

Children will be excluded from the study if:

  • Symptomatic vitamin D deficiency (tetany, muscular hypotonia, hypocalcaemic seizure)
  • Vitamin D supplementation in the 3 months preceding the inclusion visit (V1)
  • Signs of rickets at the X-ray (osteopenia and cortical thinning of the long bones, stress fractures, and metaphyseal widening and fraying)
  • Chronic disease such as granulomatous conditions, Williams syndrome, or hypothyroidism predisposing to hypocalcaemia or in case of hypercalcaemia (calcium > 2.65 mmol/L), liver/kidney disease, malabsorption diseases;
  • Hypercalciuria (urinary Calcium/Creatinine > 0.7 mmol/mmol), calcium nephrolithiasis, hypervitaminosis D (25-(OH)D > 250 nmol/L); nephrocalcinosis;
  • Ongoing treatment with anticonvulsants/barbiturates or steroids which increase the catabolism of 25(OH)D;
  • Ongoing treatment with thiazides diuretics which reduce urinary excretion of calcium;
  • Contraindications to the class of drugs under study, e.g. known hypersensitivity or allergy to class of drugs or the investigational product;
  • Pregnancy, breastfeeding;
  • Inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, dementia, etc. of the participant;
  • Simultaneous enrolment to another study which could influence the results of the current study;
  • Patient under legal protection or deprived of liberty.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Monthly bolus arm
Drug: Monthly bolus of cholecalciferol per os
Bolus therapy: first 50 000 IU and a second 50 IU after 6 weeks
Experimental: Daily arm
Drug: Daily dose of cholecalciferol per os
Daily substitution, 1200 IU per day (4 drops), for 3 months

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Proportion of patients reaching the therapeutic target defined as vitamin D (25(OH)D) serum level ≥ 50 nmol/L and < 120 nmol/L
Time Frame: Month 3
Vitamin D (25OH)D) serum level
Month 3

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
calcium dosages
Time Frame: Month 3
blood safety dosages
Month 3
phosphore dosages
Time Frame: Month 3
blood safety dosages
Month 3
vitamin D (25(OH)D) dosages
Time Frame: Month 3
blood safety dosages
Month 3
urinary calcium
Time Frame: Month 3
urinary safety dosages
Month 3
creatinin
Time Frame: Month 3
urinary safety dosages
Month 3
Treatment compliance
Time Frame: Month 3
amount of treatment taken (Daily arm: patient diary and weighting of returned treatment at M3. Bolus arm: description of taken ampoules after hospital dosing (number taken, empty or not))
Month 3
Evaluation of influence of type of skin on study results
Time Frame: Month 3
assessed a questionnaire
Month 3
Evaluation of influence of physical activity on study results
Time Frame: Month 3
assessed by a questionnaire
Month 3
Evaluation of influence of sun exposure on study results
Time Frame: Month 3
assessed by a questionnaire
Month 3
Evaluation of influence of alimentary intakes on study results
Time Frame: Month 3
assessed by questionnaires
Month 3
Bone mineral density description (DXA)
Time Frame: Day 1
Bone mineral density
Day 1
Evaluation of the PTH variation
Time Frame: Month 3
PTH serum level
Month 3
Comparison bone mineral density (DXA) with a preexisting cohort
Time Frame: Day 1
Bone mineral density (DXA)
Day 1

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hospices Civils de Lyon

Investigators

  • Principal Investigator: Carine Villanueva, Hospices Civils de Lyon

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 4, 2023

Primary Completion (Estimated)

March 1, 2027

Study Completion (Estimated)

March 1, 2027

Study Registration Dates

First Submitted

April 24, 2018

First Submitted That Met QC Criteria

April 24, 2018

First Posted (Actual)

May 7, 2018

Study Record Updates

Last Update Posted (Actual)

June 13, 2025

Last Update Submitted That Met QC Criteria

June 10, 2025

Last Verified

June 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 69HCL18_0148

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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