Obesity, ChildhoodPhase 3OBEVIDOSNCT03516968
Monthly Boluses Versus Daily Doses for Correcting Blood Vitamin D Deficit in Obese Children and Adolescents
A Phase 3 study testing Monthly bolus of cholecalciferol per os and Daily dose of cholecalciferol per os in people with Obesity, Childhood, run by Hospices Civils de Lyon at 4 sites in France.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 5 to 18 years
- Conditions the study is for
- Obesity, Childhood
- What is being tested?
- Monthly bolus of cholecalciferol per os and Daily dose of cholecalciferol per os
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 68 participants
- Where
- 4 sitesFrance
- Study dates
- 4 Dec 2023to Mar 2027
- Phase
- Phase 3
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 5 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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
Who cannot join
- 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;
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- 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.
Trial locations and contacts
4 sites in 1 country. Contact the study team or a site near you to ask about taking part.
France4 sites, 4 recruiting
- Recruiting
Centre d'Investigation Clinique de LYON - CIC 1407- Groupement Hospitalier Est / Hospices Civils de Lyon
Bron, 69677
Aurélie PORTEFAIX, Dr, 04.72.35.75.51 ext. +33, aurelie.portefaix@chu-lyon.fr
Aurélie PORTEFAIX, Dr
- Recruiting
Service d'endocrinologie et métabolisme pédiatrique, Hôpital Femme Mère Enfant
Bron, 69677
Carinne VILLANUEVA, Dr, 04 27 85 53 28 ext. +33, carine.villanueva@chu-lyon.fr
Carinne VILLANUEVA, Dr
- Not yet recruiting
Service d'Endocrinologie Pédiatrique CHU de Clermont-Ferrand
Clermont-Ferrand, 63000
Charlotte CARDENOUX, Dr, 04 73 75 00 00 ext. +33, ccardenoux@chu-clermontferrand.fr
Charlotte CARDENOUX, Dr
- Not yet recruiting
Centre Médical Infantile de Romagnat
Romagnat, 63540
Charlotte CARDENOUX, Dr, 04 73 62 76 17 ext. +33, c.cardenoux@centremedicalinfantile.com
Charlotte CARDENOUX, Dr
About this study
Official title: 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.
Read more
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.
- Conditions
- Obesity, Childhood
- Being tested
- Monthly bolus of cholecalciferol per os, Daily dose of cholecalciferol per os
- Keywords
- Obesity, Vitamin D deficiency,, supplementation,, Child, Adolescent
- Medical subject headings
- Pediatric Obesity, Obesity, Vitamin D Deficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Monthly bolus of cholecalciferol per osDrug
Bolus therapy: first 50 000 IU and a second 50 IU after 6 weeks
Daily dose of cholecalciferol per osDrug
Daily substitution, 1200 IU per day (4 drops), for 3 months
| Study group | Role | What they receive |
|---|---|---|
| Monthly bolus arm | Experimental | Not described Receives: Drug: Monthly bolus of cholecalciferol per os |
| Daily arm | Experimental | Not described Receives: Drug: Daily dose of cholecalciferol per os |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of patients reaching the therapeutic target defined as vitamin D (25(OH)D) serum level ≥ 50 nmol/L and < 120 nmol/L
Vitamin D (25OH)D) serum level
Measured: Month 3
Secondary outcomes (13)
calcium dosages
blood safety dosages
Measured: Month 3
phosphore dosages
blood safety dosages
Measured: Month 3
vitamin D (25(OH)D) dosages
blood safety dosages
Measured: Month 3
urinary calcium
urinary safety dosages
Measured: Month 3
creatinin
urinary safety dosages
Measured: Month 3
Treatment compliance
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))
Measured: Month 3
Evaluation of influence of type of skin on study results
assessed a questionnaire
Measured: Month 3
Evaluation of influence of physical activity on study results
assessed by a questionnaire
Measured: Month 3
Evaluation of influence of sun exposure on study results
assessed by a questionnaire
Measured: Month 3
Evaluation of influence of alimentary intakes on study results
assessed by questionnaires
Measured: Month 3
Bone mineral density description (DXA)
Bone mineral density
Measured: Day 1
Evaluation of the PTH variation
PTH serum level
Measured: Month 3
Comparison bone mineral density (DXA) with a preexisting cohort
Bone mineral density (DXA)
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 May 2018
- Study start4 Dec 2023
- Primary completionMar 2027 (estimated)
- Study completionMar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obesity, ChildhoodStudies of the same condition, open and under way.
- More trials run by Hospices Civils de LyonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 68 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Carine Villanueva, Principal investigator, Hospices Civils de Lyon
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03516968
- Sponsor's protocol ID
- 69HCL18_0148
- Acronym
- OBEVIDOS
- Status last verified
- Jun 2025
- First submitted
- 24 Apr 2018
- Last updated
- 13 Jun 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No