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NCT Number: NCT03516968

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

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.

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Key information

Age range

5 year–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Centre d'Investigation Clinique de LYON - CIC 1407- Groupement Hospitalier Est / Hospices Civils de Lyon, Bron, France

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Monthly bolus of cholecalciferol per os

Drug

Bolus therapy: first 50 000 IU and a second 50 IU after 6 weeks

Daily dose of cholecalciferol per os

Drug

Daily substitution, 1200 IU per day (4 drops), for 3 months

Primary outcomes

  1. 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

Secondary outcomes

  1. calcium dosages

    Time frame: Month 3

    blood safety dosages

  2. phosphore dosages

    Time frame: Month 3

    blood safety dosages

  3. vitamin D (25(OH)D) dosages

    Time frame: Month 3

    blood safety dosages

  4. urinary calcium

    Time frame: Month 3

    urinary safety dosages

  5. creatinin

    Time frame: Month 3

    urinary safety dosages

  6. 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))

  7. Evaluation of influence of type of skin on study results

    Time frame: Month 3

    assessed a questionnaire

  8. Evaluation of influence of physical activity on study results

    Time frame: Month 3

    assessed by a questionnaire

  9. Evaluation of influence of sun exposure on study results

    Time frame: Month 3

    assessed by a questionnaire

  10. Evaluation of influence of alimentary intakes on study results

    Time frame: Month 3

    assessed by questionnaires

  11. Bone mineral density description (DXA)

    Time frame: Day 1

    Bone mineral density

  12. Evaluation of the PTH variation

    Time frame: Month 3

    PTH serum level

  13. Comparison bone mineral density (DXA) with a preexisting cohort

    Time frame: Day 1

    Bone mineral density (DXA)

Study contacts

Contact information is provided by the study sponsor or research team.

Carine Villanueva, MD

CONTACT

[email protected]

4 27 85 53 28 ext. +33

Sponsors and collaborators

Lead sponsor

Hospices Civils de Lyon

Other

Registry information

Official study 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

Acronym: OBEVIDOS

Important dates

Study start
2023
Primary completion
2027
Study completion
2027
First posted
May 7, 2018
Registry last updated
Jun 13, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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