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Trial record 49 of 123 for:    hypertension "vitamin d"

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

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ClinicalTrials.gov Identifier: NCT03516968
Recruitment Status : Not yet recruiting
First Posted : May 7, 2018
Last Update Posted : May 7, 2018
Sponsor:
Information provided by (Responsible Party):
Hospices Civils de Lyon

Brief Summary:

Childhood obesity prevalence is increasing and is a serious public health challenge. Indeed, according to INPES in 2006, overweight and obesity were affecting 18 % of French children between 3 and 17 years. 3 % of the boys and 4 % of the girls were classified as obese. Obese children are likely to develop chronic disease, starting at paediatric age, as cardiovascular or bone diseases, or type 2 diabetes.

Vitamin D deficiency is recognized to play an essential role in bone metabolism and arterial hypertension and type 2 diabetes development.

Obesity, in adults like in children, is associated with vitamin D deficiency. Common explanations for this low serum concentration of 25(OH)D in obese are the sequestration and/or the volumetric dilution of this lipid-soluble vitamin by adipose tissue. Therefore, obese population is at higher risk of developing cardiovascular and metabolic complications.

The nutrition comity of French Pediatric Society (SFP) edit vitamin D supplementation recommendations (2012) for adolescents at risk of deficit: supplementation by trimestral loading dose of 80 000 to 100 000 UI of vitamin D. However, for obese patients, the deficit is difficult to cure with classical loading doses. It seems that these patients need higher dose of Vitamin D (two to three times higher). Likewise, the optimum scheme of administration (daily vs monthly) was never evaluated.

Given new physiopathological data on pleiotropic role of vitamin D (on bone, cardiovascular system, adipose tissue) and in light of consequence of obesity on these systems, it seems essential to obtain data on vitamin deficit correction in obese children and adolescents and to evaluate bone status of these patients using modern imaging technics (high resolution peripheral quantitative computed tomography, HRpQCT).

In this context, the OBEVIDOS study, randomised multi-centre prospective in 156 obese children and adolescent will allow us for :

  • evaluate vitamin D correction effect by two scheme of administration
  • establish an inventory of vitamin D status in this population
  • Modeling and simulation of vitamin D concentration in obese children and adolescents using a mathematical PBPK model
  • study, in a patient sub-group, the impact of vitamin D deficit and of obesity by itself on bone, by analysing bone micro-architecture

Condition or disease Intervention/treatment Phase
Obesity, Childhood Drug: Monthly bolus of cholecalciferol per os Drug: Daily dose of cholecalciferol per os Other: Control Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 156 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Treatment of Vitamin D Deficit in Obese Children and Adolescents: a Multi-centre Open Label Randomized Controlled Study Comparing the Efficacy of Two Oral Supplementation Regimens: Monthly Boluses Versus Daily Doses for Correcting Blood Vitamin D Level. A French-Swiss Collaboration
Estimated Study Start Date : September 2018
Estimated Primary Completion Date : January 2022
Estimated Study Completion Date : January 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Vitamin D
Drug Information available for: Vitamin D

Arm Intervention/treatment
Experimental: Monthly bolus arm Drug: Monthly bolus of cholecalciferol per os
Bolus therapy (100'000 - 200'000 IU/month depending on age: < or ≥ 9 years old) for 3 months

Active Comparator: Daily arm Drug: Daily dose of cholecalciferol per os
Daily substitution (3'500 to 6'500 IU/day depending on age: < or ≥ 9 years old) for 3 months

Control group
Group of obese patients without vitamin D deficiency
Other: Control
no cholecalciferol therapy




Primary Outcome Measures :
  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 4 ]

Secondary Outcome Measures :
  1. calcium dosages [ Time Frame: Month 4 ]
    blood safety dosages

  2. phosphore dosages [ Time Frame: Month 4 ]
    blood safety dosages

  3. urinary calcium [ Time Frame: Month 4 ]
    urinary safety dosages

  4. creatinin [ Time Frame: Month 4 ]
    urinary safety dosages

  5. Treatment compliance [ Time Frame: Month 4 ]
  6. Evaluation of influence of type of skin on study results [ Time Frame: Month 4 ]
    assessed by Fitzpatrick scale

  7. Evaluation of influence of sun exposure on study results [ Time Frame: Month 4 ]
    assessed by a questionnaire

  8. Evaluation of influence of physical activity on study results [ Time Frame: Month 4 ]
    assessed by a questionnaire

  9. Evaluation of influence of alimentary intakes on study results [ Time Frame: Month 4 ]
    assessed by questionnaires

  10. Modeling of vitamin D concentration [ Time Frame: Month 4 ]
    Modeling and simulation of vitamin D concentration in obese children and adolescents using a mathematical PBPK model

  11. Evaluation of one mineral density by biphotonic absorptiometry in the spine [ Time Frame: Day 1 ]
    Comparison of the both treated arms with the control group

  12. Evaluation of one mineral density by biphotonic absorptiometry in the femoral neck [ Time Frame: Day 1 ]
    Comparison of the both treated arms with the control group

  13. Evaluation of bone micro-architecture (HRpQCT) at the radius [ Time Frame: Day 1 ]
    Comparison of the both treated arms with the control group

  14. Evaluation of bone micro-architecture (HRpQCT) at the tibia [ Time Frame: Day 1 ]
    Comparison of the both treated arms with the control group



Information from the National Library of Medicine

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Ages Eligible for Study:   5 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Aged between 5 to 18 year-old
  • Being obese (BMI >97th percentile 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:

  • They suffer from symptomatic vitamin D deficiency (tetany, muscular hypotonia, hypocalcaemic seizure) or present signs of rickets at the X-ray (osteopenia and cortical thinning of the long bones, stress fractures, and metaphyseal widening and fraying. The earliest rachitic change is a loss of demarcation between the metaphysic and growth plate and loss of the provisional zone of calcification). A 10-point radiographic scoring system will be used to assess the presence and the severity of rickets on the basis of knee and wrist findings.
  • They suffer from a chronic disease such as granulomatous conditions, Williams syndrome, or hypothyroidism predisposing to hypocalcaemia or in case of hypercalcaemia, liver/kidney disease, malabsorption diseases.
  • They are under treatment of anticonvulsivants/barbiturates or steroids which increase the catabolism of 25(OH)D.
  • Contraindications to the class of drugs under study, e.g. known hypersensitivity or allergy to class of drugs or the investigational product.
  • Pregnancy.
  • Inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, dementia, etc. of the participant.
  • Previous enrolment into the current study

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03516968


Contacts
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Contact: Carine Villanueva, MD 4 27 85 53 28 ext +33 carine.villanueva@chu-lyon.fr
Contact: Tiphanie Ginhoux 427 857 723 ext +33 tiphanie.ginhoux@chu-lyon.fr

Sponsors and Collaborators
Hospices Civils de Lyon
Investigators
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Principal Investigator: Carine Villanueva Hospices Civils de Lyon

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Responsible Party: Hospices Civils de Lyon
ClinicalTrials.gov Identifier: NCT03516968     History of Changes
Other Study ID Numbers: 69HCL18_0148
First Posted: May 7, 2018    Key Record Dates
Last Update Posted: May 7, 2018
Last Verified: April 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Hospices Civils de Lyon:
Obesity
Vitamin D deficiency,
supplementation,
Child
Adolescent

Additional relevant MeSH terms:
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Vitamin D
Pediatric Obesity
Obesity
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms
Vitamins
Ergocalciferols
Cholecalciferol
Micronutrients
Nutrients
Growth Substances
Physiological Effects of Drugs
Bone Density Conservation Agents
Calcium-Regulating Hormones and Agents