OBEVIDOS “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.”

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Hospices Civils De Lyon

Participant type

Pediatric, Patients

Age range

0-17 years

Gender

Male and Female

Therapeutic area

Diseases [C] - Nutritional and Metabolic Diseases [C18]

Trial duration

24 Nov 2023 → ongoing

Decision date (initial)

2023-09-20

Transition trial

No

Low-intervention

Yes

Rare-disease indication

No

Vulnerable population

Yes

Funding sources

DGOS

External identifiers

EU CT number

2023-507089-18-00

ClinicalTrials.gov

NCT03516968

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Therapy, Efficacy, Safety

The primary objective is to compare the efficacy of two vitamin D supplementation regimens (monthly bolus substitution versus daily substitution), to increase serum vitamin D level in obese children and adolescents.

Secondary objectives 6

1. To evaluate safety and tolerance of both treatments
2. To evaluate compliance of both treatments
3. To describe influence of type of skin, physical activity, general health and sources of vitamin D on serum vitamin D level at M3 by treatment arm
4. To compare bone mineral density (DXA) at baseline for the subgroup > 10 years old with a preexisting cohort of healthy children and adolescents (healthy controls of the local VITADOS cohort)
5. To describe the bone mineral density (DXA) in obese children and adolescents at M0
6. To evaluate the variation of the PTH serum level between M0 and M3

Conditions and MedDRA coding

Obese children and adolescents

Study design 1 period

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 4

1. age ≥ 5 years and < 18 years
2. Obesity defined by BMI >97th percentile (>IOTF 30) for age and gender using WHO references
3. Assent of the patients and written consent of both parents/legal guardians
4. Patient affiliated to the national health system or benefiting from it

Exclusion criteria 12

1. Symptomatic vitamin D deficiency (tetany, muscular hypotonia, hypocalcaemic seizure)
2. Simultaneous enrolment to another study which could influence the results of the current study
3. Ongoing treatment with thiazides diuretics which reduce urinary excretion of calcium
4. Patient under legal protection or deprived of liberty
5. Signs of rickets at the X-ray (osteopenia and cortical thinning of the long bones, stress fractures, and metaphyseal widening and fraying)
6. 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 affecting vitamin D or phosphocalcium metabolism
7. Hypercalciuria (urinary Calcium/Creatinine > 0.7 mmol/mmol), calcium nephrolithiasis, hypervitaminosis D (25-(OH)D > 250 nmol/L); nephrocalcinosis;
8. Ongoing treatment with anticonvulsants/barbiturates or steroids which increase the catabolism of 25(OH)D
9. Contraindications to the class of drugs under study, e.g. known hypersensitivity or allergy to class of drugs or the investigational product
10. Pregnancy, breastfeeding
11. Inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, dementia, etc. of the participant
12. Vitamin D supplementation in the 3 months preceding the inclusion visit (V1)

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. Vitamin D (25(OH)D) serum level in each treatment arm (monthly bolus or daily supplementation), 3 months after the initiation of the treatment

Secondary endpoints 6

1. For blood samples at M0 and M3: vitamin D (25OHD serum level), calcium, phosphore. For urinary samples at M0 and M3: calcium, phosphore and urinary calcium/creatinine;
2. Amount of treatment taken compared to theoretical treatment quantity (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))
3. Type of skin (phototype), physical activity (physical activity questionnaire), sun exposure (sun exposure questionnaire), and alimentary intakes (Fardelonne and vitamin D intake questionnaires) at M0; and vitamin D (25(OH)D) serum level in each treatment arm at M3
4. Bone mineral density (DXA) for patients ≥ 10 years old at M0 and in comparison with data from healthy control (local VITADOS cohort).
5. Bone mineral density (DXA) at M0
6. Change in PTH serum level between M0 and M3

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Comparator 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Hospices Civils De Lyon

Sponsor organisation

Hospices Civils De Lyon

Address

3 Quai Des Celestins, Bp 2251 Bp 2251

City

Lyon Cedex 02

Postcode

69229

Country

France

Scientific contact point

Organisation

Hospices Civils De Lyon

Contact name

Dr Carine VILLANUEVA

Public contact point

Organisation

Hospices Civils De Lyon

Contact name

Dr Carine VILLANUEVA

Locations

1 EU/EEA country · 4 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 11 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

4 submissions — initial application plus substantial / non-substantial modifications