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.”

Conditions

Obese children and adolescents

Brief summary

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

Detailed description

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;, 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)), 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, Bone mineral density (DXA) for patients ≥ 10 years old at M0 and in comparison with data from healthy control (local VITADOS cohort)., Bone mineral density (DXA) at M0, Change in PTH serum level between M0 and M3

Related papers

No related papers found yet.

Interventions

DRUGZYMAD 50 000 UI

DRUGsolution buvable en ampoule

DRUGZYMAD 10 000 UI/ml

DRUGsolution buvable en gouttes

Eligibility

Sex/Gender

All

Age

0 Years to 17 Years

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
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;, 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)), 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, Bone mineral density (DXA) for patients ≥ 10 years old at M0 and in comparison with data from healthy control (local VITADOS cohort)., Bone mineral density (DXA) at M0, Change in PTH serum level between M0 and M3	—

Measure

Time frame

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;, 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)), 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, Bone mineral density (DXA) for patients ≥ 10 years old at M0 and in comparison with data from healthy control (local VITADOS cohort)., Bone mineral density (DXA) at M0, Change in PTH serum level between M0 and M3

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Countries

France

Outcome results

None listed