2023-507089-18-00招募中3 期
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.”
Hospices Civils De Lyon, Hospices Civils De Lyon3 个研究点 分布在 1 个国家目标入组 68 人开始时间: 2023年9月20日最近更新:
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 68
- 试验地点
- 3
- 主要终点
- Vitamin D (25(OH)D) serum level in each treatment arm (monthly bolus or daily supplementation), 3 months after the initiation of the treatment
研究概览
简要总结
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.
研究设计
- 分配方式
- Randomized
- 主要目的
- Cholécalciférol
- 盲法
- None
入排标准
- 年龄范围
- 0 years 至 17 years（0-17 Years）
- 接受健康志愿者
- 是
入选标准
- •age ≥ 5 years and < 18 years
- •Obesity defined by BMI >97th percentile (>IOTF 30) for age and gender using WHO references
- •Assent of the patients and written consent of both parents/legal guardians
- •Patient affiliated to the national health system or benefiting from it
排除标准
- •Symptomatic vitamin D deficiency (tetany, muscular hypotonia, hypocalcaemic seizure)
- •Pregnancy, breastfeeding
- •Inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, dementia, etc. of the participant
- •Vitamin D supplementation in the 3 months preceding the inclusion visit (V1)
- •Simultaneous enrolment to another study which could influence the results of the current study
- •Ongoing treatment with thiazides diuretics which reduce urinary excretion of calcium
- •Patient under legal protection or deprived of liberty
- •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
- •Contraindications to the class of drugs under study, e.g. known hypersensitivity or allergy to class of drugs or the investigational product
结局指标
主要结局
Vitamin D (25(OH)D) serum level in each treatment arm (monthly bolus or daily supplementation), 3 months after the initiation of the treatment
Vitamin D (25(OH)D) serum level in each treatment arm (monthly bolus or daily supplementation), 3 months after the initiation of the treatment
次要结局
- 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
研究者
Dr Carine VILLANUEVA
Scientific
Hospices Civils De Lyon
研究点 (3)
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