Vitamin D Supplementation in Children

Study Overview
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Brief Summary
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Prevalence of vitamin D deficiency in children in the northern country during winter season is very high (up to 90%). Vitamin D supplementation at a dose 600 -1000 IU/d is recommended in Polish children from September till April. However, there is shortage of studies in Polish children. The aim of the study is to assess the effectiveness of vitamin D supplementation in the prevention of vitamin D deficiency in Polish children (4-10 years of age).

Detailed Description
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Prevalence of vitamin D deficiency in children in the northern country during winter season is very high (up to 90%). Vitamin D supplementation at a dose 600 -1000 IU/d is recommended in Polish children from September till April. However, there is shortage of studies in Polish children. Aims: Assessment of the impact of vitamin D intake at a dose of 1000 IU / day on vitamin D status in children aged 4-10 years. Evaluation of the effectiveness of supply of vitamin D at a dose of 1000 IU / day in preventing vitamin D deficiency and maintaining optimal vitamin D status ( 25OHD level >30ng/ml) Evaluation of vitamin D status depending on age, BMI and body composition. Assessing the safety and tolerability of mel ● tiki vitamin D in children. Material: Children aged 4-10 years Study desing: Prospective intervention trial Intervention: cholecalciferol at a dose 1000 IU/day for 3 months Methods: Analysis of clinical characteristics (attendance at kindergarten / school, consumption of products rich in vitamin D, exposure to sun, use of sunblock's, the overall child's health (chronic diseases, medications, vitamins, micronutrients) Anthropometric measurements (body weight, height, BMI, assessment of body fat content - body composition by bioimpedance method- TANITA) Assessment of vitamin D status (serum total 25OHD concentration in blood serum by immunochemiluminescence method) Collecting data on the tolerability and safety of meliki ● tiki vitamin D including possible symptoms of vitamin D overdose

Official Title
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Effectiveness of Vitamin D Supplementation in the Prevention of Vitamin D Deficiency in Children.

Conditions
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Vitamin D Deficiency

Intervention / Treatment
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* Dietary Supplement: cholecalciferol


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age 4-10 years; declaration of no use other preparations containing vitamin D; parental written informed consent Exclusion Criteria: Osteoporosis, autoimmunological disorders, sarcoidosis, exacerbation of asthma, hypercalcemia, nephrolithiasis, renal insufficiency, nephrotic syndrome, cholestasis, hepatitis, diabetes typ 1, anticonvulsant treatment, prolonged treatment with steroids, cimetidine, ketoconazole, teophiline, diuretics, anti-tuberculosis drugs, participation in another clinical trial

Ages Eligible for Study
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Minimum Age: 4 Years
Maximum Age: 10 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: cholecalciferol<br>cholecalciferol at a dose 1000 IU /day for 3 months | Dietary Supplement: cholecalciferol<br>* supplementation at a dose 1000 IU/d<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| serum 25-hydroxyvitamin D level | after intervension vs baseline level | during 3 months of vitamin D supplementation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| prevalence of vitamin D deficiency | serum 25-hydroxyvitamin D level < 20ng/ml (after intervension vs baseline) | during 3 months of vitamin D supplementation | 
| prevalence of vitamin D suficiency | serum 25-hydroxyvitamin D level > 30ng/ml (after intervension vs baseline) | during 3 months of vitamin D supplementation | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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BMI, cholecalciferol, winter