Vitamin D Deficiency
Conditions
Keywords
cholecalciferol, BMI, winter
Brief summary
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
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: 1. 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. 2. 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) 3. Evaluation of vitamin D status depending on age, BMI and body composition. 4. 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: 1. 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) 2. Anthropometric measurements (body weight, height, BMI, assessment of body fat content - body composition by bioimpedance method- TANITA) 3. Assessment of vitamin D status (serum total 25OHD concentration in blood serum by immunochemiluminescence method) 4. Collecting data on the tolerability and safety of meliki ● tiki vitamin D including possible symptoms of vitamin D overdose
Interventions
DIETARY_SUPPLEMENTcholecalciferol
supplementation at a dose 1000 IU/d
Sponsors
Nutropharma Ltd.
Children's Memorial Health Institute, Poland
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
4 Years to 10 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| serum 25-hydroxyvitamin D level | during 3 months of vitamin D supplementation | after intervension vs baseline level |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| prevalence of vitamin D deficiency | during 3 months of vitamin D supplementation | serum 25-hydroxyvitamin D level \< 20ng/ml (after intervension vs baseline) |
| prevalence of vitamin D suficiency | during 3 months of vitamin D supplementation | serum 25-hydroxyvitamin D level \> 30ng/ml (after intervension vs baseline) |
Countries
Poland
Outcome results
None listed