Vitamin D Supplementation in Children

Not Applicable

Completed

• Conditions: Vitamin D Deficiency
• Interventions: Dietary Supplement: cholecalciferol

• Registration Number: NCT03402698
• Lead Sponsor: Children's Memorial Health Institute, Poland

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

Study Timeline

• Study Start: 2018-01-09
• Study First Submitted: 2018-01-11
• Study First Submitted QC: 2018-01-11
• Study First Posted: 2018-01-18
• Primary Completion: 2018-05-26
• Study Completion: 2018-05-26
• Status Verified: 2018-06
• Last Update Submitted: 2018-06-16
• Last Update Posted: 2018-06-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 73

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
cholecalciferol	cholecalciferol	cholecalciferol at a dose 1000 IU /day for 3 months

Primary Outcome Measures

Name	Time	Method
serum 25-hydroxyvitamin D level	during 3 months of vitamin D supplementation	after intervension vs baseline level

Secondary Outcome Measures

Name	Time	Method
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)

Trial Locations

Locations (1)

The Children's Memorial Health Institute; 🇵🇱 Warsaw, Poland