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Completed

NCT Number: NCT03402698

Vitamin D Supplementation in Children

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).

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Key information

Age range

4 year–10 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The Children's Memorial Health Institute

Warsaw, 04-730, Poland

About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Cholecalciferol

Dietary Supplement

supplementation at a dose 1000 IU/d

Primary outcomes

  1. serum 25-hydroxyvitamin D level

    Time frame: during 3 months of vitamin D supplementation

    after intervension vs baseline level

Secondary outcomes

  1. prevalence of vitamin D deficiency

    Time frame: during 3 months of vitamin D supplementation

    serum 25-hydroxyvitamin D level < 20ng/ml (after intervension vs baseline)

  2. prevalence of vitamin D suficiency

    Time frame: during 3 months of vitamin D supplementation

    serum 25-hydroxyvitamin D level > 30ng/ml (after intervension vs baseline)

Sponsors and collaborators

Lead sponsor

Children's Memorial Health Institute, Poland

Other

Collaborators

  • NutroPharma

Registry information

Official study title

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

Acronym: MeltD

Important dates

Study start
2018
Primary completion
2018
Study completion
2018
First posted
Jan 18, 2018
Registry last updated
Jun 19, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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