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CompletedNCT03402698MeltDUpdated Jun 19, 2018

Vitamin D Supplementation in Children

An interventional study of cholecalciferol in Vitamin D Deficiency, sponsored by Children's Memorial Health Institute, Poland. Completed at 1 site in Poland. Open to participants aged 4 Years to 10 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2018-06-19.

Sponsored by Children's Memorial Health Institute, Poland · Not applicable, Interventional, and Prevention

Phase
Not applicable
Study type
Interventional
Enrollment
73
Allocation
Not applicable
Ages
4 Years to 10 Years
Sex
All
01

Study 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).

Read the 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
02

Conditions studied

  • Vitamin D Deficiency

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Keywords

  • cholecalciferol
  • BMI
  • winter
03

Who can participate

Ages eligible
4 Years to 10 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • Age 4-10 years; declaration of no use other preparations containing vitamin D; parental written informed consent

Exclusion criteria

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
04

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
73 participants (actual)

Study arms

  • Experimental
    cholecalciferol

    cholecalciferol at a dose 1000 IU /day for 3 months

    Dietary Supplement: cholecalciferol

Interventions

  • Dietary supplementcholecalciferol

    supplementation at a dose 1000 IU/d

05

What researchers measure

Primary outcomes

  1. serum 25-hydroxyvitamin D level

    after intervension vs baseline level

    Time frame: during 3 months of vitamin D supplementation

Secondary outcomes

  1. prevalence of vitamin D deficiency

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

    Time frame: during 3 months of vitamin D supplementation

  2. prevalence of vitamin D suficiency

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

    Time frame: during 3 months of vitamin D supplementation

06

Study locations

1 site
  • The Children's Memorial Health Institute
    Warsaw, 04-730, Poland
07

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT03402698
Lead sponsor
Children's Memorial Health Institute, Poland
Collaborators
Nutropharma Ltd.
Responsible party
Justyna Czech-Kowalska, Associate Professor (Deputy Head of Neonatal Department, Children's Memorial Health Institute, Poland) — Principal investigator
First posted
Jan 18, 2018
Start date
Jan 9, 2018
Primary completion
May 26, 2018
Completion
May 26, 2018
Last update
Jun 19, 2018

Study contacts

Justyna Czech-Kowalska
principal investigator · The Children's Memorial Health Institute

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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