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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

Where this study stands

Counted across the records on this site · 2026-11-12

Among 228 studies testing cholecalciferol in Vitamin D Deficiency — 9 open to participants now, 16 under way, 2 of them phase 3. Cholecalciferol · Vitamin D Deficiency.

Enrollment
114th of 228
73 · median 72
Started
2018
with 15 others
No phase
113 of 228
6 open now
Registered
162nd of 228
by date

Among the 228 studies testing cholecalciferol in Vitamin D Deficiency, this one is the 114th largest by enrollment, is one of 16 that started in 2018, is one of 113 with no phase, and was the 162nd registered.

Vitamin D Deficiency

801 studies on the registry are indexed under Vitamin D Deficiency; 60 are open to participants now.

Browse Vitamin D Deficiency studies →

Open to participants now

9 of the 228 studies testing cholecalciferol in Vitamin D Deficiency are open now, in 7 countries. Recruiting first, the newest first:

4 more — sign in →

By country, each count listing its studies:

All 9 open studies →

About cholecalciferol

Cholecalciferol: first FDA approval 2000 (INFUVITE ADULT), first EMA approval 2005. What it is approved for, and how studies give it, is on its page →

Who these studies take

Of the 37 Vitamin D Deficiency studies recruiting now, 16 (43%) set no upper age limit and 18 (49%) stop at 75 or younger; 10 take children under 18; 11 take healthy volunteers.

This study: 4 Years to 10 Years · all sexes · healthy volunteers too.

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Watch this landscapeDownload CSVNarrow it in search →With an account: a weekly mail of what changed among 228 studies testing cholecalciferol in Vitamin D Deficiency, or all of them as a file.
02

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
03

Conditions studied

  • Vitamin D Deficiency

Browse trials for

Keywords

  • cholecalciferol
  • BMI
  • winter
04

Who can participate

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

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

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 , cimetidine, ketoconazole, teophiline, diuretics, anti-tuberculosis drugs, participation in another clinical trial
Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Corticosteroids (steroids)

Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.

Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.

05

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

06

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

07

Study locations

1 site
  • The Children's Memorial Health Institute
    Warsaw, 04-730, Poland
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Jan 2018 to primary completion in May 2018, 4 months.

Of 168 non-industry interventional studies with no phase under Vitamin D Deficiency, half reached primary completion within 11 months of starting (the median), counting those still running; a quarter within 4 and three quarters within 29. This study's 4 months is below that.

Counting every sponsor, half of 170 studies reached it within 11 months; a quarter within 4 and three quarters within 29.

How these figures are worked out, and which studies are left out of them.

Registered
Jan 11, 2018
First posted
Jan 18, 2018
StartActual
Jan 9, 2018
Primary completionActual
May 26, 2018
CompletionActual
May 26, 2018
Last update
Jun 19, 2018
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jun 19, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

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 ↗

Not currently enrolling

This study is completed, as verified in Jun 2018. You cannot join it, but the record below documents what was studied.

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Discussion

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Studies of the drug tested here: Cholecalciferol

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