Vitamin D Deficiency Clinical Trial
Official title:
Effectiveness of Vitamin D Supplementation in the Prevention of Vitamin D Deficiency 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).
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
;
Status | Clinical Trial | Phase | |
---|---|---|---|
Active, not recruiting |
NCT04244474 -
Effect of Vitamin D Supplementation on Improvement of Pneumonic Children
|
Phase 1/Phase 2 | |
Recruiting |
NCT05459298 -
ViDES Trial (Vitamin D Extra Supplementation)
|
N/A | |
Suspended |
NCT03652987 -
Endocrine and Menstrual Disturbances in Women With Polycystic Ovary Syndrome (PCOS)
|
||
Completed |
NCT04476511 -
The Efficacy and the Safety of Vitamin D3 30,000 IU for Loading Dose Schedules
|
Phase 3 | |
Completed |
NCT03920150 -
Vitamin D 24'000 IU for Oral Intermittent Supplementation
|
Phase 3 | |
Completed |
NCT03264625 -
The Effects of Oral Vitamin D Supplementation on the Prevention of Peritoneal Dialysis-related Peritonitis
|
Phase 2 | |
Completed |
NCT04183257 -
Effect of Escalating Oral Vitamin D Replacement on HOMA-IR in Vitamin D Deficient Type 2 Diabetics
|
Phase 4 | |
Recruiting |
NCT05084248 -
Vitamin D Deficiency in Adults Following a Major Burn Injury
|
Phase 4 | |
Completed |
NCT05506696 -
Vitamin D Supplementation Study
|
N/A | |
Completed |
NCT00092066 -
A Study to Evaluate the Safety, Tolerability, and Efficacy of an Investigational Drug and Dietary Supplement in Men and Postmenopausal Women With Osteoporosis (0217A-227)
|
Phase 3 | |
Completed |
NCT03234218 -
Vitamin D Levels in Liver Transplantation Recipients Prospective Observational Study
|
||
Completed |
NCT02906319 -
Vitamin D and HbA1c Levels in Diabetic Patients With CKD
|
N/A | |
Completed |
NCT02714361 -
A Study to Investigate the Effect of Vitamin D3 Supplementation on Iron Status in Iron Deficient Women
|
N/A | |
Completed |
NCT03203382 -
Corneal Nerve Structure in Sjogren's
|
||
Completed |
NCT02118129 -
Vitamin D Among Young Adults: an Intervention Study Using a Mobile 'App'.
|
N/A | |
Completed |
NCT02187146 -
The Effects of Serum Vitamin D and IVF Outcome
|
N/A | |
Not yet recruiting |
NCT01419821 -
Vitamin D and Its Affect on Growth Rates and Bone Mineral Density Until Age 5
|
N/A | |
Completed |
NCT02275650 -
The Role of Narrowband Ultraviolet B Exposure in the Maintenance of Vitamin D Levels During Winter
|
N/A | |
Completed |
NCT01651000 -
Safety and Efficacy of CTAP101 to Treat Secondary Hyperparathyroidism in Stage 3 or 4 CKD and Vitamin D Insufficiency
|
Phase 3 | |
Completed |
NCT01688102 -
The Effect of Oral Vitamin D Versus Narrow-Band UV-B Exposure on the Lipid Profile
|
N/A |