Vitamin D Supplementation in Children

NCT03402698 | Completed

• 1 other identifier: meltiki D/09/2017
• Study Type: interventional
• Target: 73
• Locations: 1 country
• Sites: 1

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).

Conditions

Vitamin D Deficiency

Keywords

cholecalciferol; BMI; winter

Outcome Measures

Primary Outcomes (1)

• serum 25-hydroxyvitamin D level

  after intervension vs baseline level

  during 3 months of vitamin D supplementation

Secondary Outcomes (2)

• prevalence of vitamin D deficiency

  during 3 months of vitamin D supplementation

• prevalence of vitamin D suficiency

  during 3 months of vitamin D supplementation

Study Arms (1)

cholecalciferol

EXPERIMENTAL

cholecalciferol at a dose 1000 IU /day for 3 months

Dietary Supplement: cholecalciferol

Interventions

cholecalciferol DIETARY_SUPPLEMENT

supplementation at a dose 1000 IU/d

cholecalciferol

Eligibility Criteria

• Age: 4 Years - 10 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Children's Memorial Health Institute, Poland: lead
• Nutropharma Ltd.: collaborator

Study Sites (1)

The Children's Memorial Health Institute

Warsaw, 04-730, Poland

Location

MeSH Terms

Conditions

Vitamin D Deficiency

Interventions

Cholecalciferol

Condition Hierarchy (Ancestors)

Avitaminosis; Deficiency Diseases; Malnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Cholestenes; Cholestanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Sterols; Vitamin D; Secosteroids; Membrane Lipids; Lipids

Study Officials

• Justyna Czech-Kowalska

  The Children's Memorial Health Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Deputy Head of Neonatal Department

Study Record Dates

• First Submitted: January 11, 2018
• First Posted: January 18, 2018
• Study Start: January 9, 2018
• Primary Completion: May 26, 2018
• Study Completion: May 26, 2018
• Last Updated: June 19, 2018

Record last verified: 2018-06

Data Sharing

• IPD Sharing: Will not share

Locations

PL (1)