Vitamin D Supplementation in Children (MeltD)

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).

Study Overview

• Status: Completed
• Conditions: Vitamin D Deficiency
• Intervention / Treatment: Dietary supplement: cholecalciferol

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

• Study Type: Interventional
• Enrollment (Actual): 73
• Phase: Not Applicable

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 4 years to 10 years (Child)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: cholecalciferol; cholecalciferol at a dose 1000 IU /day for 3 months	Dietary supplement: cholecalciferol; supplementation at a dose 1000 IU/d

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
serum 25-hydroxyvitamin D level	after intervension vs baseline level	during 3 months of vitamin D supplementation

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
prevalence of vitamin D deficiency	serum 25-hydroxyvitamin D level < 20ng/ml (after intervension vs baseline)	during 3 months of vitamin D supplementation
prevalence of vitamin D suficiency	serum 25-hydroxyvitamin D level > 30ng/ml (after intervension vs baseline)	during 3 months of vitamin D supplementation

Collaborators and Investigators

• Sponsor: Children's Memorial Health Institute, Poland
• Collaborators: Nutropharma Ltd.
• Investigators: Principal Investigator: Justyna Czech-Kowalska, The Children's Memorial Health Institute

Study record dates

Study Major Dates

• Study Start (Actual): January 9, 2018
• Primary Completion (Actual): May 26, 2018
• Study Completion (Actual): May 26, 2018

Study Registration Dates

• First Submitted: January 11, 2018
• First Submitted That Met QC Criteria: January 11, 2018
• First Posted (Actual): January 18, 2018

Study Record Updates

• Last Update Posted (Actual): June 19, 2018
• Last Update Submitted That Met QC Criteria: June 16, 2018
• Last Verified: June 1, 2018

More Information

Terms related to this study

• Keywords: winter; BMI; cholecalciferol
• Additional Relevant MeSH Terms: Nutrition Disorders; Avitaminosis; Deficiency Diseases; Malnutrition; Vitamin D Deficiency; Physiological Effects of Drugs; Micronutrients; Vitamins; Bone Density Conservation Agents; Calcium-Regulating Hormones and Agents; Vitamin D; Cholecalciferol
• Other Study ID Numbers: meltiki D/09/2017

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No