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Vitamin D Supplementation in Vitamin D Deficient Obese Children During Weight-loss Program

NCT02828228 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 200

Last updated 2016-07-11

No results posted yet for this study

Summary

1. Analyze the influence of vitamin D supplementation in obese children during weight-loss program on BMI, body composition and bone mineral density.
2. Analyze the influence of vitamin D supplementation on the risk profile of obesity-related complications, namely impaired tolerance of glucose, insulin resistance, dyslipidemia and arterial hypertension, in obese children participating in weight-loss program.
3. Analyze the prevalence of vitamin D deficiency among obese children.
4. Analyze the risk factors of vitamin D deficiency in obese children (age, gender, pubertal status).

Conditions

Interventions

DRUG

Vitamin D 1200 IU

Vitamin D 1200 IU once a day for 26 weeks

DRUG

Placebo

placebo once a day for 26 weeks

Sponsors & Collaborators

  • Nutricia Foundation

    collaborator OTHER

  • University Clinical Centre, Gdansk

    lead OTHER

Principal Investigators

  • Agnieszka Szlagatys-Sidorkiewicz, MD, PhD · University Clinical Centre, Gdansk

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
6 Years
Max Age
14 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-02-29
Primary Completion
2018-02-28
Completion
2019-02-28

Countries

  • Poland

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02828228 on ClinicalTrials.gov