NCT02828228

Brief Summary

  1. 1.Analyze the influence of vitamin D supplementation in obese children during weight-loss program on BMI, body composition and bone mineral density.
  2. 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. 3.Analyze the prevalence of vitamin D deficiency among obese children.
  4. 4.Analyze the risk factors of vitamin D deficiency in obese children (age, gender, pubertal status).

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
200

participants targeted

Target at P75+ for not_applicable obesity

Timeline
Completed

Started Feb 2016

Typical duration for not_applicable obesity

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2016

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

June 8, 2016

Completed
1 month until next milestone

First Posted

Study publicly available on registry

July 11, 2016

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2018

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2019

Completed
Last Updated

July 11, 2016

Status Verified

July 1, 2016

Enrollment Period

2 years

First QC Date

June 8, 2016

Last Update Submit

July 6, 2016

Conditions

Obesity

Keywords

obesityweight lossvitamin D deficiencybody composition

Outcome Measures

Primary Outcomes (1)

  • Bone mineral density

    Increase in bone mineral density during weight-loss program and vitamin D supplementation

    12 months

Secondary Outcomes (7)

  • Blood level of vitamin D

    12 months

  • Arterial blood pressure

    12 months

  • Lipid profile

    12 months

  • Oral Glucose Tolerance Test

    12 months

  • Chemerin

    12 months

  • +2 more secondary outcomes

Study Arms (2)

Vitamin D 1200 IU

EXPERIMENTAL

Supplementation with vitamin D (1200 IU) once a day for 26 weeks

Drug: Vitamin D 1200 IU

Placebo

PLACEBO COMPARATOR

Placebo once a day for 26 weeks

Drug: Placebo

Interventions

Vitamin D 1200 IUDRUG

Vitamin D 1200 IU once a day for 26 weeks

Also known as: cholecalciferol
Vitamin D 1200 IU
PlaceboDRUG

placebo once a day for 26 weeks

Placebo

Eligibility Criteria

Age6 Years - 14 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • overweight (BMI between the 85th and 95th percentile) or obesity (BMI \> 95th percentile), identified on the basis of anthropometric parameters
  • blood concentration of 25(OH)D3 \< 30 ng/ml
  • written consent of legal guardians

You may not qualify if:

  • Chronic conditions (asthma or allergies, inflammatory diseases of connective tissue, gastrointestinal disorders, diseases of kidneys and liver, disorders of bone metabolism)
  • Contraindications to administration of vitamin D
  • Administration of any preparation containing vitamin D, calcium, or steroid hormones during 3 months preceding the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

IUCCGdansk

Gdansk, Pomeranian Voivodeship, 80-210, Poland

RECRUITING

Related Publications (1)

  • Szlagatys-Sidorkiewicz A, Brzezinski M, Jankowska A, Metelska P, Slominska-Fraczek M, Socha P. Long-term effects of vitamin D supplementation in vitamin D deficient obese children participating in an integrated weight-loss programme (a double-blind placebo-controlled study) - rationale for the study design. BMC Pediatr. 2017 Apr 4;17(1):97. doi: 10.1186/s12887-017-0851-7.

    PMID: 28376768DERIVED

MeSH Terms

Conditions

ObesityWeight LossVitamin D Deficiency

Interventions

Vitamin DCholecalciferol

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsBody Weight ChangesAvitaminosisDeficiency DiseasesMalnutrition

Intervention Hierarchy (Ancestors)

SecosteroidsSteroidsFused-Ring CompoundsPolycyclic CompoundsCholestenesCholestanesSterolsMembrane LipidsLipids

Study Officials

  • Agnieszka Szlagatys-Sidorkiewicz, MD, PhD

    University Clinical Centre, Gdansk

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Magdalena Słominska-Frączek, MD,

CONTACT

694844420fraczek@gumed.edu.pl

Agnieszka Jankowska, MD, PhD

CONTACT

48606335246ajankowska@gumed.edu.pl

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 8, 2016

First Posted

July 11, 2016

Study Start

February 1, 2016

Primary Completion

February 1, 2018

Study Completion

February 1, 2019

Last Updated

July 11, 2016

Record last verified: 2016-07

Data Sharing

IPD Sharing
Will share

Locations

PL(1)