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

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ClinicalTrials.gov Identifier: NCT02828228
Recruitment Status : Unknown
Verified July 2016 by University Clinical Centre, Gdansk.
Recruitment status was:  Recruiting
First Posted : July 11, 2016
Last Update Posted : July 11, 2016
Sponsor:
Collaborator:
Nutricia Foundation
Information provided by (Responsible Party):
University Clinical Centre, Gdansk

Brief 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).

Condition or disease Intervention/treatment Phase
Obesity Drug: Vitamin D 1200 IU Drug: Placebo Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Long-term Effects of Vitamin D Supplementation in Vitamin D Deficient Obese Children During Integrated Weight-loss Program - a Double Blind Placebo Controlled Study
Study Start Date : February 2016
Estimated Primary Completion Date : February 2018
Estimated Study Completion Date : February 2019

Resource links provided by the National Library of Medicine

Drug Information available for: Vitamin D

Arm Intervention/treatment
Experimental: Vitamin D 1200 IU
Supplementation with vitamin D (1200 IU) once a day for 26 weeks
Drug: Vitamin D 1200 IU
Vitamin D 1200 IU once a day for 26 weeks
Other Name: cholecalciferol

Placebo Comparator: Placebo
Placebo once a day for 26 weeks
Drug: Placebo
placebo once a day for 26 weeks




Primary Outcome Measures :
  1. Bone mineral density [ Time Frame: 12 months ]
    Increase in bone mineral density during weight-loss program and vitamin D supplementation


Secondary Outcome Measures :
  1. Blood level of vitamin D [ Time Frame: 12 months ]
    Changes in blood level of vitamin D after supplementation

  2. Arterial blood pressure [ Time Frame: 12 months ]
    Change in blood pressure afer weight-loss and vitamin D supplementation

  3. Lipid profile [ Time Frame: 12 months ]
    Change of lipid profile after weight-loss and vitamin D supplementation

  4. Oral Glucose Tolerance Test [ Time Frame: 12 months ]
    Change of biochemical parameters after weight-loss and vitamin D supplementation

  5. Chemerin [ Time Frame: 12 months ]
    Change in chemerin level

  6. BMI (kg/m2) [ Time Frame: 12 months ]
    Change of BMI during 12-months weight loss-program and supplementation of vitamin D

  7. Fat mass (kg) [ Time Frame: 12 months ]
    Change in fat free mass during 12-months weight-loss programme and supplementation of vitamin D



Information from the National Library of Medicine

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Ages Eligible for Study:   6 Years to 14 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02828228


Contacts
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Contact: Magdalena Słominska-Frączek, MD, 694844420 fraczek@gumed.edu.pl
Contact: Agnieszka Jankowska, MD, PhD 48606335246 ajankowska@gumed.edu.pl

Locations
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Poland
IUCCGdansk Recruiting
Gdansk, Pomorskie, Poland, 80-210
Contact: Agnieszka Szlagatys, MD, PhD    601622894    aga1@gumed.edu.pl   
Sponsors and Collaborators
University Clinical Centre, Gdansk
Nutricia Foundation
Investigators
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Principal Investigator: Agnieszka Szlagatys-Sidorkiewicz, MD, PhD University Clinical Centre, Gdansk

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: University Clinical Centre, Gdansk
ClinicalTrials.gov Identifier: NCT02828228     History of Changes
Other Study ID Numbers: 01/2016/UCK
First Posted: July 11, 2016    Key Record Dates
Last Update Posted: July 11, 2016
Last Verified: July 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Keywords provided by University Clinical Centre, Gdansk:
obesity
weight loss
vitamin D deficiency
body composition
Additional relevant MeSH terms:
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Weight Loss
Body Weight
Signs and Symptoms
Body Weight Changes
Vitamin D
Ergocalciferols
Vitamins
Micronutrients
Nutrients
Growth Substances
Physiological Effects of Drugs
Bone Density Conservation Agents
Calcium-Regulating Hormones and Agents