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
- Analyze the influence of vitamin D supplementation in obese children during weight-loss program on BMI, body composition and bone mineral density.
- 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.
- Analyze the prevalence of vitamin D deficiency among obese children.
- 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
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||200 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|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|
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
placebo once a day for 26 weeks
- Bone mineral density [ Time Frame: 12 months ]Increase in bone mineral density during weight-loss program and vitamin D supplementation
- Blood level of vitamin D [ Time Frame: 12 months ]Changes in blood level of vitamin D after supplementation
- Arterial blood pressure [ Time Frame: 12 months ]Change in blood pressure afer weight-loss and vitamin D supplementation
- Lipid profile [ Time Frame: 12 months ]Change of lipid profile after weight-loss and vitamin D supplementation
- Oral Glucose Tolerance Test [ Time Frame: 12 months ]Change of biochemical parameters after weight-loss and vitamin D supplementation
- Chemerin [ Time Frame: 12 months ]Change in chemerin level
- BMI (kg/m2) [ Time Frame: 12 months ]Change of BMI during 12-months weight loss-program and supplementation of vitamin D
- Fat mass (kg) [ Time Frame: 12 months ]Change in fat free mass during 12-months weight-loss programme and supplementation of vitamin D
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
|Contact: Magdalena Słominska-Frączek, MD,||firstname.lastname@example.org|
|Contact: Agnieszka Jankowska, MD, PhDemail@example.com|
|Gdansk, Pomorskie, Poland, 80-210|
|Contact: Agnieszka Szlagatys, MD, PhD 601622894 firstname.lastname@example.org|
|Principal Investigator:||Agnieszka Szlagatys-Sidorkiewicz, MD, PhD||University Clinical Centre, Gdansk|