Back to resultsVitamin D Intervention in Young Adults With Severe Childhood-onset Obesity
Primary Purpose
Obesity
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
vitamin D
Placebo
Sponsored by
About this trial
This is an interventional prevention trial for Obesity focused on measuring Vitamin D
Eligibility Criteria
Inclusion Criteria:
- weight-for-height ratio exceeding 60% before the age of 7 years, according to Finnish growth standards and persistence of severe obesity for at least three years in childhood
- referral to the Children's Hospital, Helsinki University Hospital due to severe obesity
- at the age of 7 years lived in the greater Helsinki area
Exclusion Criteria:
- endocrine or genetic disorders underlying obesity (e.g. Prader Willi syndrome, pseudohypoparathyroidism, hypothyroidism, hypercortisolism, diabetes
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Placebo Comparator
Active Comparator
Placebo Comparator
Active Comparator
Arm Label
Obese, placebo
Obese, vitamin D
Control, placebo
Control, vitamin D
Arm Description
Placebo daily for 12 weeks
Vitamin D3 50 µg / daily for 12 weeks
Placebo daily for 12 weeks
Vitamin D3 50 µg / daily for 12 weeks
Outcomes
Primary Outcome Measures
change in S-25OHD
change in total and free S-25OHD concentrations between obese and controls
baseline S-25OHD
differences in total and free S-25OHD between obese and controls
Secondary Outcome Measures
baseline vitamin D-binding protein (DBP)
differences in DBP between obese and controls
correlation between S-25OHD and calcium, phosphate, parathyroid hormone (PTH) and osteocalcin
correlation between S-25OHD (total and free) and calcium, phosphate, PTH and osteocalcin
change in vitamin D-binding protein (DBP)
change in DBP concentrations between obese and controls
Full Information
NCT ID
NCT02549326
First Posted
September 9, 2015
Last Updated
September 11, 2015
Sponsor
Helsinki University Central Hospital
1. Study Identification
Unique Protocol Identification Number
NCT02549326
Brief Title
Vitamin D Intervention in Young Adults With Severe Childhood-onset Obesity
Official Title
Vitamin D Intervention in Young Adults With Severe Childhood-onset Obesity
Study Type
Interventional
2. Study Status
Record Verification Date
September 2015
Overall Recruitment Status
Completed
Study Start Date
November 2012 (undefined)
Primary Completion Date
May 2013 (Actual)
Study Completion Date
May 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Helsinki University Central Hospital
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
Obesity is associated with lower total serum 25-hydroxycholecalciferol (S-25OHD) concentration. However, the impact of obesity on free S-25OHD is inadequately studied. A direct assay for free 25OHD was introduced recently.
The aim of the study was to evaluate differences in vitamin D metabolism between young adults with severe childhood-onset obesity and normal-weight controls. Half of the obese subjects and controls will receive placebo and the other half will receive vitamin D3 50 µg daily for 12 weeks.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity
Keywords
Vitamin D
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
42 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Obese, placebo
Arm Type
Placebo Comparator
Arm Description
Placebo daily for 12 weeks
Arm Title
Obese, vitamin D
Arm Type
Active Comparator
Arm Description
Vitamin D3 50 µg / daily for 12 weeks
Arm Title
Control, placebo
Arm Type
Placebo Comparator
Arm Description
Placebo daily for 12 weeks
Arm Title
Control, vitamin D
Arm Type
Active Comparator
Arm Description
Vitamin D3 50 µg / daily for 12 weeks
Intervention Type
Dietary Supplement
Intervention Name(s)
vitamin D
Other Intervention Name(s)
cholecalciferol
Intervention Type
Dietary Supplement
Intervention Name(s)
Placebo
Primary Outcome Measure Information:
Title
change in S-25OHD
Description
change in total and free S-25OHD concentrations between obese and controls
Time Frame
baseline, 6 and 12 weeks
Title
baseline S-25OHD
Description
differences in total and free S-25OHD between obese and controls
Time Frame
baseline
Secondary Outcome Measure Information:
Title
baseline vitamin D-binding protein (DBP)
Description
differences in DBP between obese and controls
Time Frame
baseline
Title
correlation between S-25OHD and calcium, phosphate, parathyroid hormone (PTH) and osteocalcin
Description
correlation between S-25OHD (total and free) and calcium, phosphate, PTH and osteocalcin
Time Frame
baseline, 6 and 12 weeks
Title
change in vitamin D-binding protein (DBP)
Description
change in DBP concentrations between obese and controls
Time Frame
baseline, 6 and 12 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
15 Years
Maximum Age & Unit of Time
25 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
weight-for-height ratio exceeding 60% before the age of 7 years, according to Finnish growth standards and persistence of severe obesity for at least three years in childhood
referral to the Children's Hospital, Helsinki University Hospital due to severe obesity
at the age of 7 years lived in the greater Helsinki area
Exclusion Criteria:
endocrine or genetic disorders underlying obesity (e.g. Prader Willi syndrome, pseudohypoparathyroidism, hypothyroidism, hypercortisolism, diabetes
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Helena Valta, MD PhD
Organizational Affiliation
Helsinki University Central Hospital
Official's Role
Study Director
12. IPD Sharing Statement
Learn more about this trial
Vitamin D Intervention in Young Adults With Severe Childhood-onset Obesity
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