Vitamin D Intervention in Young Adults With Severe Childhood-onset Obesity
1 other identifier
interventional
42
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable obesity
Started Nov 2012
Shorter than P25 for not_applicable obesity
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2013
CompletedFirst Submitted
Initial submission to the registry
September 9, 2015
CompletedFirst Posted
Study publicly available on registry
September 15, 2015
CompletedSeptember 15, 2015
September 1, 2015
6 months
September 9, 2015
September 11, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
change in S-25OHD
change in total and free S-25OHD concentrations between obese and controls
baseline, 6 and 12 weeks
baseline S-25OHD
differences in total and free S-25OHD between obese and controls
baseline
Secondary Outcomes (3)
baseline vitamin D-binding protein (DBP)
baseline
correlation between S-25OHD and calcium, phosphate, parathyroid hormone (PTH) and osteocalcin
baseline, 6 and 12 weeks
change in vitamin D-binding protein (DBP)
baseline, 6 and 12 weeks
Study Arms (4)
Obese, placebo
PLACEBO COMPARATORPlacebo daily for 12 weeks
Obese, vitamin D
ACTIVE COMPARATORVitamin D3 50 µg / daily for 12 weeks
Control, placebo
PLACEBO COMPARATORPlacebo daily for 12 weeks
Control, vitamin D
ACTIVE COMPARATORVitamin D3 50 µg / daily for 12 weeks
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- endocrine or genetic disorders underlying obesity (e.g. Prader Willi syndrome, pseudohypoparathyroidism, hypothyroidism, hypercortisolism, diabetes
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Helena Valta, MD PhD
Helsinki University Central Hospital
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- MD
Study Record Dates
First Submitted
September 9, 2015
First Posted
September 15, 2015
Study Start
November 1, 2012
Primary Completion
May 1, 2013
Study Completion
May 1, 2013
Last Updated
September 15, 2015
Record last verified: 2015-09