ObesityNCT02549326
Vitamin D Intervention in Young Adults With Severe Childhood-onset Obesity
A study testing vitamin D in people with Obesity, run by Helsinki University Central Hospital.
Trial 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. Read more about this study
- Who is it for?
- Ages 15 to 25 yearsHealthy volunteers can take part
- Conditions the study is for
- Obesity
- What is being tested?
- vitamin D
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 42 participants
- Where
- No sites listed yet
- Study dates
- Nov 2012to May 2013
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 15 to 25 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- 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
Who cannot join
- endocrine or genetic disorders underlying obesity (e.g. Prader Willi syndrome, pseudohypoparathyroidism, hypothyroidism, hypercortisolism, diabetes
About this study
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.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
vitamin DDietary supplement
Also called cholecalciferol
PlaceboDietary supplement
| Study group | Role | What they receive |
|---|---|---|
| Obese, placebo | Placebo comparator | Placebo daily for 12 weeks Receives: Dietary Supplement: Placebo |
| Obese, vitamin D | Active comparator | Vitamin D3 50 µg / daily for 12 weeks Receives: Dietary Supplement: vitamin D |
| Control, placebo | Placebo comparator | Placebo daily for 12 weeks Receives: Dietary Supplement: Placebo |
| Control, vitamin D | Active comparator | Vitamin D3 50 µg / daily for 12 weeks Receives: Dietary Supplement: vitamin D |
What is being measured
The primary outcome is the main question the study is designed to answer.
change in S-25OHD
change in total and free S-25OHD concentrations between obese and controls
Measured: baseline, 6 and 12 weeks
baseline S-25OHD
differences in total and free S-25OHD between obese and controls
Measured: baseline
Secondary outcomes (3)
baseline vitamin D-binding protein (DBP)
differences in DBP between obese and controls
Measured: baseline
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
Measured: baseline, 6 and 12 weeks
change in vitamin D-binding protein (DBP)
change in DBP concentrations between obese and controls
Measured: baseline, 6 and 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Sep 2015 (estimated)
- Study startNov 2012
- Primary completionMay 2013
- Study completionMay 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies of the same condition, open and under way.
- More trials run by Helsinki University Central HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- Helsinki University Central Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Elisa Holmlund-Suila, Helsinki University Central Hospital
- Investigators
- Helena Valta, MD PhD, Study director, Helsinki University Central Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02549326
- Sponsor's protocol ID
- 295/13/03/03/2012
- Status last verified
- Sep 2015
- First submitted
- 9 Sep 2015
- Last updated
- 15 Sep 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Sep 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Vitamin D Intervention in Young Adults With Severe Childhood-onset Obesity
- ClinicalTrials.gov ID
- NCT02549326
- Acronym / sponsor ID
- 295/13/03/03/2012
- Conditions
- Obesity
- Keywords
- Vitamin D
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- Helsinki University Central HospitalUniversity, hospital or other
- Study start
- Nov 2012
- Primary completion
- May 2013 (actual)
- Study completion
- May 2013 (actual)
- First posted
- 15 Sep 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Obese, placebo | Placebo comparator | Dietary Supplement: PlaceboPlacebo daily for 12 weeks |
| Obese, vitamin D | Active comparator | Dietary Supplement: vitamin DVitamin D3 50 µg / daily for 12 weeks |
| Control, placebo | Placebo comparator | Dietary Supplement: PlaceboPlacebo daily for 12 weeks |
| Control, vitamin D | Active comparator | Dietary Supplement: vitamin DVitamin D3 50 µg / daily for 12 weeks |
Who may qualify
- Ages
- 15 to 25 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (1 listed)
- endocrine or genetic disorders underlying obesity (e.g. Prader Willi syndrome, pseudohypoparathyroidism, hypothyroidism, hypercortisolism, diabetes
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| vitamin DAlso: cholecalciferol | Dietary supplement | Control, vitamin D, Obese, vitamin D |
| Placebo | Dietary supplement | Control, placebo, Obese, placebo |
Primary outcome
change in S-25OHD
Time frame: baseline, 6 and 12 weeks
change in total and free S-25OHD concentrations between obese and controls
baseline S-25OHD
Time frame: baseline
differences in total and free S-25OHD between obese and controls
3 secondary outcomes
baseline vitamin D-binding protein (DBP)
Time frame: baseline
correlation between S-25OHD and calcium, phosphate, parathyroid hormone (PTH) and osteocalcin
Time frame: baseline, 6 and 12 weeks
change in vitamin D-binding protein (DBP)
Time frame: baseline, 6 and 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Sep 2015.
Related trials for Obesity
RecruitingObservational study
Endoscopic Sleeve Gastroplasty (ESG) Prospective Trial for Obesity (EGO-Trial)
Obesity
Active, not recruitingPhase 4
Effects of Sequential Therapy With Mexidol® (Intravenous) and Mexidol® FORTE 250 (Oral) on Functional Brain Activity Assessed by Functional Magnetic Resonance Imaging and Biochemical Parameters in Patients With Chronic Cerebral Ischemia: A Comparison of Patients With and Without Metabolic Disorders
Metabolic Abnormalities, Obesity & Overweight
Recruiting
Exercise Training and Vitamin D Metabolism
Obesity & Overweight, Vitamin D
Recruiting
Metabolic Health, Bones and Nuts During Weight Loss in Adults
Weight Loss, Bone Density
Active, not recruiting
Effect of Probiotics on Insulin Sensitivity in Overweight and Obese Pregnancy
Obesity & Overweight, Gestational Diabetes Mellitus (GDM)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Helena Valta, MD PhD study director
Helsinki University Central Hospital
Questions about this trial
What is this clinical trial studying?
A study testing vitamin D in people with Obesity, run by Helsinki University Central Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Sep 2015. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
change in S-25OHD (time frame: baseline, 6 and 12 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Sep 2015.