Vitamin D Intervention in Young Adults With Severe Childhood-onset Obesity

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02549326

Enrollment

Registered

2015-09-15

Start date

2012-11-30

Completion date

2013-05-31

Last updated

2015-09-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Obesity

Keywords

Vitamin D

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.

Interventions

DIETARY_SUPPLEMENTvitamin D

DIETARY_SUPPLEMENTPlacebo

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

15 Years to 25 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame	Description
change in S-25OHD	baseline, 6 and 12 weeks	change in total and free S-25OHD concentrations between obese and controls
baseline S-25OHD	baseline	differences in total and free S-25OHD between obese and controls

Secondary

Measure	Time frame	Description
baseline vitamin D-binding protein (DBP)	baseline	differences in DBP between obese and controls
correlation between S-25OHD and calcium, phosphate, parathyroid hormone (PTH) and osteocalcin	baseline, 6 and 12 weeks	correlation between S-25OHD (total and free) and calcium, phosphate, PTH and osteocalcin
change in vitamin D-binding protein (DBP)	baseline, 6 and 12 weeks	change in DBP concentrations between obese and controls

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026