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

Helsinki University Central Hospital42 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

DOUBLE

Enrollment

Conditions

Obesity

Interventions

vitamin DDIETARY_SUPPLEMENT

PlaceboDIETARY_SUPPLEMENT

Eligibility

Sex: ALLMin age: 15 YearsMax age: 25 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

change in S-25OHD

change in total and free S-25OHD concentrations between obese and controls

Time frame: baseline, 6 and 12 weeks

baseline S-25OHD

differences in total and free S-25OHD between obese and controls

Time frame: baseline

Secondary Outcomes

baseline vitamin D-binding protein (DBP)

differences in DBP between obese and controls

Time frame: 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

Time frame: baseline, 6 and 12 weeks

change in vitamin D-binding protein (DBP)

change in DBP concentrations between obese and controls

Time frame: baseline, 6 and 12 weeks

Data from ClinicalTrials.gov

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