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

Not Applicable

Completed

• Conditions: Obesity
• Interventions: Dietary Supplement: vitamin D; Dietary Supplement: Placebo

• Registration Number: NCT02549326
• Lead Sponsor: Helsinki University Central Hospital

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-11
• Primary Completion: 2013-05
• Study Completion: 2013-05
• Status Verified: 2015-09
• Study First Submitted: 2015-09-09
• Study First Submitted QC: 2015-09-11
• Last Update Submitted: 2015-09-11
• Study First Posted: 2015-09-15
• Last Update Posted: 2015-09-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 42

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control, vitamin D	vitamin D	Vitamin D3 50 µg / daily for 12 weeks
Obese, placebo	Placebo	Placebo daily for 12 weeks
Obese, vitamin D	vitamin D	Vitamin D3 50 µg / daily for 12 weeks
Control, placebo	Placebo	Placebo daily for 12 weeks

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
change in vitamin D-binding protein (DBP)	baseline, 6 and 12 weeks	change in DBP concentrations between obese and controls
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