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

Obesity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02549326
• Other study ID #: 295/13/03/03/2012
• Status: Completed
• Phase: N/A
• First received: September 9, 2015
• Last updated: September 11, 2015
• Start date: November 2012
• Est. completion date: May 2013

Study information

• Verified date: September 2015
• Source: Helsinki University Central Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Finland: Ethics Committee
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 42
• Est. completion date: May 2013
• Est. primary completion date: May 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 15 Years to 25 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Obesity
• Pediatric Obesity

Intervention

Dietary Supplement:
• vitamin D

• Placebo

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Helsinki University Central Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	change in S-25OHD	change in total and free S-25OHD concentrations between obese and controls	baseline, 6 and 12 weeks	No
Primary	baseline S-25OHD	differences in total and free S-25OHD between obese and controls	baseline	No
Secondary	baseline vitamin D-binding protein (DBP)	differences in DBP between obese and controls	baseline	No
Secondary	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	baseline, 6 and 12 weeks	No
Secondary	change in vitamin D-binding protein (DBP)	change in DBP concentrations between obese and controls	baseline, 6 and 12 weeks	No