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

Helsinki University Central Hospital (HUCH)

Status: Completed

Conditions: Obesity

Treatments: Dietary Supplement: vitamin D; Dietary Supplement: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT02549326

295/13/03/03/2012

Details and patient eligibility

About

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.

Enrollment: 42 patients

Sex: All

Ages: 15 to 25 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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42 participants in 4 patient groups, including a placebo group

Obese, placebo

Placebo Comparator group

Description:

Placebo daily for 12 weeks

Treatment:

Dietary Supplement: Placebo

Obese, vitamin D

Active Comparator group

Description:

Vitamin D3 50 µg / daily for 12 weeks

Treatment:

Dietary Supplement: vitamin D

Control, placebo

Placebo Comparator group

Description:

Placebo daily for 12 weeks

Treatment:

Dietary Supplement: Placebo

Control, vitamin D

Active Comparator group

Description:

Vitamin D3 50 µg / daily for 12 weeks

Treatment:

Dietary Supplement: vitamin D