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

NCT ID: NCT02549326

Last Updated: 2015-09-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

42 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-11-30

Study Completion Date

2013-05-31

Brief Summary

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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

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Conditions

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Obesity

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Obese, placebo

Placebo daily for 12 weeks

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DIETARY_SUPPLEMENT

Obese, vitamin D

Vitamin D3 50 µg / daily for 12 weeks

Group Type ACTIVE_COMPARATOR

vitamin D

Intervention Type DIETARY_SUPPLEMENT

Control, placebo

Placebo daily for 12 weeks

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DIETARY_SUPPLEMENT

Control, vitamin D

Vitamin D3 50 µg / daily for 12 weeks

Group Type ACTIVE_COMPARATOR

vitamin D

Intervention Type DIETARY_SUPPLEMENT

Interventions

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vitamin D

Intervention Type DIETARY_SUPPLEMENT

Placebo

Intervention Type DIETARY_SUPPLEMENT

Other Intervention Names

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cholecalciferol

Eligibility Criteria

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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
Minimum Eligible Age

15 Years

Maximum Eligible Age

25 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Helsinki University Central Hospital

OTHER

Sponsor Role lead

Responsible Party

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Elisa Holmlund-Suila

MD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Helena Valta, MD PhD

Role: STUDY_DIRECTOR

Helsinki University Central Hospital

Other Identifiers

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295/13/03/03/2012

Identifier Type: -

Identifier Source: org_study_id

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