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

September 11, 2015 updated by: Elisa Holmlund-Suila, Helsinki University Central Hospital

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

42

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

15 years to 25 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Obese, placebo
Placebo daily for 12 weeks
Dietary supplement: Placebo
Active Comparator: Obese, vitamin D
Vitamin D3 50 µg / daily for 12 weeks
Dietary supplement: vitamin D
Other Names:
  • cholecalciferol
Placebo Comparator: Control, placebo
Placebo daily for 12 weeks
Dietary supplement: Placebo
Active Comparator: Control, vitamin D
Vitamin D3 50 µg / daily for 12 weeks
Dietary supplement: vitamin D
Other Names:
  • cholecalciferol

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
change in S-25OHD
Time Frame: baseline, 6 and 12 weeks
change in total and free S-25OHD concentrations between obese and controls
baseline, 6 and 12 weeks
baseline S-25OHD
Time Frame: baseline
differences in total and free S-25OHD between obese and controls
baseline

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
baseline vitamin D-binding protein (DBP)
Time Frame: baseline
differences in DBP between obese and controls
baseline
correlation between S-25OHD and calcium, phosphate, parathyroid hormone (PTH) and osteocalcin
Time Frame: baseline, 6 and 12 weeks
correlation between S-25OHD (total and free) and calcium, phosphate, PTH and osteocalcin
baseline, 6 and 12 weeks
change in vitamin D-binding protein (DBP)
Time Frame: baseline, 6 and 12 weeks
change in DBP concentrations between obese and controls
baseline, 6 and 12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Helsinki University Central Hospital

Investigators

  • Study Director: Helena Valta, MD PhD, Helsinki University Central Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2012

Primary Completion (Actual)

May 1, 2013

Study Completion (Actual)

May 1, 2013

Study Registration Dates

First Submitted

September 9, 2015

First Submitted That Met QC Criteria

September 11, 2015

First Posted (Estimate)

September 15, 2015

Study Record Updates

Last Update Posted (Estimate)

September 15, 2015

Last Update Submitted That Met QC Criteria

September 11, 2015

Last Verified

September 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 295/13/03/03/2012

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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