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Completed

NCT Number: NCT02549326

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

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.

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Key information

Conditions

Obesity Body Weight Nutrition Disorders Nutritional and Metabolic Diseases Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

15 year–25 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Vitamin D

Dietary Supplement

Other names: cholecalciferol

Placebo

Dietary Supplement

Primary outcomes

  1. change in S-25OHD

    Time frame: baseline, 6 and 12 weeks

    change in total and free S-25OHD concentrations between obese and controls

  2. baseline S-25OHD

    Time frame: baseline

    differences in total and free S-25OHD between obese and controls

Secondary outcomes

  1. baseline vitamin D-binding protein (DBP)

    Time frame: baseline

    differences in DBP between obese and controls

  2. 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

  3. change in vitamin D-binding protein (DBP)

    Time frame: baseline, 6 and 12 weeks

    change in DBP concentrations between obese and controls

Sponsors and collaborators

Lead sponsor

Helsinki University Central Hospital

Other

Registry information

Important dates

Study start
2012
Primary completion
2013
Study completion
2013
First posted
Sep 15, 2015
Registry last updated
Sep 15, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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