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

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ClinicalTrials.gov Identifier: NCT02549326
Recruitment Status : Completed
First Posted : September 15, 2015
Last Update Posted : September 15, 2015
Sponsor:
Information provided by (Responsible Party):
Elisa Holmlund-Suila, Helsinki University Central Hospital

Brief 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.


Condition or disease Intervention/treatment Phase
Obesity Dietary Supplement: vitamin D Dietary Supplement: Placebo Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 42 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Prevention
Official Title: Vitamin D Intervention in Young Adults With Severe Childhood-onset Obesity
Study Start Date : November 2012
Actual Primary Completion Date : May 2013
Actual Study Completion Date : May 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Vitamin D

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 Name: 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 Name: cholecalciferol




Primary Outcome Measures :
  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 Outcome Measures :
  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



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Ages Eligible for Study:   15 Years to 25 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02549326


Sponsors and Collaborators
Helsinki University Central Hospital
Investigators
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Study Director: Helena Valta, MD PhD Helsinki University Central Hospital
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Responsible Party: Elisa Holmlund-Suila, MD, Helsinki University Central Hospital
ClinicalTrials.gov Identifier: NCT02549326    
Other Study ID Numbers: 295/13/03/03/2012
First Posted: September 15, 2015    Key Record Dates
Last Update Posted: September 15, 2015
Last Verified: September 2015
Keywords provided by Elisa Holmlund-Suila, Helsinki University Central Hospital:
Vitamin D
Additional relevant MeSH terms:
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Obesity
Pediatric Obesity
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Vitamin D
Cholecalciferol
Vitamins
Micronutrients
Nutrients
Growth Substances
Physiological Effects of Drugs
Bone Density Conservation Agents
Calcium-Regulating Hormones and Agents