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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Obese, placebo | Placebo Comparator | Placebo daily for 12 weeks |
|
| Obese, vitamin D | Active Comparator | Vitamin D3 50 µg / daily for 12 weeks |
|
| Control, placebo | Placebo Comparator | Placebo daily for 12 weeks |
|
| Control, vitamin D | Active Comparator | Vitamin D3 50 µg / daily for 12 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| vitamin D | Dietary Supplement |
|
| |
| Measure | Description | Time Frame |
|---|---|---|
| change in S-25OHD | change in total and free S-25OHD concentrations between obese and controls | baseline, 6 and 12 weeks |
| baseline S-25OHD | differences in total and free S-25OHD between obese and controls | baseline |
| Measure | Description | Time Frame |
|---|---|---|
| baseline vitamin D-binding protein (DBP) | differences in DBP between obese and controls | baseline |
| correlation between S-25OHD and calcium, phosphate, parathyroid hormone (PTH) and osteocalcin |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Helena Valta, MD PhD | Helsinki University Central Hospital | Study Director |
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| ID | Term |
|---|---|
| D009765 | Obesity |
| ID | Term |
|---|---|
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| D014807 | Vitamin D |
| D002762 | Cholecalciferol |
| ID | Term |
|---|---|
| D012632 | Secosteroids |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
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| Placebo |
| Dietary Supplement |
|
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) | change in DBP concentrations between obese and controls | baseline, 6 and 12 weeks |
| D001835 |
| Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D002782 |
| Cholestenes |
| D002776 | Cholestanes |
| D013261 | Sterols |
| D008563 | Membrane Lipids |
| D008055 | Lipids |