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This winter-based placebo-controlled, single-dose vitamin D randomized controlled trial (RCT) aims to examine the impact of various levels of habitual calcium intake on dietary vitamin D requirements in older adults stratified by calcium intake. This will provide new data on the impact of different levels of calcium intake, ranging from low/moderate to high, on winter serum 25(OH)D levels, and their utilization and catabolism in adults.
The aim of this study is to perform a randomised controlled vitamin D3 intervention study in apparently healthy, free-living adults (aged 50+ y) to investigate whether different levels of habitual calcium intake, ranging from low-moderate to high, influence serum 25(OH)D concentrations and indices of vitamin D activation and catabolism during winter, when vitamin D intake is adequate versus inadequate.
This research will provide new data and scientific understanding in relation to the impact of different levels of dietary calcium intake on vitamin D requirements in the older adult population. As such, this new data will inform dietary reference values for vitamin D.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo in high calcium group | Placebo Comparator | Placebo + habitual dietary calcium intake (>1000 mg/d) |
|
| Vitamin D3 in low/moderate calcium group | Active Comparator | Vitamin D3 (20 microgram/day) + habitual calcium intake <700 mg/d |
|
| Placebo in low/moderate calcium group | Placebo Comparator | Placebo + habitual calcium intake <700 mg/d |
|
| Vitamin D3 in high calcium group | Active Comparator | Vitamin D3 (20 microgram/day) + habitual calcium intake (>1000 mg/d) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Vitamin D3 (20 micrograms/day) | Dietary Supplement | Vitamin D3 (20 micrograms/day) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Response of serum 25(OH)D concentration over winter in subjects stratified by calcium intake | 0, 8, 15 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Serum albumin-adjusted calcium | 0, 8, 15 weeks | |
| serum parathyroid hormone | 0, 8, 15 weeks | |
| Serum 24,25(OH)2D |
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Inclusion Criteria:
Consenting white men and women aged ≥ 50 y
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Kevin D Cashman, BSc. PhD | University College Cork | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Human Dietary Studies Facility, School of Food and Nutritional Sciences, University College Cork, Cork, Ireland | Cork | Ireland |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24828024 | Derived | Cashman KD, Kinsella M, Walton J, Flynn A, Hayes A, Lucey AJ, Seamans KM, Kiely M. The 3 epimer of 25-hydroxycholecalciferol is present in the circulation of the majority of adults in a nationally representative sample and has endogenous origins. J Nutr. 2014 Jul;144(7):1050-7. doi: 10.3945/jn.114.192419. Epub 2014 May 14. | |
| 24695896 |
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| ID | Term |
|---|---|
| D014808 | Vitamin D Deficiency |
| ID | Term |
|---|---|
| D001361 | Avitaminosis |
| D003677 | Deficiency Diseases |
| D044342 | Malnutrition |
| D009748 | Nutrition Disorders |
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| ID | Term |
|---|---|
| D002762 | Cholecalciferol |
| ID | Term |
|---|---|
| D002782 | Cholestenes |
| D002776 | Cholestanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
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| Placebo | Dietary Supplement | Placebo (0 micrograms vitamin D3/day) |
|
| 0 and 15 weeks |
| Serum 1,25(OH)2D | 0 and 15 weeks |
| Serum free 25(OH)D | 0 and 15 weeks |
| Serum vitamin D binding protein | 0 and 15 weeks |
| Cashman KD, Hayes A, O'Donovan SM, Zhang JY, Kinsella M, Galvin K, Kiely M, Seamans KM. Dietary calcium does not interact with vitamin D(3) in terms of determining the response and catabolism of serum 25-hydroxyvitamin D during winter in older adults. Am J Clin Nutr. 2014 Jun;99(6):1414-23. doi: 10.3945/ajcn.113.080358. Epub 2014 Apr 2. |
| D009750 |
| Nutritional and Metabolic Diseases |
| D011083 |
| Polycyclic Compounds |
| D013261 | Sterols |
| D014807 | Vitamin D |
| D012632 | Secosteroids |
| D008563 | Membrane Lipids |
| D008055 | Lipids |