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| Name | Class |
|---|---|
| Royal National Orthopaedic Hospital NHS Trust | OTHER |
| University of Worcester | OTHER |
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To test the efficacy of different vitamin D delivery methods on serum 25(OH)D. Participants randomly assigned to one of seven groups - three placebo groups and 4 active supplement groups receiving 100,000IU vitamin D3
Various delivery methods of vitamin D supplementation are available to consumers but there have been no studies providing evidence of whether one delivery method is superior to others. The researchers wanted to compare the delivery of 100,000IU vitamin D3 by three methods on serum 25(OH)D levels. Two methods of oral supplementation (pill [prolonged release] and liquid [immediate release]), and delivery through the skin (with and without a penetrator enhancer. Placebo groups were pill, oral liquid and skin applied oil
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Vitamin D3 pill | Experimental | 100 pills = 100,000IU + Dicalcium phosphate, microcrystalline cellulose, silicium dioxide, magnesium stearate |
|
| Pill placebo | Placebo Comparator | 100 pills = Dicalcium phosphate, microcrystalline cellulose, silicium dioxide, magnesium stearate |
|
| Vitamin D3 oral liquid | Experimental | 100 drops = 100,000IU in orange syrup |
|
| Oral liquid placebo | Placebo Comparator | 100 drops orange syrup |
|
| Skin oil + Vitamin D3 + penetrator | Experimental | 100,000IU + mineral oil+ Tangerine essential oil (10ml) |
|
| Skin oil + Vitamin D3 |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| vitamin D3 | Dietary Supplement | 100,000IU |
|
| Measure | Description | Time Frame |
|---|---|---|
| serum 25(OH)D | Changes in serum 25(OH)D levels | 4 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Wolverhampton | Walsall | West Midlands | WS1 3BD | United Kingdom |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21118827 | Result | Ross AC, Manson JE, Abrams SA, Aloia JF, Brannon PM, Clinton SK, Durazo-Arvizu RA, Gallagher JC, Gallo RL, Jones G, Kovacs CS, Mayne ST, Rosen CJ, Shapses SA. The 2011 report on dietary reference intakes for calcium and vitamin D from the Institute of Medicine: what clinicians need to know. J Clin Endocrinol Metab. 2011 Jan;96(1):53-8. doi: 10.1210/jc.2010-2704. Epub 2010 Nov 29. | |
| 22426953 |
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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 |
| D008899 | Mineral Oil |
| ID | Term |
|---|---|
| D002782 | Cholestenes |
| D002776 | Cholestanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
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| Experimental |
100,000IU + mineral oil |
|
| Skin oil placebo | Placebo Comparator | Skin application: 100ml of mineral oil coloured with food colourant to match active oil sample |
|
| Pill | Dietary Supplement | Dicalcium phosphate, microcrystalline cellulose, silicium dioxide, magnesium stearate |
|
| orange syrup | Dietary Supplement | 100 drops orange syrup |
|
| mineral oil | Other | Paraffinum Liquidum,Isopropyl Palmitate,Parfum |
|
| Penetrator | Dietary Supplement | Tangerine essential oil (10ml) |
|
| Result |
| Stoll D, Dudler J, Lamy O, Hans D, Krieg MA, Aubry-Rozier B. Can one or two high doses of oral vitamin D3 correct insufficiency in a non-supplemented rheumatologic population? Osteoporos Int. 2013 Feb;24(2):495-500. doi: 10.1007/s00198-012-1962-5. Epub 2012 Mar 17. |
| 18991184 | Result | Leventis P, Kiely PD. The tolerability and biochemical effects of high-dose bolus vitamin D2 and D3 supplementation in patients with vitamin D insufficiency. Scand J Rheumatol. 2009 Mar-Apr;38(2):149-53. doi: 10.1080/03009740802419081. |
| 32703720 | Derived | Wyon MA, Wolman R, Martin C, Galloway S. The efficacy of different vitamin D supplementation delivery methods on serum 25(OH)D: A randomised double-blind placebo trial. Clin Nutr. 2021 Feb;40(2):388-393. doi: 10.1016/j.clnu.2020.05.040. Epub 2020 Jun 6. |
| D009750 |
| Nutritional and Metabolic Diseases |
| D011083 |
| Polycyclic Compounds |
| D013261 | Sterols |
| D014807 | Vitamin D |
| D012632 | Secosteroids |
| D008563 | Membrane Lipids |
| D008055 | Lipids |
| D010577 | Petrolatum |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |