The Efficacy of Different Vitamin D Supplementation Delivery Methods

Study Overview
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Brief Summary
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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

Detailed Description
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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

Official Title
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The Efficacy of Different Vitamin D Supplementation Delivery Methods on Serum 25(OH)D in Humans a Randomised Double-blind Placebo Trial

Conditions
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Vitamin D Deficiency

Intervention / Treatment
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* Dietary Supplement: vitamin D3
* Dietary Supplement: Pill
* Dietary Supplement: orange syrup
* Other: mineral oil
* Dietary Supplement: Penetrator


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: healthy, female Exclusion Criteria: any participant that was taking vitamin supplementation, had a skin condition that would prevent them from applying oil to their skin or were taking, or had been taking in the past 6-months, oestrogen based contraception

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Vitamin D3 pill<br>100 pills = 100,000IU + Dicalcium phosphate, microcrystalline cellulose, silicium dioxide, magnesium stearate | Dietary Supplement: vitamin D3<br>* 100,000IU<br>Dietary Supplement: Pill<br>* Dicalcium phosphate, microcrystalline cellulose, silicium dioxide, magnesium stearate<br>|
| Placebo Comparator: Pill placebo<br>100 pills = Dicalcium phosphate, microcrystalline cellulose, silicium dioxide, magnesium stearate | Dietary Supplement: Pill<br>* Dicalcium phosphate, microcrystalline cellulose, silicium dioxide, magnesium stearate<br>|
| Experimental: Vitamin D3 oral liquid<br>100 drops = 100,000IU in orange syrup | Dietary Supplement: vitamin D3<br>* 100,000IU<br>Dietary Supplement: orange syrup<br>* 100 drops orange syrup<br>|
| Placebo Comparator: Oral liquid placebo<br>100 drops orange syrup | Dietary Supplement: orange syrup<br>* 100 drops orange syrup<br>|
| Experimental: Skin oil + Vitamin D3 + penetrator<br>100,000IU + mineral oil+ Tangerine essential oil (10ml) | Dietary Supplement: vitamin D3<br>* 100,000IU<br>Other: mineral oil<br>* Paraffinum Liquidum,Isopropyl Palmitate,Parfum<br>Dietary Supplement: Penetrator<br>* Tangerine essential oil (10ml)<br>|
| Experimental: Skin oil + Vitamin D3<br>100,000IU + mineral oil | Dietary Supplement: vitamin D3<br>* 100,000IU<br>Other: mineral oil<br>* Paraffinum Liquidum,Isopropyl Palmitate,Parfum<br>|
| Placebo Comparator: Skin oil placebo<br>Skin application: 100ml of mineral oil coloured with food colourant to match active oil sample | Other: mineral oil<br>* Paraffinum Liquidum,Isopropyl Palmitate,Parfum<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| serum 25(OH)D | Changes in serum 25(OH)D levels | 4 weeks |