The Efficacy of Different Vitamin D Supplementation Delivery Methods

University of Wolverhampton

Status: Completed

Conditions: Vitamin D Deficiency

Treatments: Dietary Supplement: vitamin D3; Dietary Supplement: orange syrup; Dietary Supplement: Pill; Dietary Supplement: Penetrator; Other: mineral oil

Study type: Interventional

Funder types: Other

Identifiers

NCT03463642

UoW116976

Details and patient eligibility

About

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

Full description

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

Enrollment: 62 patients

Sex: Female

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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62 participants in 7 patient groups, including a placebo group

Vitamin D3 pill

Experimental group

Description:

100 pills = 100,000IU + Dicalcium phosphate, microcrystalline cellulose, silicium dioxide, magnesium stearate

Treatment:

Dietary Supplement: vitamin D3

Dietary Supplement: Pill

Pill placebo

Placebo Comparator group

Description:

100 pills = Dicalcium phosphate, microcrystalline cellulose, silicium dioxide, magnesium stearate

Treatment:

Dietary Supplement: Pill

Vitamin D3 oral liquid

Experimental group

Description:

100 drops = 100,000IU in orange syrup

Treatment:

Dietary Supplement: vitamin D3

Dietary Supplement: orange syrup

Oral liquid placebo

Placebo Comparator group

Description:

100 drops orange syrup

Treatment:

Dietary Supplement: orange syrup

Skin oil + Vitamin D3 + penetrator

Experimental group

Description:

100,000IU + mineral oil+ Tangerine essential oil (10ml)

Treatment:

Dietary Supplement: vitamin D3

Other: mineral oil

Dietary Supplement: Penetrator

Skin oil + Vitamin D3

Experimental group

Description:

100,000IU + mineral oil

Treatment:

Dietary Supplement: vitamin D3

Other: mineral oil

Skin oil placebo

Placebo Comparator group

Description:

Skin application: 100ml of mineral oil coloured with food colourant to match active oil sample

Treatment:

Other: mineral oil