RCT buccal spray for poor gut - Oct 2015
Radomized two way cross over study for comparison of absorption of vitamin D3 buccal spray and soft gelatin capsule formulation in healthy subjects and in patients with intestinal malabsorption
Nutrition Journal 2015, 14:114 doi:10.1186/s12937-015-0105-1
MC Satia1 milansatia at ethicare-cro.com, AG Mukim2, KD Tibrewala3 and MS Bhavsar4
1 Ethicare Clinical Trial Services, Ahmedabad, India
2 Mukim Medical And Nursing Homes, Ahmedabad, India
3 Tibrewala’s Clinic, Ahmedabad, India
4 Bhavsar’s Clinic, Ahmedabad, India
1000 IU given daily for 30 days to: healthy gut, poor gut
_| Buccal | 10 ng |
| Oral | 5 ng |
Previous studies:
1000 IU ==> 5 ng ( has been 1000 IU ==> 10 ng)
Vitamin D as a pill: More response from powder than oil
Apparently: Buccal > Sublingual > Oral
Apparently:Topical > Oral
Apparently speed of response: Buccal > sublingual > oral
Amazon sells 100 Vitamin D sprays as of Dec 2018
Possible alternatives to spray:
Drops, water-soluable powder (Bio-Tech)
Which may provide as much response and as fast response as spray at much lower cost
Strangely this study failed to mention
The type of gel cap liquid - perhaps oil
When the caps were taken - far better if take Vitamin D orally with the largest meal of the day
What the caps were taken with - gel caps much better if taken with a fatty meal
See also Vitamin D Life
- Sublingual vitamin D
- Sublingual vitamin D gave similar response as oral for most, and better for some – RCT Sept 2019
- Spray vitamin D inside cheek in case of emergency - Nov 2012
Time to reach half of the response to oral vitamin D is about 32 hours
Vs Time for spray on the cheek is about 4 hours, perhaps 8X faster! - Topical vitamin D might be more bio-available than oral – Oct 2015
- Alternatives if not swallow pills or not absorb vitamin D
- Topical vitamin D raised blood level to 38 ng (used Aloe Vera gel) – RCT March 2014
- Pill taking is not a problem with vitamin D
- Vitamin D bioavailability: State of the art – Oct 2014
- How you might double your response to vitamin D
- Oil-based Vitamin D3 has the worst bioavailability – April 2014
- Getting Vitamin D into your body
- 200 IU needed to increase vitamin D levels by 1 ng (not 100 IU) – summary of 25 studies – Feb 2014 which has the following chart
This was a crossover study
Download the PDF from Vitamin D Life
Background
Vitamin D deficiency has been proposed to contribute to the development of malabsorption diseases. Despite this, the vitamin D status of these patients is often neglected. The objective of the present work was to compare the absorption of vitamin D 3 through the oral route by comparing a 1000 IU soft gelatin capsule and a 500 IU buccal spray (delivering 1000 IU in two spray shots) in healthy subjects and in patients with malabsorption disease.
Methods
An open label, randomized, two-periods, two-way cross over study was conducted, first in healthy subjects (n = 20) and then in patients with malabsorption syndrome (n = 20). The study participants were equally divided and received either of the treatments (buccal spray, n = 7; soft gelatin capsule, n = 7; control, n = 6) in Period I for 30 days. After washout of another 30 days, the treatments were changed in crossover fashion in Period II. Fasting blood samples were collected to measure baseline 25-hydroxyvitamin D [25(OH)D] levels in all participants at day 0 (Screening visit), day 30 (completion of period I), day 60 (end of wash out and initiation of period II) and day 90 (completion of period II). Safety was evaluated by hematology and biochemistry analyses. Statistical analyses was performed using differences of mean and percentage change from baseline of 25(OH)D levels between two formulation by two tailed Paired t-test with 95 % confidence interval.
Results
In healthy subjects, the mean increase in serum 25(OH)D concentration was 4.06 (95 % CI 3.41, 4.71) ng/ml in soft gelatin capsule group and 8.0 (95 % CI 6.86, 9.13) ng/ml in buccal spray group after 30 days treatment (p < 0.0001). In patients with malabsorption disease, the mean increase in serum 25(OH)D concentration was 3.96 (95 % CI 2.37, 5.56) ng/ml in soft gelatin capsule group and 10.46 (95 % CI 6.89, 14.03) ng/ml in buccal spray group (p < 0.0001).
Conclusion
It can be concluded from the results that the buccal spray produced a significantly higher mean serum 25(OH)D concentration as compared to the soft gelatin capsule, in both healthy subjects as well as in patients with malabsorption syndrome over a period of 30 days administration in a two way cross over study. Treatments were well tolerated by both subject groups
New buccal spray review proposed Dec 2018
Comparative effectiveness of vitamin D supplementation via buccal spray versus oral supplements on serum 25-hydroxyvitamin D concentrations in humans: a systematic review protocol.
JBI Database System Rev Implement Rep. 2018 Dec 3. doi: 10.11124/JBISRIR-2017-003907Pritchard L1,2, Lewis S3, Hickson M2.
| 2295 visitors, last modified 17 Oct, 2019, |
| ID | Name | Comment | Uploaded | Size | Downloads | |
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| 6124 | Buccal F1.jpg | admin 31 Oct, 2015 08:43 | 64.48 Kb | 1825 | ||
| 6123 | Buccal F2.jpg | admin 31 Oct, 2015 08:20 | 26.11 Kb | 1843 | ||
| 6122 | Buccal capsule.pdf | PDF 2015 | admin 31 Oct, 2015 08:20 | 882.63 Kb | 698 |