Trial reportNutrition journal2015
A randomized 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.
Trial report in Nutrition journal, 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 18 papers, 1 of them a synthesis that pooled it.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
18 citing papers in PubMed, 1 synthesis or guideline pooled it, 33 citations in OpenAlex.
- Efficacy of Vitamin DNutrients · 2020Pooled it
- Investigating the Efficiency of Vitamin D Administration with Buccal Spray in the Treatment of Vitamin D Deficiency in Children and AdolescentsJournal of clinical research in pediatric endocrinology · 2021Trial
- Efficiency of Vitamin D Supplementation in Healthy Adults is Associated with Body Mass Index and Baseline Serum 25-Hydroxyvitamin D Level.Nutrients · 2020Trial
- Rate of change of circulating 25-hydroxyvitamin D following sublingual and capsular vitamin D preparations.European journal of clinical nutrition · 2019Trial
- Vitamin D: Physiology, Pharmacology and Clinical Evidence for Supplementation-A Narrative Review.Basic & clinical pharmacology & toxicology · 2026Review
- Vitamin D Deficiency and Replacement Challenges in Type 1 Gastric Neuroendocrine Tumors: A Comparative Study.Nutrients · 2026Article
- Improved bioavailability of buccal nanoemulsion vitamin D compared to conventional oral supplementation in patients with inflammatory bowel disease: a randomized controlled trial.Frontiers in medicine · 2025Article
- Comparative bioavailability study of supplemental oral SucrosomialFrontiers in nutrition · 2024Article
- A comparative absorption study of sucrosomialFrontiers in nutrition · 2023Article
- Can We Structure Biomaterials to Spray Well Whilst Maintaining Functionality?Bioengineering (Basel, Switzerland) · 2022Review
- Nutraceutical Approaches to Dyslipidaemia: The Main Formulative Issues Preventing Efficacy.Nutrients · 2022Review
- Implementation strategies for improving vitamin D status and increasing vitamin D intake in the UK: current controversies and future perspectives: proceedings of the 2nd Rank Prize Funds Forum on vitamin D.The British journal of nutrition · 2022Article
- Tipping the Balance: Vitamin D Inadequacy in Children Impacts the Major Gut Bacterial Phyla.Biomedicines · 2022Article
- Effects of Oral Multi-Vitamin Multi-Mineral Supplement Formulations on Laboratory Outcomes and Quality of Life: A Quasi-Experimental Study.Frontiers in nutrition · 2022Article
- Vitamin D supplementation in childhood asthma: a systematic review and meta-analysis of randomised controlled trials.ERJ open research · 2022Article
- Changes in Metabolic Parameters in Patients with Diabetic Kidney Disease Depending on the Status of D3.Reviews on recent clinical trials · 2022Review
- Vitamin D levels of the healthy infants using oral spray or drop form of vitamin D supplement in the first year of life.Northern clinics of Istanbul · 2021Article
- SUBLINGUAL VITAMIN DAACE clinical case reportsArticle
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
4 authors at 1 institution in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundVitamin 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 D3 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.
methodsAn 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.
resultsIn 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).
conclusionIt 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
trial registrationCTRI/2013/06/003770.
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Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.