Vitamin D deficiency (VDD) is a common metabolic/endocrine abnormality and a global public health problem due to lack of exposure to sunlight, inadequate nutritional intake, malabsorption syndrome, and increased skin pigmentation.
To achieve and maintain adequate circulatory Vit D levels, over-the-counter Vit D supplements are often consumed.
Vit D3 supplement is usually administered orally and produced in various forms, such as oral drops, tablets, soft gel capsules (SGC), and injectable oily solutions.
However, the authors of the current study say that despite the widespread consumption of Vit D supplements for treating VDD, the absorption (and hence efficacy) of different formulations has not been well studied.
Vit D, being a fat-soluble vitamin, and its absorption in the intestinal mucosa is highly dependent on its food/delivery matrix dissolution in the gastrointestinal (GI) fluid and the integrity of the intestinal wall.
The absorption is further limited by multiple factors including the physiochemical state of Vit D3 food/delivery matrix, Vit D interaction with other compounds in the food such as cholesterol, fatty acids, and dietary fibers, and factors associated with humans such as malabsorption syndrome, other chronic diseases, age, medication use, surgery, obesity, and genetic variation.
To overcome this, the development of more bio-accessible delivery vehicles can enhance absorption such as oral phospholipids-sucrester matrix delivery vehicle, also known as sucrosomial technology.
The present study therefore aimed to assess the GI absorption (hence efficacy) of a high-dose (200,000 IU) supplementation of an Vit D3 formulation vs. a reference marketed chewable tablet and soft gel capsule (SGC) Vit D3 formulation in raising circulatory 25(OH)D levels, as well as safety, and tolerability in Vit D deficient but otherwise healthy adults.
The authors hypothesised that the unique structural, physiochemical, and pharmacokinetic characteristics of the sucrosomial Vit D3 preparation could offer several advantages over the conventional oral Vit D3 formulations such as stability in the GI tract, efficient intestinal absorption, increased Vit D3 bioavailability, and improved patient compliance, particularly in paediatric and geriatric patients, and those with malabsorption syndrome.
They conclude that the sucrosomial Vit D3 was indeed more efficacious in raising the circulating 25(OH)D levels owing to its efficient absorption.
The state: "According to the results of our study, the sucrosomial orodispersible Vit D3 preparation dissolves and absorbs efficiently in the GI system, leading to adequately higher and sustained circulatory Vit D levels as compared to a chewable tablet and soft gel capsule forms of Vit D3 preparations in Vit D-deficient healthy adults, and thus could contribute effectively to body protection against diseases associated with VDD."
The study
This was a prospective, parallel group, open-label, randomized clinical study conducted at Bolan Medical Complex Hospital (BMCH), Quetta, and Lady Reading Hospital (LRH), Pakistan, from February 2023 to April 2023.
This exploratory study assessed the absorption of a new phospholipids-sucrester matrix delivery vehicle-based (sucrosomial) orodispersible Vit D3 (Surosomial UltraD3 Cholecalciferol 100,000 IU, Alesco srl, Italy, patent number WO 2021/111404) supplement compared to a randomly selected reference chewable tablet (Admore, Biolex, Cholecalciferol 100,000 IU, Pharma, PK) in study one and SGC (Opt-D, Cholecalciferol 200,000 IU, PharmEvo, PK) Vit D3 supplements in study two.
Participants were randomly allocated to one group and given a single weekly dose of 200,000 IU (same day and same time) of the supplement for three consecutive weeks.
Follow-up serum 25(OH)D levels were evaluated after 2, 3, and 6 weeks.
In study one, follow-up serum 25(OH)D levels measured during Vit D3 treatment in both groups. After two weeks of Vit D3 treatment, both groups showed a significant increase in the serum 25(OH)D levels (p < 0.0001) but rose substantially higher in the sucrosomial Vit D3 group, with a statistically significant difference between the two groups
In study two, sucrosomial Vit D3 supplementation led to a substantial increase in follow-up serum 25(OH)D levels as compared to the SGC Vit D3 supplement, which showed only a mild increase.
Sucrosomial Technology
The report explains that Vit D3 in the sucrosomial formulation is protected by a phospholipids, made mainly from sunflower lecithin plus a sucrester (sucrose ester) matrix.
"Additional stability and coating are achieved thanks to the presence of other ingredients as starch and tricalcium phosphate and forming a “sucrosome” delivery vehicle. The gastro-resistant properties of sucrosome are believed to protect Vit D3 from degradation through its journey in the GI tract, decrease its interactions with food in the stomach, and promote transport and absorption across the intestinal epithelium to the circulatory system. The intact sucrosome allows the Vit D3 to reach the intestinal mucosa where it is absorbed as a vesicle-like structure through para-cellular and trans-cellular (M-cells) routes."
Source: Nutrients
Volume 10 - 2023 | https://doi.org/10.3389/fnut.2023.1221685
"A comparative absorption study of sucrosomial orodispersible vitamin D3 supplementation vs. a reference chewable tablet and soft gel capsule vitamin D3 in improving circulatory 25(OH)D levels in healthy adults with vitamin D deficiency—Results from a prospective randomized clinical trial"
Authors: Bano A, Abrar S, Brilli E, Tarantino G, Bugti AA, Fabbrini M, Conti G, Turroni S, Bugti M, Afridi F, Mureed S, Zada H, Din Ujjan I, Ashraf S, Ghafoor A, Khan S and Khan A (2023)