Efficacy and Safety of Vitamin D3 (Cholecalciferol) Oral Solution Compared to Tablet and Capsule: A Randomized, Parallel-Design, Active-Controlled Study

Efficacy and Safety of Vitamin D3 (Cholecalciferol) Oral Solution Compared to Tablet and Capsule: A Randomized, Parallel-Design, Active-Controlled Study

Krishnakumar M Nandgaye

Contact

Santoshi B. Kadam

Contact

Dr. Prashant J. Palkar

Contact

Efficacy and Safety of Vitamin D3 (Cholecalciferol) Oral Solution Compared to Tablet and Capsule: A Randomized, Parallel-Design, Active-Controlled Study

Article Fingerprint

ReserarchID

PDDTM15LY2

AI TAKEAWAY

Connecting with the Eternal Ground

Abstract

We performed a study to compare the efficacy of Vitamin D 3 oral solution with a conventional tablets and capsules in hypovitaminosis D patients. One hundred eighty subjects were divided into three different groups and received vitamin D 3 60000 IU per week for eight weeks either in the form of an oral solution or a tablet or a capsule. A significant increase in serum 25(OH)D was observed in vitamin D 3 oral solution from baseline (P=0.0001) as compared to a tablet (P=0.0001) and capsule (P=0.0001). A significant decrease in iPTH levels was seen in the vitamin D 3 oral solution group from baseline (P=0.0001) and also as compared to a tablet (P=0.0001) and capsule (P=0.0001). Oral solution of vitamin D 3 is a nanotechnology-based formulation which was found to be effective and safe. Thus, treatment with vitamin D 3 oral solution in hypovitaminosis D patients may result in faster and higher improvement in the normalization of vitamin D levels.

References

21 Cites in Article

Reference Format

Roberto Cesareo,Alberto Falchetti,Roberto Attanasio,Gaia Tabacco,Anda Naciu,Andrea Palermo (2019). Hypovitaminosis D: Is It Time to Consider the Use of Calcifediol?.
D Caccamo,S Ricca,M Currò,R Ientile (2018). Health Risks of Hypovitaminosis D: A Review of New Molecular Insights.
Sara Schramm,Harald Lahner,Karl-Heinz Jöckel,Raimund Erbel,Dagmar Führer,Susanne Moebus (2017). Impact of season and different vitamin D thresholds on prevalence of vitamin D deficiency in epidemiological cohorts—a note of caution.
Martin Gaksch,Rolf Jorde,Guri Grimnes,Ragnar Joakimsen,Henrik Schirmer,Tom Wilsgaard,Ellisiv Mathiesen,Inger Njølstad,Maja-Lisa Løchen,Winfried März,Marcus Kleber,Andreas Tomaschitz,Martin Grübler,Gudny Eiriksdottir,Elias Gudmundsson,Tamara Harris,Mary Cotch,Thor Aspelund,Vilmundur Gudnason,Femke Rutters,Joline Beulens,Esther Van ‘t Riet,Giel Nijpels,Jacqueline Dekker,Diana Grove-Laugesen,Lars Rejnmark,Markus Busch,Gert Mensink,Christa Scheidt-Nave,Michael Thamm,Karin Swart,Ingeborg Brouwer,Paul Lips,Natasja Van Schoor,Christopher Sempos,Ramón Durazo-Arvizu,Zuzana Škrabáková,Kirsten Dowling,Kevin Cashman,Mairead Kiely,Stefan Pilz (2017). Vitamin D and mortality: Individual participant data meta-analysis of standardized 25-hydroxyvitamin D in 26916 individuals from a European consortium.
S Pilz,M Grübler,M Gaksch,V Schwetz,C Trummer,B Hartaigh,N Verheyen,A Tomaschitz,W März (2016). Vitamin D and Mortality.
Markus Herrmann,Christopher-John L. Farrell,Irene Pusceddu,Neus Fabregat-Cabello,Etienne Cavalier (2017). Assessment of vitamin D status – a changing landscape.
Yogita Dhas,Neetu Mishra,Joyita Banerjee (2017). Vitamin D Deficiency and Oxidative Stress in Type 2 Diabetic Population of India.
R Nair,A Maseeh (2012). Vitamin D: The "sunshine" vitamin.
Laura Tripkovic,Helen Lambert,Kathryn Hart,Colin Smith,Giselda Bucca,Simon Penson,Gemma Chope,Elina Hyppönen,Jacqueline Berry,Reinhold Vieth,Susan Lanham-New (2012). Comparison of vitamin D2 and vitamin D3 supplementation in raising serum 25-hydroxyvitamin D status: a systematic review and meta-analysis.
Vaibhav Maurya,Manjeet Aggarwal (2017). Enhancing Bio-Availability of Vitamin D by Nano-Engineered Based Delivery Systems- An Overview.
C Bothiraja,A Pawar,G Deshpande (2016). Ex-vivo absorption study of a nanoparticle based novel drug delivery system of vitamin D3 (Arachitol Nano™) using everted intestinal sac technique.
Foo Hom,John Miskel (1970). Oral Dosage form Design and its Influence on Dissolution Rates for a Series of Drugs.
Krishnakumar Nandgaye,Rajaram Samant,Santoshi Kadam,Prashant Palkar (2019). Relative oral bioavailability of three formulations of vitamin D3: An open-label, three-treatment study.
A Ross,C Taylor,A Yaktine (2011). Dietary Reference Intakes for Calcium and Vitamin D.
K Manek (2017). Evaluation of efficacy of a nanoparticle based vitamin D formulation in correction of vitamin D levels in patients with documented deficiency or insufficiency of vitamin D.
(2018). Advantages and Limitations of Oral Stem Cell use for Oral Tissue Replacement.
U Moghis,Shoukath Ahmad,Imran Ali,Ahmad (2012). Application of nanotechnology in pharmaceutical development.
H Biesalaski (1991). Bioavavilability of Vitamin A.
E Jacquemin,B Hermeziu,Y Kibleur,I Friteau,D Mathieu,F Le Coz,D Moyse,M Gérardin,E Jacqz-Aigrain,A Munck (2009). Bioavailability of oral vitamin E formulations in adult volunteers and children with chronic cholestasis or cystic fibrosis.
Fusheng Sun,Chuanxia Ju,Jiahong Chen,Sai Liu,Na Liu,Keke Wang,Chenguang Liu (2012). Nanoparticles Based on Hydrophobic Alginate Derivative as Nutraceutical Delivery Vehicle: Vitamin D<sub>3</sub>Loading.
Raman Marwaha,Tanvi Dev,Ambrish Mittal,Kalaivani Mani,Archna Narang,Preeti Arora,Anne Singh,Aditi Chadha,Navin Dang,Meetu Goel,Vinod Sharma,Gomathy Sethuraman (2019). A randomised controlled trial comparing the efficacy of micellised and fat-soluble vitamin D<sub>3</sub> supplementation in healthy adults.

Download References

Funding

No external funding was declared for this work.

Conflict of Interest

The authors declare no conflict of interest.

Ethical Approval

No ethics committee approval was required for this article type.

Data Availability

Not applicable for this article.

How to Cite This Article

Krishnakumar M Nandgaye. 2020. \u201cEfficacy and Safety of Vitamin D3 (Cholecalciferol) Oral Solution Compared to Tablet and Capsule: A Randomized, Parallel-Design, Active-Controlled Study\u201d. Global Journal of Medical Research - B: Pharma, Drug Discovery, Toxicology & Medicine GJMR-B Volume 20 (GJMR Volume 20 Issue B5).

More Citation Formats

Select Citation Style:

Download Citation

GJMR Volume 20 Issue B5

Explore Journals Explore Volume Read This Issue

Journal Specifications

Crossref Journal DOI 10.17406/gjmra

Print ISSN 0975-5888

e-ISSN 2249-4618

Keywords

Not Found

Classification

GJMR-B Classification NLMC Code: QV 701

Submission ReceivedDecember 15, 2019
Peer Review Double Blind
Handling Editor
Accepted January 5, 2020
Published January 15, 2020

Version of record

v1.2

Issue date

July 27, 2020

Language

Experiance in AR

Explore published articles in an immersive Augmented Reality environment. Our platform converts research papers into interactive 3D books, allowing readers to view and interact with content using AR and VR compatible devices.

View in VR

Read in 3D

Your published article is automatically converted into a realistic 3D book. Flip through pages and read research papers in a more engaging and interactive format.

View in 3D

Article Matrices

Total Views: 2340

Total Downloads: 1145

2026 Trends

Our website is actively being updated, and changes may occur frequently. Please clear your browser cache if needed. For feedback or error reporting, please email [email protected]