Oral intermittent vitamin D substitution: influence of pharmaceutical form and dosage frequency on medication adherence: a randomized clinical trial.
Adherence
Cholecalciferol
Dosage frequency
Formulation
Oral intermittent treatment
Preference
Journal
BMC pharmacology & toxicology
ISSN: 2050-6511
Titre abrégé: BMC Pharmacol Toxicol
Pays: England
ID NLM: 101590449
Informations de publication
Date de publication:
11 07 2020
11 07 2020
Historique:
received:
27
02
2020
accepted:
02
07
2020
entrez:
13
7
2020
pubmed:
13
7
2020
medline:
10
4
2021
Statut:
epublish
Résumé
To assess adherence to and preference for vitamin D substitution with different pharmaceutical forms and frequencies of administration. A focus group of stakeholders aimed at preparing the design of an interventional, randomized, cross-over study with 2 × 2 groups obtaining monthly or weekly vitamin D products in liquid or solid form for 3 months each. Dosage corresponds to cumulated amount of recommended 800 IU daily (5.600 IU weekly / 24.000 IU monthly). Main inclusion criteria were a vitamin D serum value < 50 nmol/l and age ≥ 18 years. Primary endpoint was adherence, secondary endpoints were preferences and vitamin D serum levels. The focus group reached consensus for preference of a monthly administration of solid forms to adults. Full datasets were obtained from 97 participants. Adherence was significantly higher with monthly (79.5-100.0%) than weekly (66.4-98.1%) administration. Vitamin D levels increased significantly (p < 0.001) in all participants. An optimal value of > 75 nmol/l was achieved by 32% after 3 months and by 50% after 6 months. Preferred formulation was solid form (tablets, capsules) for 71% of participants, and preferred dosage frequency was monthly for 39% of participants. Monthly oral vitamin D in solid form lead to the highest adherence, and is preferred by the participants. However, only one third of study participants achieved values in the optimal range of > 75 nmol/l cholecalciferol using weekly or monthly administration providing an average daily cholecalciferol dose of 800 IU. NCT03121593 | SNCTP000002251 . Registered 30. May 2017,. Prospectively registered.
Sections du résumé
BACKGROUND
To assess adherence to and preference for vitamin D substitution with different pharmaceutical forms and frequencies of administration.
METHODS
A focus group of stakeholders aimed at preparing the design of an interventional, randomized, cross-over study with 2 × 2 groups obtaining monthly or weekly vitamin D products in liquid or solid form for 3 months each. Dosage corresponds to cumulated amount of recommended 800 IU daily (5.600 IU weekly / 24.000 IU monthly). Main inclusion criteria were a vitamin D serum value < 50 nmol/l and age ≥ 18 years. Primary endpoint was adherence, secondary endpoints were preferences and vitamin D serum levels.
RESULTS
The focus group reached consensus for preference of a monthly administration of solid forms to adults. Full datasets were obtained from 97 participants. Adherence was significantly higher with monthly (79.5-100.0%) than weekly (66.4-98.1%) administration. Vitamin D levels increased significantly (p < 0.001) in all participants. An optimal value of > 75 nmol/l was achieved by 32% after 3 months and by 50% after 6 months. Preferred formulation was solid form (tablets, capsules) for 71% of participants, and preferred dosage frequency was monthly for 39% of participants.
CONCLUSIONS
Monthly oral vitamin D in solid form lead to the highest adherence, and is preferred by the participants. However, only one third of study participants achieved values in the optimal range of > 75 nmol/l cholecalciferol using weekly or monthly administration providing an average daily cholecalciferol dose of 800 IU.
TRIAL REGISTRATION
NCT03121593 | SNCTP000002251 . Registered 30. May 2017,. Prospectively registered.
Identifiants
pubmed: 32653031
doi: 10.1186/s40360-020-00430-5
pii: 10.1186/s40360-020-00430-5
pmc: PMC7353738
doi:
Substances chimiques
Dosage Forms
0
Vitamins
0
Vitamin D
1406-16-2
Banques de données
ClinicalTrials.gov
['NCT03121593']
Types de publication
Journal Article
Randomized Controlled Trial
Research Support, Non-U.S. Gov't
Langues
eng
Sous-ensembles de citation
IM
Pagination
51Subventions
Organisme : Abbott GmbH & Co
ID : TL-CLIN-094
Pays : International
Organisme : Verwaltungskommission des Fonds LOA IV/1
ID : not applicable
Pays : International
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