Evidence map›Paper›PMID 32653031›Full record

Trial reportBMC pharmacology & toxicology2020

Oral intermittent vitamin D substitution: influence of pharmaceutical form and dosage frequency on medication adherence: a randomized clinical trial.

Jean-Pierre Rothen, Jonas Rutishauser, Philipp N Walter, Kurt E Hersberger, Isabelle Arnet

Registry-linked trialAbstract readRandomized Controlled Trial
In one paragraph

Trial report in BMC pharmacology & toxicology, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03121593, which is not on this map. Cited by 11 papers, 3 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
11citing papers in PubMed, 3 pooled it
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

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.

2 · The registry

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.

NCT03121593 no registry record found
3 · Its place in the literature

Who cites it

11 citing papers in PubMed, 3 syntheses or guidelines pooled it.

  1. Pooled it
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  3. Pooled it
  4. Trial
  5. Review
  6. Article
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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

5 authors.

Jean-Pierre RothenPharmaceutical Care Research Group, Department of Pharmaceutical Sciences, University of Basel, Petersplatz 14, Postfach 2148, CH-4001, Basel, Switzerland. jp.rothen@unibas.ch.ORCID 0000-0003-2807-2201
Jonas RutishauserDivision of Endocrinology, Diabetes, and Metabolism, University Hospital, Basel, Switzerland.
Philipp N WalterSolothurn Hospitals, Institute for Laboratory Medicine, Olten, Switzerland.
Kurt E HersbergerPharmaceutical Care Research Group, Department of Pharmaceutical Sciences, University of Basel, Petersplatz 14, Postfach 2148, CH-4001, Basel, Switzerland.
Isabelle ArnetPharmaceutical Care Research Group, Department of Pharmaceutical Sciences, University of Basel, Petersplatz 14, Postfach 2148, CH-4001, Basel, Switzerland.

Funding

Abbott GmbH & Co TL-CLIN-094Verwaltungskommission des Fonds LOA IV/1 not applicable
6 · The paper itself

Abstract

backgroundTo assess adherence to and preference for vitamin D substitution with different pharmaceutical forms and frequencies of administration.

methodsA 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.

resultsThe 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.

conclusionsMonthly 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 registrationNCT03121593 | SNCTP000002251 . Registered 30. May 2017,. Prospectively registered.

Indexed as

Dietary SupplementsMedication AdherenceAdministration, OralAgedCross-Over StudiesDosage FormsDrug Administration ScheduleFemaleFocus GroupsHumansMaleMiddle AgedVitamin DVitaminsDosage FormsVitamin DVitaminsAdherenceCholecalciferolDosage frequencyFormulationOral intermittent treatmentPreference

Identifiers

PMID32653031
PMCPMC7353738

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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.