Evidence map›Paper›PMID 36407493›Full record

ArticleJournal of orthopaedics2023

An open-label, randomized, crossover study to evaluate the bioavailability of nanoemulsion versus conventional fat-soluble formulation of cholecalciferol in healthy participants.

Raman Kumar Marwaha, Manish Verma, Ajit Walekar, Rakesh Sonawane, Chirag Trivedi

Open access · hybridAbstract read
In one paragraph

Article in Journal of orthopaedics, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 4 papers.

0numbers the graph read from it
0cells of the map it votes in
4citing papers in PubMed
3.8field-weighted citation impact, top 7% of its field
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.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

4 citing papers in PubMed, 10 citations in OpenAlex.

  1. Trial
  2. Trial
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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 at 1 institution in 1 country.

Raman Kumar MarwahaConsultant Endocrinologist and President, Society of Endocrine Health Care for Elderly, Adolescents and Children (SEHEAC), 92E/I, Ground Floor, Munirka Market, New Delhi, 110067, India.
Manish VermaMedical Affairs, CHC, Sanofi India Limited, Sanofi House, CTS No.117-B, L&T Business Park, Saki Vihar Road, Powai, Mumbai, 400072, India.
Ajit WalekarClinical Study Unit, Sanofi Healthcare India Private Limited, Sanofi House, CTS No.117-B, L&T Business Park, Saki Vihar Road, Powai, Mumbai, 400072, India.
Rakesh SonawaneMedical Affairs, CHC, Sanofi India Limited, Sanofi House, CTS No.117-B, L&T Business Park, Saki Vihar Road, Powai, Mumbai, 400072, India.
Chirag TrivediClinical Study Unit, Sanofi Healthcare India Private Limited, Sanofi House, CTS No.117-B, L&T Business Park, Saki Vihar Road, Powai, Mumbai, 400072, India.
Sanofi (India) · IN

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Background: Nanoemulsion preparations of cholecalciferol available in the market claim to have better bioavailability than the conventional fat-soluble cholecalciferol. However, limited data are available in humans for such preparations. We, therefore, compared the relative bioavailability of two formulations of 60,000 IU cholecalciferol (nanoemulsion oral solution, water-miscible vitamin D3 [test] vs soft gelatin capsules [reference]) in healthy adult participants. Methods: In this randomized, open-label, two sequence, single-dose, two-way crossover study (CTRI/2018/05/013839), Indian participants aged 18-45 years received single dose of nanoemulsion and capsule formulations, under fasting conditions. Blood samples collected over 120 h were assessed to determine cholecalciferol concentrations. Pharmacokinetic parameters (area under the concentration-time curve up to 120 h [AUC Results: Among the 24 eligible participants, the relative bioavailability of nanoemulsion was significantly higher than the capsules by 36% (p = 0.0001) based on AUC Conclusions: Nanoemulsion oral solution of cholecalciferol showed a greater bioavailability compared with soft gelatin capsules, under fasting conditions, in healthy human participants.

Indexed as

AbsorptionArea under curveBiological availabilityLipid digestionNanotechnologyTherapeutic equivalencyVitamin D deficiency

Identifiers

PMID36407493
PMCPMC9672879
OpenAlexW4308348480

What OpenQuestion holds

Textmetadata
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Registered trials

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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.