Evidence map›Paper›PMID 30917531›Full record

Trial reportNutrients2019

Pharmacokinetics of a New Pharmaceutical Form of Vitamin D3 100,000 IU in Soft Capsule.

Romuald Mentaverri, Jean-Claude Souberbielle, Gilles Brami, Christelle Daniel, Patrice Fardellone

Open access · goldAbstract readRandomized Controlled Trial
In one paragraph

Trial report in Nutrients, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 7 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
7citing papers in PubMed, 1 pooled it
0.9field-weighted citation impact, top 26% 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

7 citing papers in PubMed, 1 synthesis or guideline pooled it, 8 citations in OpenAlex.

  1. Efficacy of Vitamin DNutrients · 2020
    Pooled it
  2. Trial
  3. Trial
  4. A comparative absorption study of sucrosomialFrontiers in nutrition · 2023
    Article
  5. Article
  6. Article
  7. Article
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 2 institutions in 1 country.

Romuald MentaverriLaboratoire de Biologie Humaine, CHU Amiens-Picardie, Biologie Endocrinienne et Osseuse 1, 80 054 Amiens, France. mentaverri.romuald@chu-amiens.fr.
Jean-Claude SouberbielleService des Explorations Fonctionnelles, hôpital Necker-Enfants Malades, 75 015 Paris, France. souberjc@outlook.fr.
Gilles BramiLaboratoires IPRAD 174/178 quai de Jemmapes, 75 010 Paris, France. g.brami@iprad.com.
Christelle DanielLaboratoires IPRAD 174/178 quai de Jemmapes, 75 010 Paris, France. c.daniel@iprad.com.
Patrice FardelloneEA 7517, Centre de Recherche Universitaire en Santé de l'UPJV, site Hôpital Sud, 80 054 Amiens, France. fardellone.patrice@chu-amiens.fr.ORCID 0000-0003-3535-3060
Centre Hospitalier Universitaire Amiens-Picardie · FRHôpital Necker-Enfants Malades · FR

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Vitamin D deficiency is frequent in the general population and both subjects and health professionals could benefit from a broader range of vitamin D3 formulations. We conducted a single-dose, open-label, parallel-group, randomized bioequivalence study to compare a single dose of a newly developed vitamin D3 100,000 IU in a soft capsule (Group 1) with the reference drug vitamin D3 100,000 IU oral solution in ampoule (Group 2) in healthy volunteers over a four-month period. The primary endpoint was the area under the curve (AUC) of serum 25-hydroxyvitamin-D (25(OH)D) concentrations on Day 112. This study was conducted in France from February to June 2014 in 53 young adults with a mean age of 26.9 years. At baseline, low mean serum 25(OH)D levels were observed in both groups (10.6 ng/mL in Group 1 and 9.0 ng/mL in Group 2). On Day 112, the AUC of serum 25(OH)D concentration was 2499.4 ± 463.8 nmol/mL (7.8 ± 0.2 for LogAUC) for Group 1 and 2152.3 ± 479.8 nmol/mL (7.6 ± 0.2 for LogAUC) for Group 2. Bioequivalence of the two treatments was not demonstrated. Superiority of vitamin D3 100,000 IU soft capsule was observed with

Indexed as

AdultCalcium-Regulating Hormones and AgentsCapsulesCholecalciferolFemaleHumansMaleTherapeutic EquivalencyYoung AdultCalcium-Regulating Hormones and AgentsCapsulesCholecalciferol100,000 IU soft capsule25(OH)Doral supplementationpharmacokineticssingle dosevitamin D

Identifiers

PMID30917531
PMCPMC6470992
OpenAlexW2923747247

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

None linked

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.