Evidence map›Paper›PMID 31485804›Full record

Trial reportPharmaceutical research2019

Food, Acid Supplementation and Drug Absorption - a Complicated Gastric Mix: a Randomized Control Trial.

Dalga D Surofchy, Lynda A Frassetto, Leslie Z Benet

Registry-linked trialOpen access · greenAbstract readRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Pharmaceutical research, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02758015 (Countering the Gastric ph Effect of a Standardized Meal in Healthy Volunteers Using Clinical Doses of Betaine Hydrochloride), which is not on this map. Cited by 4 papers.

0numbers the graph read from it
0cells of the map it votes in
4citing papers in PubMed
0.3field-weighted citation impact, top 37% 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.

NCT02758015 nacompletednot on this map

Countering the Gastric ph Effect of a Standardized Meal in Healthy Volunteers Using Clinical Doses of Betaine Hydrochloride

TypeinterventionalSponsorUniversity of California, San FranciscoRan2016 to 2018Enrolled9ConditionsHealthyArmsStandardized Meal, Betaine Hydrochloride 1500mg, Betaine Hydrochloride 3000mg, Betaine Hydrochloride 4500mg
3 · Its place in the literature

Who cites it

4 citing papers in PubMed, 6 citations in OpenAlex.

  1. Review
  2. Review
  3. Review
  4. 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

3 authors at 1 institution in 1 country.

Dalga D SurofchySchool of Pharmacy, University of California San Francisco, San Francisco, CA, USA.
Lynda A FrassettoSchool of Medicine, University of California San Francisco, San Francisco, CA, USA.
Leslie Z BenetDepartment of Bioengineering and Therapeutic Sciences, University of California San Francisco, 533 Parnassus Avenue, U-68, San Francisco, 94143-0912, CA, USA. leslie.benet@ucsf.edu.ORCID http://orcid.org/0000-0002-9678-2371
University of California, San Francisco · US

Funding

Engaging University of California Stakeholders for Biorespository ResearchUL1TR000004 · NCATS · UNIVERSITY OF CALIFORNIA, SAN FRANCISCO · PI GRANDIS, JENNIFER RUBIN · 2012 to 2015
$78.0M
NCATS NIH HHS UL1 TR000004
6 · The paper itself

Abstract

purposeThe purpose of this study was to determine the impact of food on gastric pH and the ability of over the counter betaine hydrochloride (BHCl) acid to reacidify gastric pH after food-induced elevations in gastric pH.

methodsThis open-label cross over clinical study (NCT02758015) included 9 subjects who were randomly assigned to one of 16 possible, 4-period cross-over sequences to determine the impact and relationship of food and gastric pH with acid supplementation. Subjects were administered various doses (1500 mg, 3000 mg and 4500 mg) of betaine hydrochloride (BHCl) to determine the ability of acid supplementation to reacidify gastric pH after the elevation of gastric pH caused by the ingestion of food.

resultsFollowing the administration of food and the resulting elevation in gastric pH, time to return to baseline gastric pH levels without acid supplementation was 49.7 ± 14.0 min. Administering 4500 mg of BHCl acid in capsules was able to reacidify gastric pH levels back to baseline following the administration of food in approximately 17.3 ± 5.9 min. AUC

conclusionThe ability of food to elevate and maintain gastric pH levels in the presence of acid supplementation was made evident throughout the study. A 4500 mg dose of BHCl was required to reacidify gastric pH after the administration of food. This study details the difficulty faced by clinicians in dosing a poorly soluble, weakly basic drug to patients receiving acid reducing agents where administration with food is recommended to avoid gastric side effects.

trial registrationhttps://clinicaltrials.gov/ct2/show/NCT02758015.

Indexed as

FoodGastric AbsorptionAdministration, OralAdolescentAdultBetaineCross-Over StudiesFemaleFood-Drug InteractionsGastric AcidGastric Acidity DeterminationGastrointestinal AgentsHumansHydrogen-Ion ConcentrationMaleMiddle AgedBetaineGastrointestinal AgentsPharmaceutical Preparationsbetaine hydrochloridegastric pHgastric reacidificationmeal effects

Identifiers

PMID31485804
PMCPMC7484952
OpenAlexW2971818125

What OpenQuestion holds

Textmetadata
LicenceTDM
Read underepoch 390

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.