Evidence map›Paper›PMID 16015255›Full record

Trial reportEuropean journal of clinical nutrition2005

Changes in cholesterol and triglyceride concentrations in the Vanguard population of the Carotene and Retinol Efficacy Trial (CARET).

B Cartmel, J Dziura, M R Cullen, S Vegso, G S Omenn, G E Goodman, C A Redlich

Abstract readRandomized Controlled Trial
PubMed Publisher
In one paragraph

Trial report in European journal of clinical nutrition, 2005. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 10 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
10citing papers in PubMed, 1 pooled it
0.7field-weighted citation impact, top 38% 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

10 citing papers in PubMed, 1 synthesis or guideline pooled it, 24 citations in OpenAlex.

  1. Antioxidant supplements for preventing gastrointestinal cancers.The Cochrane database of systematic reviews · 2008
    Pooled it
  2. Article
  3. Article
  4. Review
  5. Article
  6. Review
  7. Review
  8. Article
  9. Article
  10. 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

7 authors at 4 institutions in 1 country.

B CartmelDepartment of Epidemiology and Public Health and the Yale Cancer Center, Yale University School of Medicine, New Haven, CT 06510, USA. brenda.cartmel@yale.edu
J Dziura
M R Cullen
S Vegso
G S Omenn
G E Goodman
C A Redlich
Yale University · USYale Cancer Center · USCancer Research Center · USUniversity of Michigan–Ann Arbor · US

Funding

THE CAROTENE AND RETINOL EFFICACY TRIAL (CARET)U01CA063673 · NCI · FRED HUTCHINSON CANCER RESEARCH CENTER · PI GOODMAN, GARY E · 1994 to 2006
$13.0M
CARET--THE BALTIMORE STUDY CENTERU01CA048196 · NCI · UNIVERSITY OF MARYLAND BALTIMORE · PI KEOGH, JAMES P · 1994 to 1996
–
CARET--STUDY CENTERU01CA048200 · NCI · YALE UNIVERSITY · PI CULLEN, MARK RICHARD · 1994 to 1996
–
CARET--THE CAROTENE AND RETINOL EFFICACY TRIALU01CA047989 · NCI · UNIVERSITY OF CALIFORNIA SAN FRANCISCO · PI BALMES, JOHN R · 1994 to 1996
–
CARET--THE CAROTENE AND RETINOL EFFICACY TRIALU01CA052596 · NCI · UNIVERSITY OF CALIFORNIA IRVINE · PI MEYSKENS, FRANK LOUIS · 1995 to 1996
–
CARET: THE SEATTLE STUDY CENTERU01CA063674 · NCI · FRED HUTCHINSON CANCER RESEARCH CENTER · PI GOODMAN, GARY E · 1994 to 1996
–
CARET--STUDY CENTERU01CA048203 · NCI · KAISER FOUNDATION RESEARCH INSTITUTE · PI VALANIS, BARBARA G. · 1994 to 1996
–
NCI NIH HHS U01 CA47989NCI NIH HHS U01 CA48196NCI NIH HHS U01 CA48200NCI NIH HHS U01 CA48203NCI NIH HHS U01 CA52596NCI NIH HHS U01 CA63673NCI NIH HHS U01 CA63674
6 · The paper itself

Abstract

backgroundThe Beta-Carotene and Retinol Efficacy Trial (CARET) was terminated 21 months ahead of schedule due to an excess of lung cancers. Deaths from cardiovascular disease also increased (relative risk=1.26 (95% confidence interval (CI) 0.99-1.61)) in the group assigned to a combination of 30 mg beta-carotene and 25 000 IU retinyl palmitate (vitamin A) daily. The basis for increased cardiovascular mortality is unexplained.

designWe analyzed data on serum lipids, available for 1474 CARET Vanguard participants who were enrolled in the two CARET pilot studies and transitioned to the Vanguard study. Total cholesterol and triglycerides were measured 2 months prior to, 4 and 12 months following randomization, and annually thereafter for up to 7 y.

interventionIn the asbestos-exposed pilot (N = 816), participants were assigned to beta-carotene and retinol or to placebo; in the smokers pilot (N = 1029), participants were assigned to beta-carotene, retinol, a combination, or placebo.

resultsSerum cholesterol showed a decline over time in both arms; serum triglycerides had a continuous decline over time in the placebo arm, but an initial increase that persisted in the active arm. Both serum cholesterol concentrations (P < 0.0003) and serum triglycerides (P < 0.0001) were significantly higher in the participants receiving vitamin A and/or a combination of vitamin A and beta-carotene (n = 863) as compared to the placebo group (n = 611). Those in this active intervention group had an average cholesterol concentration 5.3 mg/dl (0.137 mmol/l) higher than those in the placebo arm.

conclusionThe differences in cholesterol and triglyceride concentrations between the groups following randomization may account in part for the unexpected excess in cardiovascular deaths seen in the active intervention arm of CARET.

Indexed as

AntioxidantsAsbestosCardiovascular DiseasesCarotenoidsCholesterolDouble-Blind MethodFemaleHumansMaleMiddle AgedRisk FactorsSmokingTriglyceridesVitamin AAntioxidantsAsbestosCarotenoidsCholesterolTriglyceridesVitamin A

Identifiers

PMID16015255
OpenAlexW1976434290

What OpenQuestion holds

Textmetadata
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.