Evidence map›Paper›PMID 31618812›Full record

Trial reportNutrients2019

Antioxidant Saffron and Central Retinal Function in ABCA4-Related Stargardt Macular Dystrophy.

Marco Piccardi, Antonello Fadda, Francesco Martelli, Dario Marangoni, Adriano Magli, Angelo M Minnella, Matteo Bertelli, Stefano Di Marco, Silvia Bisti, Benedetto Falsini

Registry-linked trialAbstract 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. It is linked to trial NCT01278277 (A Novel Therapeutic Strategy Targeting Photoreceptor Oxidative Damage in ABCR-related Retinal Degenerations), which is not on this map. Cited by 34 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
34citing papers in PubMed, 2 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.

NCT01278277 phase1 / phase2unknown statusnot on this map

A Novel Therapeutic Strategy Targeting Photoreceptor Oxidative Damage in ABCR-related Retinal Degenerations

TypeinterventionalSponsorCatholic University of the Sacred HeartRan2011 to 2017Enrolled30ConditionsRetinal Degeneration, Genetic Disease, Single-Gene Defects, Macular DystrophyArmsSaffron supplementation, placebo
3 · Its place in the literature

Who cites it

34 citing papers in PubMed, 2 syntheses or guidelines pooled it.

  1. Pooled it
  2. DoesJournal of evidence-based integrative medicine
    Pooled it
  3. Trial
  4. Adverse Events of Saffron (Health science reports · 2026
    Article
  5. Review
  6. Review
  7. Review
  8. Article
  9. Review
  10. Review
  11. Review
  12. Medical hypothesis, discovery & innovation ophthalmology journal · 2024
    Review
  13. Article
  14. Article
  15. Review
  16. Review
  17. Article
  18. Review
  19. Review
  20. 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

10 authors.

Marco PiccardiDipartimento di Scienze dell'Invecchiamento, Neurologiche, Ortopediche e della Testa-Collo, Fondazione Policlinico Universitario A. Gemelli- IRCCS, 00168 Rome, Italy. piccmarc@tiscali.it.
Antonello FaddaDipartimento di Malattie Cardiovascolari, endocrino-metaboliche e invecchiamento, Istituto Superiore di Sanità, 00168 Rome, Italy. afadda@iss.it.
Francesco MartelliDipartimento di Malattie Cardiovascolari, endocrino-metaboliche e invecchiamento, Istituto Superiore di Sanità, 00168 Rome, Italy. francesco.martelli@iss.it.ORCID 0000-0002-6963-8331
Dario MarangoniDipartimento di Scienze dell'Invecchiamento, Neurologiche, Ortopediche e della Testa-Collo, Fondazione Policlinico Universitario A. Gemelli- IRCCS, 00168 Rome, Italy. dariomarangoni80@yahoo.it.
Adriano MagliDipartimento di Oftalmologia Pediatrica, Università di Salerno, 84084 Salerno, Italy. amagli@unisa.it.
Angelo M MinnellaDipartimento di Scienze dell'Invecchiamento, Neurologiche, Ortopediche e della Testa-Collo, Fondazione Policlinico Universitario A. Gemelli- IRCCS, 00168 Rome, Italy. aminnella59@gmail.com.ORCID 0000-0001-5896-5313
Matteo BertelliLaboratorio di Genetica Medica e Biologia Molecolare, MAGI, 38068 Rovereto, Italy. matteo.bertelli@assomagi.org.
Stefano Di MarcoDipartimento di Scienze Cliniche Applicate e Biotecnologie, Università dell'Aquila, 67100 L'Aquila, Italy. stefano.dimarco@univaq.it.
Silvia BistiDipartimento di Scienze Cliniche Applicate e Biotecnologie, Università dell'Aquila, 67100 L'Aquila, Italy. s.bisti@team.it.
Benedetto FalsiniDipartimento di Scienze dell'Invecchiamento, Neurologiche, Ortopediche e della Testa-Collo, Fondazione Policlinico Universitario A. Gemelli- IRCCS, 00168 Rome, Italy. Benedetto.Falsini@unicatt.it.

Funding

Fondazione Telethon GGP10149
6 · The paper itself

Abstract

Retinal oxidative damage, associated with an ATP-binding cassette, sub-family A, member 4, also known as ABCA4 gene mutation, has been implicated as a major underlying mechanism for Stargardt disease/fundus flavimaculatus (STG/FF). Recent findings indicate that saffron carotenoid constituents crocins and crocetin may counteract retinal oxidative damage, inflammation and protect retinal cells from apoptosis. This pilot study aimed to evaluate central retinal function following saffron supplementation in STG/FF patients carrying ABCA4 mutations.

methodsin a randomized, double-blind, placebo-controlled study (clinicaltrials.gov: NCT01278277), 31 patients with ABCA4-related STG/FF and a visual acuity >0.25 were randomly assigned to assume oral saffron (20 mg) or placebo over a six month period and then reverted to P or S for a further six month period. Full ophthalmic examinations, as well as central 18° focal electroretinogram (fERG) recordings, were performed at baseline and after six months of either saffron or placebo. The fERG fundamental harmonic component was isolated by Fourier analysis. Main outcome measures were fERG amplitude (in µV) and phase (in degrees). The secondary outcome measure was visual acuity.

resultssupplement was well tolerated by all patients throughout follow-up. After saffron, fERG amplitude was unchanged; after placebo, amplitude tended to decrease from baseline (mean change: -0.18 log µV,

conclusionsshort-term saffron supplementation was well tolerated and had no detrimental effects on the electroretinographic responses of the central retina and visual acuity. The current findings warrant further long-term clinical trials to assess the efficacy of saffron supplementation in slowing down the progression of central retinal dysfunction in ABCA4-related STG/FF.

Indexed as

CrocusDietary SupplementsMutationAdministration, OralAdolescentAdultAgedAntioxidantsATP-Binding Cassette TransportersChildCross-Over StudiesDouble-Blind MethodElectroretinographyFemaleGenetic Predisposition to DiseaseHumansABCA4 protein, humanAntioxidantsATP-Binding Cassette TransportersABCA4 gene mutationantioxidantsfocal electroretinogramneuroprotectionpersonalized medicinephotoreceptorsretinal functionsaffron

Identifiers

PMID31618812
PMCPMC6835540

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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.