The effect of a lutein based nutritional supplement on non-exudative age-related macular degeneration (AMD): a double-masked randomised controlled trial

ISRCTN	ISRCTN78467674
DOI	https://doi.org/10.1186/ISRCTN78467674
Secondary identifying numbers	N/A

Submission date: 20/06/2003
Registration date: 11/09/2003
Last edited: 11/01/2018

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Eye Diseases

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English Summary

Not provided at time of registration

Study website

Contact information

Miss Hannah Bartlett
Scientific

Neuroscience Research Institute
School of Life and Health Sciences
Aston University
Aston Triangle
Birmingham
B4 7ET
United Kingdom

Email	bartlehe@aston.ac.uk

Study information

Study design	Randomised controlled trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Not specified
Study type	Treatment
Scientific title	The effect of a lutein based nutritional supplement on non-exudative age-related macular degeneration (AMD): a double-masked randomised controlled trial
Study hypothesis	Age-related macular degeneration is the leading cause of blind registration in the developed world. One aetiological hypothesis involves oxidation and the intrinsic vulnerability of the retina to damage via this process. This has prompted interest in the role of antioxidants in the prevention and treatment of this eye disease.
Ethics approval(s)	Approved by the Aston University Human Sciences Ethical Committee.
Condition	Age-related macular degeneration
Intervention	The study formulation contains: Lutein 10 mg Vitamin C 250 mg Vitamin E 34 mg Vitamin A 750 µg Zinc 10 mg Copper 0.5 mg
Intervention type	Supplement
Primary outcome measure	1. Distance and near Visual Acuity (VA) measured using Bailey-Lovie logMAR charts 2. Contrast sensitivity (CS) measured using a Pelli-Robson chart 3. Colour vision measured using the PV-16 quantitative colour vision test 4. Macular Mapping (MM) test 5. Eger Macular Stressometer (EMS) used to assess glare recovery 6. Fundus photographs of the macular will be assessed using colour and edge analysis software Data collection will take place at baseline, nine, and 18 months.
Secondary outcome measures	Not provided at time of registration
Overall study start date	01/07/2003
Overall study end date	01/01/2005

Eligibility

Participant type(s)	Patient
Age group	Not Specified
Sex	Not Specified
Target number of participants	159
Participant inclusion criteria	1. Have to provide written informed consent 2. Have to be available for three visits to Aston University 3. Have to present with no ocular pathology in one eye, or no ocular pathology other than dry AMD in one eye. A cataract grading system consisting of grades one, two and three for each of cortical, nuclear, and posterior subcapsular cataracts has been developed. Participants presenting with lens opacities precluding fundus photography are excluded. Throughout the trial period, progression of any type of cataract to the successive grade will require the participant to withdraw.
Participant exclusion criteria	Exclusion criteria include type I and II diabetes because vitamin E has been shown to affect glucose tolerance and diabetic retinopathy may confound the results. Those taking Warfarin medication are excluded as zinc may decrease its absorption and activity, as are those who use nutritional supplements that potentially raise vitamin and mineral intake above safe limits. The most recent guidelines for upper limits of nutritional supplementation are set out in the UK Food Standards Agency report. Neovascular AMD and other ocular disease that could potentially interfere with the results are excluded.
Recruitment start date	01/07/2003
Recruitment end date	01/01/2005

Locations

Countries of recruitment

England
United Kingdom

Study participating centre

Neuroscience Research Institute

Birmingham
B4 7ET
United Kingdom

Sponsor information

Aston University (UK)
University/education

Neurosciences Research Institute
School of Life and Health Sciences
Aston Triangle
Birmingham
B4 7ET
England
United Kingdom

Website	http://www.aston.ac.uk/
"ROR"	https://ror.org/05j0ve876

Funders

Funder type

University/education

College of Optometrists (UK)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Protocol article	protocol	10/10/2003		Yes	No
Results article	results	01/04/2008		Yes	No

Editorial Notes

11/01/2018: publication reference added.