Vitamin E supplementation and macular degeneration: randomised controlled trial

Taylor, Hugh R professor
Tikellis, Gabriella research fellow
Robman, Luba D senior research fellow
McCarty, Catherine A associate professor
McNeil, John J professor

¹Centre for Eye Research Australia, University of Melbourne, Locked Bag 8, East Melbourne, Victoria, Australia, 8002, ²Department of Epidemiology and Preventive Medicine, Monash University, Room 306, Building ALF, Alfred Hospital, Caulfield, Victoria, Australia, 3145

Accepted for publication 9 January 2002

Contributors Contributors: HRT, GT, LDR, JJM, and CAM wrote the paper. JJM, HRT, Martha Sinclair, and the late Chris Silagy designed the study. JJM, HRT, CAM, LDR, Sinead K Garrett, MS, Flavia Cicuttini, Kath Ogden, and Adrian Thomas were members of the study's steering committee. The Data Safety and Monitoring Committee was chaired by the late Professor Chris Silagy. JJM, HRT, CAM were overall supervisors for the VECAT study. CAM was the trial epidemiologist. SKG was study coordinator. Hugo Stephenson designed and managed the software used for data collection. GT, LDR, and SKG conducted the study. Alex Harper was the external retinal consultant. LDR was the study ophthalmologist, was responsible for all fundus photography and clinical eye examinations, and was internal adjudicator for fundus grading. GT was responsible for all macular grading, development of grading protocol, participant interviews and medical examinations, and assessment of compliance to study protocol. Lynne Rodereda and Trudy Mai contributed to the data collection. LDR, GT, Kath Ogden, and Nicole Doherty contributed to the finalisation of the dataset. GT, LDR, and CAM (statistical supervisor) were responsible for data analysis. HRT is guarantor.

Correspondence to: H R Taylor [email protected]

Funding: The VECAT study was funded in part by grants from the National Health and Medical Research Council, the Jack Brockhoff Foundation, the Eirene Lucas Foundation, the Stoicesco Foundation, the Carleton Family Charitable Trust, Je Hope Knell Trust Fund, Smith and Nephew, Australia, and Henkel Australia.

Competing interests: None declared.

BMJ 325(7354):p 11, July 6, 2002.

Objective

To determine whether vitamin E supplementation influences the incidence or rate of progression of age related maculopathy (AMD).

Design

Prospective randomised placebo controlled clinical trial.

Setting

An urban study centre in a residential area supervised by university research staff.

Participants

1193 healthy volunteers aged between 55 and 80 years; 73% completed the trial on full protocol.

Interventions

Vitamin E 500 IU or placebo daily for four years.

Main outcome measures

Primary outcome: development of early age related macular degeneration in retinal photographs. Other measures included alternative definitions of age related macular degeneration, progression, changes in component features, visual acuity, and visual function

Results

The incidence of early age related macular degeneration (early AMD 3) was 8.6% in those receiving vitamin E versus 8.1% in those on placebo (relative risk 1.05, 95% confidence interval 0.69 to 1.61). For late disease the incidence was 0.8% versus 0.6% (1.36, 0.67 to 2.77). Further analysis showed no consistent differences in secondary outcomes.

Conclusion

Daily supplement with vitamin E supplement does not prevent the development or progression of early or later stages of age related macular degeneration.