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A Study to Assess the Effect of a 3-month Folate Supplementation on Systemic Homocysteine Plasma Concentration and Ocular Blood Flow in Patients With Diabetes

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT03997032
Recruitment Status : Completed
First Posted : June 25, 2019
Last Update Posted : June 25, 2019
Aprofol AG
Information provided by (Responsible Party):
Gerhard Garhofer, Medical University of Vienna

Brief Summary:

There is evidence that a folate deficiency - and as the biological consequence of the latter - higher homocysteine plasma levels are associated with an increased risk of vascular associated diseases. For the eye, it has been shown that higher intake of folate reduces the risk of vascular related diseases such as age related macular degeneration. Further studies suggest that decreased serum levels of folate and vitamin B12 may be an independent risk factor for diabetic retinopathy. The reason for the association of low folate levels and the increased risk for vascular-associated ocular diseases is not entirely clear but may be at least partially related to an impairment of local blood flow regulation in these patients.

Whether supplementation with folate may improve vascular regulation has not yet been sufficiently investigated. However, given that the potential effect size of a folate substitution on blood flow and systemic blood parameters is unclear, a proper statistical design for a large, controlled, randomized study is difficult. Thus, the present pilot study should (1) provide information about the homocysteine lowering potential of the formulation under study and (2) identify potential vascular related outcome parameters for further, larger, placebo-controlled studies and provide sufficient data to allow for a proper statistical planning for such a study.

Consequently, the current study seeks to investigate the effect of a 3-month supplementation with folate on systemic homocysteine plasma levels. Further, ocular blood flow and endothelial function in the ocular microcirculation will be assessed. For this purpose, a group of 25 patients with diabetes mellitus will be included in the study. Outcome parameters will be assessed at baseline and after a 3-month supplementation with folate.

Condition or disease Intervention/treatment Phase
Diabetes Dietary Supplement: Ocufolin Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 25 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: A Pilot Study to Assess the Effect of a 3-month Folate Supplementation on Systemic Homocysteine Plasma Concentration and Ocular Blood Flow in Patients With Diabetes
Actual Study Start Date : July 31, 2017
Actual Primary Completion Date : March 12, 2018
Actual Study Completion Date : July 17, 2018

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: Patients with Diabetes
Patients with Type 1 or Type 2 Diabetes
Dietary Supplement: Ocufolin
Ocufolin, Aprofol AG, Switzerland Dose: 1 capsule per day

Primary Outcome Measures :
  1. Plasma homocysteine level [ Time Frame: Change from Baseline plasma homocysteine level at 3 months ]
    Laboratory analysis for plasma homocysteine level in µmol/L

Secondary Outcome Measures :
  1. Retinal blood flow [ Time Frame: Change from Baseline retinal blood flow at 3 months ]
    Retinal blood flow will be assessed using Fourier domain optical coherence tomography, providing values in µl/min

  2. Retinal vessel diameters [ Time Frame: Change from Baseline retinal vessel diameters at 3 months ]

Other Outcome Measures:
  1. Intraocular pressure [ Time Frame: Change from Baseline intraocular pressure at 3 months ]
    Intraocular pressure will be assessed using Goldmann Applanation Tonometry, values will be provided in mmHg

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Age ≥ 18 years
  • Diabetes mellitus type 1 or 2
  • No or mild non-proliferative diabetic retinopathy
  • Normal findings in the medical history except diabetes unless the investigator considers an abnormality to be clinically irrelevant
  • Normal ophthalmic findings except mild non-proliferative retinopathy
  • Ametropy ≤ 6 diopters

Exclusion Criteria:

  • Participation in a clinical trial in the 3 weeks preceding the screening visit
  • Symptoms of a clinically relevant illness in the 3 weeks before the first study day
  • Presence or history of a severe medical condition relevant to the study, except diabetes, as judged by the clinical investigator
  • Intake of dietary supplements containing folate within the three months before the screening visit
  • Untreated or uncontrolled arterial hypertension (defined as either systolic blood pressure >150 mmHg or diastolic blood pressure >95 mmHg)
  • Blood donation during the previous three weeks
  • Moderate to severe non-proliferative or proliferative diabetic retinopathy
  • Previous laser photocoagulation treatment
  • History or family history of epilepsy
  • Presence of any abnormalities preventing reliable measurements in the study eye as judged by the investigator
  • Best corrected visual acuity < 0.8 Snellen
  • Ametropy > 6 Dpt
  • Pregnancy, planned pregnancy or lactating

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03997032

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Department of Clinical Pharmacology, Medical University of Vienna
Vienna, Austria, 1090
Sponsors and Collaborators
Medical University of Vienna
Aprofol AG
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Gerhard Garhofer, Principal Investigator, Medical University of Vienna Identifier: NCT03997032    
Other Study ID Numbers: 23022017
First Posted: June 25, 2019    Key Record Dates
Last Update Posted: June 25, 2019
Last Verified: June 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases