---
title: Effect of Homocysteine-lowering Therapy With Folic Acid, Vitamin B12, and Vitamin B6 on Endothelium-dependent Vasodilatation of Forearm Resistance Vessels in Patients With Coronary Heart Disease
nct_id: NCT00693589
overall_status: COMPLETED
phase: PHASE2
sponsor: Insel Gruppe AG, University Hospital Bern
study_type: INTERVENTIONAL
primary_condition: Cardiovascular Disease
canonical_url: "https://parkinsonspathways.com/agent/trials/NCT00693589.md"
clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT00693589"
ct_last_update_post_date: 2024-11-07
last_seen_at: "2026-05-12T06:03:07.085Z"
source: ClinicalTrials.gov (mirrored, no enrichment)
---
# Effect of Homocysteine-lowering Therapy With Folic Acid, Vitamin B12, and Vitamin B6 on Endothelium-dependent Vasodilatation of Forearm Resistance Vessels in Patients With Coronary Heart Disease

**NCT ID:** [NCT00693589](https://clinicaltrials.gov/study/NCT00693589)

## Key Facts

- **Status:** COMPLETED
- **Phase:** PHASE2
- **Study Type:** INTERVENTIONAL
- **Target Enrollment:** 36
- **Lead Sponsor:** Insel Gruppe AG, University Hospital Bern
- **Conditions:** Cardiovascular Disease, Endothelial Dysfunction
- **Start Date:** 2005-01
- **Completion Date:** 2007-04
- **CT.gov Last Update:** 2024-11-07

## Brief Summary

Endothelial dysfunction is an early marker of atherosclerosis and is found in patients (pts) with coronary (CAD) and peripheral artery disease (PAD). Statin-therapy has been shown to improve endothelial function in pts with CAD or PAD by reducing LDL-cholesterol and inflammatory markers. B-group vitamin-supplements have variable been reported to have positive or neutral effects on endothelial function. Therefore, we want to compare the effect of rosuvastatin and B-group vitamin supplementation on endothelial function of the forearm resistance vessels in pts with cardiovascular disease.

## Detailed Description

Study design: 36 pts with CAD or PAD are randomly assigned to either rosuvastatin 10mg/d or vitamin supplementation with folic acid 1mg, vitamin B12 0.4mg and B6 10mg/d for 6 weeks in a double-blinded design. After 6 weeks all pts receive rosuvastatin and vitamin supplementation in combination for additional 6 weeks.

## Eligibility

- **Minimum age:** 18 Years
- **Sex:** ALL
- **Healthy Volunteers:** No

```
Inclusion Criteria:

* CAD or PAD (\>50% luminal stenosis), previous myocardial infarction or bypass surgery \>3 month ago
* history of percutaneous coronary intervention (PTCA or stenting)
* confirmed consent

Exclusion Criteria:

* myocardial infarction or acute coronary syndrome or bypass surgery \<3 month ago
* ongoing treatment with statins
* ongoing vitamin supplementation with folic acid and B vitamins
* \<18 years
* active smokers
* uncontrolled arterial hypertension
* renal insufficiency
* atrial fibrillation
* liver disease
* NYHA class \>2
* familial hypercholesterolemia
```

## Arms

- **R** (ACTIVE_COMPARATOR) — Rosuvastatin treatment for 6 weeks and after that combined treatment with rosuvastatin and vitamin supplementation for additional 6 weeks
- **V** (ACTIVE_COMPARATOR) — Vitamin supplementation with folic acid, vitamin B12 and B6 for 6 weeks and after that combined treatment with vitamin supplementation and rosuvastatin

## Interventions

- **folic acid, vitamin B12 and B6 and rosuvastatin** (DRUG) — Vitamin supplementation with folic acid 1mg/d, vitamin B12 0.4mg/d and B6 10mg/d po for 6 weeks alone vs. rosuvastatin 10mg/d for 6 weeks alone and thereafter combined treatment for 6 weeks

## Primary Outcomes

- **Flow mediated dilatation (FMD)** _(time frame: after 6 weeks of randomized treatment and after 6 weeks of combined treatment)_

## Secondary Outcomes

- **changes in biochemistry parameters** _(time frame: after 6 weeks of randomized treatment and after 6 weeks of combined treatment)_

## Recent Field Changes (last 30 days)

- `status.overallStatus` — added _(2026-05-12)_
- `status.primaryCompletionDate` — added _(2026-05-12)_
- `status.completionDate` — added _(2026-05-12)_
- `status.lastUpdatePostDate` — added _(2026-05-12)_
- `design.phases` — added _(2026-05-12)_
- `design.enrollmentCount` — added _(2026-05-12)_
- `eligibility.criteria` — added _(2026-05-12)_
- `eligibility.minAge` — added _(2026-05-12)_
- `eligibility.sex` — added _(2026-05-12)_
- `outcomes.primary` — added _(2026-05-12)_
- `outcomes.secondary` — added _(2026-05-12)_
- `armsInterventions.arms` — added _(2026-05-12)_
- `armsInterventions.interventions` — added _(2026-05-12)_
- `sponsor.lead` — added _(2026-05-12)_
- `results.hasResults` — added _(2026-05-12)_

---

*Canonical: https://parkinsonspathways.com/agent/trials/NCT00693589.md*  
*Source data (authoritative): https://clinicaltrials.gov/study/NCT00693589*  
*This page is a raw mirror with no AI summary, no editorial enrichment, and no Parkinson's-specific filtering.*