---
title: Does B Vitamin Supplementation Decrease Homocysteine Concentrations in Newborns
nct_id: NCT00877227
overall_status: COMPLETED
phase: PHASE1
sponsor: Radboud University Medical Center
study_type: INTERVENTIONAL
primary_condition: Mild Hyperhomocysteinemia
countries: Netherlands
canonical_url: "https://parkinsonspathways.com/agent/trials/NCT00877227.md"
clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT00877227"
ct_last_update_post_date: 2009-05-06
last_seen_at: "2026-05-12T07:02:47.185Z"
source: ClinicalTrials.gov (mirrored, no enrichment)
---
# Does B Vitamin Supplementation Decrease Homocysteine Concentrations in Newborns

**Official Title:** Does Folinic Acid Supplementation Decrease Homocysteine Concentrations in Newborns

**NCT ID:** [NCT00877227](https://clinicaltrials.gov/study/NCT00877227)

## Key Facts

- **Status:** COMPLETED
- **Phase:** PHASE1
- **Study Type:** INTERVENTIONAL
- **Target Enrollment:** 37
- **Lead Sponsor:** Radboud University Medical Center
- **Conditions:** Mild Hyperhomocysteinemia
- **Start Date:** 2003-01
- **Completion Date:** 2003-11
- **CT.gov Last Update:** 2009-05-06

## Brief Summary

The purpose of this study is to determine whether supplementation with folinic acid, a B vitamin, lowers the concentrations of total homocysteine in newborns. Increased homocysteine concentrations are associated with an increased risk of cerebrovascular accidents in adult, children and newborns. These increased concentrations can easily and safely be lowered by folic acid in adults.

## Detailed Description

The incidence of cerebrovascular accidents (CVA) occurring perinatally is relatively high and aspects of the multifactorial pathophysiology remain unclear. Elevated homocysteine concentrations are shown to be associated with an increased risk for CVA in newborns. We want to study the possible homocysteine lowering effect of folinic acid in newborns.

We will include newborns in our prospective randomized folinic acid intervention study from patients admitted to our Neonatal Intensive Care Unit. We will measure total homocysteine (tHcy) and folate concentrations at three time points. The intervention group will be treated with folinic acid (70 µg/kg/day) for two weeks.

## Eligibility

- **Maximum age:** 2 Weeks
- **Sex:** ALL
- **Healthy Volunteers:** Yes

```
Inclusion Criteria:

* admitted at our NICU

Exclusion Criteria:

* midline defects
* Extracorporeal membrane oxygenation (ECMO) treatment
* blood transfusion
* overt renal failure
```

## Arms

- **folinic acid** (EXPERIMENTAL) — Folinic acid was given for two weeks as 5-formyltetrahydrofolate (10 mg/ml) (Pharmachemie bv). This solution was administered either intravenously (first week) or orally. To lower homocysteine in adults 5 mg/day folic acid is frequently used. Using an average bodyweight of 70 kg for adults we calculated a daily dose of 70 microgram/kg/day for our newborns
- **2** (NO_INTERVENTION) — control subjects admitted at the Neonatal Intensive Care Unit (NICU)

## Interventions

- **5-formyltetrahydrofolate (10 mg/ml) (Pharmachemie bv)** (DRUG) — Folinic acid was given for two weeks as 5-formyltetrahydrofolate (10 mg/ml) (Pharmachemie bv). This solution was administered either intravenously (first week) or orally. To lower homocysteine in adults 5 mg/day folic acid is frequently used. Using an average bodyweight of 70 kg for adults we calculated a daily dose of 70 microgram/kg/day for our newborns.

## Primary Outcomes

- **lowering total homocysteine concentrations** _(time frame: 2 weeks)_

## Locations (1)

- Radboud University Medical center Nijmegen, Nijmegen, Netherlands

## 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.maxAge` — added _(2026-05-12)_
- `eligibility.sex` — added _(2026-05-12)_
- `outcomes.primary` — 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)_
- `locations.radboud university medical center nijmegen|nijmegen||netherlands` — added _(2026-05-12)_

---

*Canonical: https://parkinsonspathways.com/agent/trials/NCT00877227.md*  
*Source data (authoritative): https://clinicaltrials.gov/study/NCT00877227*  
*This page is a raw mirror with no AI summary, no editorial enrichment, and no Parkinson's-specific filtering.*