NCT00730509

Brief Summary

The purpose of this study is to determine whether 5 - methyltetrahydrofolate and vitamin B12 supplementation can ameliorate cell plasma membrane features in pediatric patients with cystic fibrosis

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
31

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Apr 2004

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2004

Completed
1.9 years until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2006

Completed
2.4 years until next milestone

First Submitted

Initial submission to the registry

August 4, 2008

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 8, 2008

Completed
Last Updated

August 8, 2008

Status Verified

May 1, 2008

First QC Date

August 4, 2008

Last Update Submit

August 4, 2008

Conditions

Cystic Fibrosis

Keywords

cystic fibrosisfolatevitamin B12

Outcome Measures

Primary Outcomes (1)

  • We evaluated membrane protein oxidative damage of red cells

    6 months

Secondary Outcomes (1)

  • we evaluated cation transport pathways of red cells

    6 months

Interventions

5-methyltetrahydrofolate and vitamin B12DIETARY_SUPPLEMENT

children with cystic fibrosis were supplementated for 6 months with 5-MTHF, 7,5 mg/day ; vitamin B12, 0,5 mg/day

Eligibility Criteria

Age3 Years - 8 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • cystic fibrosis

You may not qualify if:

  • diabetes
  • chronic infections of the airways
  • regular antibiotics intake

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Verona University

Verona, 37134, Italy

Location

Related Publications (2)

  • Scambi C, Guarini P, De Franceschi L, Bambara LM. Can 5-methyltetrahydrofolate modify the phospholipid fatty acid pattern in cystic fibrosis pediatric patients? J Cyst Fibros. 2006 Aug;5(3):197-9. doi: 10.1016/j.jcf.2006.01.006. Epub 2006 Mar 3.

    PMID: 16516563BACKGROUND

  • Scambi C, De Franceschi L, Guarini P, Poli F, Siciliano A, Pattini P, Biondani A, La Verde V, Bortolami O, Turrini F, Carta F, D'Orazio C, Assael BM, Faccini G, Bambara LM. Preliminary evidence for cell membrane amelioration in children with cystic fibrosis by 5-MTHF and vitamin B12 supplementation: a single arm trial. PLoS One. 2009;4(3):e4782. doi: 10.1371/journal.pone.0004782. Epub 2009 Mar 11.

    PMID: 19277125DERIVED

MeSH Terms

Conditions

Cystic Fibrosis

Interventions

5-methyltetrahydrofolateVitamin B 12

Condition Hierarchy (Ancestors)

Pancreatic DiseasesDigestive System DiseasesLung DiseasesRespiratory Tract DiseasesGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesInfant, Newborn, Diseases

Intervention Hierarchy (Ancestors)

CorrinoidsTetrapyrrolesPyrrolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsHeterocyclic Compounds, 4 or More RingsHeterocyclic Compounds, Fused-RingMacrocyclic CompoundsPolycyclic Compounds

Study Officials

  • Lisa M. Bambara, MD

    Verona University

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

August 4, 2008

First Posted

August 8, 2008

Study Start

April 1, 2004

Study Completion

March 1, 2006

Last Updated

August 8, 2008

Record last verified: 2008-05

Locations

IT(1)