NCT01015183

Brief Summary

In this double blinded randomized study we evaluate effect of Zinc sulfate for prevention mucositis due to high dose chemotherapy in the patients undergoing bone marrow transplantation whose received Busulfan and/or Cyclophosphamide. Patients randomized in two groups: intervention and control with balanced block randomization method. Intervention group received Zinc sulfate immediately after start conditioning regimen and continued for two weeks. Control group received placebo at the same manner. Prevalence and severity of mucositis will be compared in two groups.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
60

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Nov 2009

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

November 1, 2009

Completed
16 days until next milestone

First Submitted

Initial submission to the registry

November 17, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 18, 2009

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2010

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2011

Completed
Last Updated

July 26, 2011

Status Verified

July 1, 2011

Enrollment Period

1 year

First QC Date

November 17, 2009

Last Update Submit

July 25, 2011

Conditions

MucositisBone Marrow Transplantation

Keywords

MucositisBone Marrow TransplantationBMTHSCT

Outcome Measures

Primary Outcomes (1)

  • The effect of Zinc Sulfate on prevention of mucositis in patients undergoing bone marrow transplantation

    1 year

Secondary Outcomes (2)

  • Evaluation of Zinc Sulfate concentration

    1 year

  • Evaluation of Zinc Sulfate advance effects

    1 year

Study Arms (2)

Intervention

EXPERIMENTAL

Received Zinc Sulfate

Drug: Zinc Sulfate

Control

PLACEBO COMPARATOR

Control group

Drug: Placebo

Interventions

Zinc SulfateDRUG

Zinc Sulfate: 100 mg of zinc element, per day, bid for two weeks start with chemotherapy

Intervention
PlaceboDRUG

Placebo: as the same of intervention group

Control

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Patient undergoing bone marrow transplantation
  • Signed informed consent

You may not qualify if:

  • Unable take drug (or placebo) orally

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hematology-Oncology & SCT Research Center

Tehran, Tehran Province, 14114, Iran

Location

MeSH Terms

Conditions

Mucositis

Interventions

Zinc Sulfate

Condition Hierarchy (Ancestors)

GastroenteritisGastrointestinal DiseasesDigestive System DiseasesMouth DiseasesStomatognathic Diseases

Intervention Hierarchy (Ancestors)

SulfatesSulfuric AcidsSulfur AcidsSulfur CompoundsInorganic ChemicalsZinc Compounds

Study Officials

  • Molouk Hadjibabaie, PhD

    Hematology-Oncology and SCT Research Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

November 17, 2009

First Posted

November 18, 2009

Study Start

November 1, 2009

Primary Completion

November 1, 2010

Study Completion

June 1, 2011

Last Updated

July 26, 2011

Record last verified: 2011-07

Locations

IR(1)