NCT04329286

Brief Summary

Iron demand: The average daily demand to fit the cell biological metabolism is balanced between intake and lost which about 1-2 mg.

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Apr 2020

Typical duration for all trials

Status
unknown

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

First Submitted

Initial submission to the registry

March 29, 2020

Completed
3 days until next milestone

First Posted

Study publicly available on registry

April 1, 2020

Completed
Same day until next milestone

Study Start

First participant enrolled

April 1, 2020

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2021

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2022

Completed
Last Updated

April 1, 2020

Status Verified

March 1, 2020

Enrollment Period

1.1 years

First QC Date

March 29, 2020

Last Update Submit

March 29, 2020

Conditions

Outcome Measures

Primary Outcomes (1)

  • Platelet Changes in Cases of Iron Overload(IO)

    Platelet Changes in Cases of Iron Overload(IO)

    1year

Eligibility Criteria

Age1 Month - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Platelet Changes in Cases of Iron Overload(IO)

You may qualify if:

  • Patients around age of 6 to 18 years
  • Patients with thalassemia disease

You may not qualify if:

  • \- Patients less than 6 years and more than 18 years.
  • Patients with sever inflammatory disease.
  • Patients with any malignant disease.
  • Patients take steroid or bone marrow suppression drugs.
  • Patients with aplastic anemia or pancytopenia.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (4)

  • Hoffbrand AV, Taher A, Cappellini MD. How I treat transfusional iron overload. Blood. 2012 Nov 1;120(18):3657-69. doi: 10.1182/blood-2012-05-370098. Epub 2012 Aug 23.

    PMID: 22919029BACKGROUND
  • Vlasic N, Medow MS, Schwarz SM, Pritchard KA Jr, Stemerman MB. Lipid fluidity modulates platelet aggregation and agglutination in vitro. Life Sci. 1993;53(13):1053-60. doi: 10.1016/0024-3205(93)90258-5.

    PMID: 8366768BACKGROUND
  • Wachowicz B, Olas B, Zbikowska HM, Buczynski A. Generation of reactive oxygen species in blood platelets. Platelets. 2002 May;13(3):175-82. doi: 10.1080/09533710022149395.

    PMID: 12180500BACKGROUND
  • Cikrikcioglu MA, Celik K, Ekinci I, Nasifov M, Toprak AE, Cetin G, Genc S. Mean Platelet Volume in Heterozygous Beta Thalassaemia. Acta Haematol. 2017;137(2):100-105. doi: 10.1159/000455813. Epub 2017 Feb 17.

    PMID: 28208125BACKGROUND

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
principal investigator

Study Record Dates

First Submitted

March 29, 2020

First Posted

April 1, 2020

Study Start

April 1, 2020

Primary Completion

May 1, 2021

Study Completion

May 1, 2022

Last Updated

April 1, 2020

Record last verified: 2020-03