NCT01611181

Brief Summary

Hemoboost is a registered natural product containing specially processed haemolysed haemoglobin and iron dextran. It is marketed for human use on the basis of many years' use and documented effect in veterinary medicine. Iron dextran was introduced for use in human medicine in 1954. Krauterblut is a registered natural product made from a number of herbs where the active substance is ferrous gluconate. Both drugs have been available for a number of years and have become increasingly popular among patients and healthcare staff due to a reduction in adverse effects. The objective of this study is to determine the effect and adverse effects of the natural products Hemoboost and Kräuterblut compared with the usually administered ferrous sulphate in knee arthroplasty.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
72

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started May 2006

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2006

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2006

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2007

Completed
5 years until next milestone

First Submitted

Initial submission to the registry

May 29, 2012

Completed
6 days until next milestone

First Posted

Study publicly available on registry

June 4, 2012

Completed
Last Updated

March 31, 2014

Status Verified

March 1, 2014

Enrollment Period

7 months

First QC Date

May 29, 2012

Last Update Submit

March 28, 2014

Conditions

Haemodynamic Rebound

Keywords

Iron supplementationIron deficiencyHip arthroplastyKnee arthroplasty

Outcome Measures

Primary Outcomes (1)

  • Haemoglobin concentration

    Determine whether peroral iron substitution of Hemo-Boost or Krauterblut results in the same increase of haemoglobin concentration as the usually administered ferrous sulphate. To study the adverse effects of the natural products Hemo-Boost and Krauterblut compared with ferrous sulphate in knee arthroplasty.

    3 months

Secondary Outcomes (5)

  • Pain measurement

    3 months

  • Consumption af analgesics

    3 months

  • Healing of ulcer

    3 months

  • Basic need for facilities

    3 months

  • Level of activity

    3 months

Study Arms (3)

Hemoboost (iron supplementation)

ACTIVE COMPARATOR

A registered natural product containing specially haemolysed haemoglobin and iron dextran.

Drug: Hemoboost

Kräuterblut (iron supplementation)

ACTIVE COMPARATOR

A registered natural product made from a number of herbs with ferrous gluconate as the active substance.

Drug: Kräuterblut

Ferrofumerat (iron supplementation)

ACTIVE COMPARATOR

Ferrous sulphate

Drug: Ferrofumerat

Interventions

HemoboostDRUG

200 mg specially processed haemoglobin and 30 mg iron dextran equivalent to 10.5 mg organically bound iron in 1 tablet twice daily.

Also known as: No other names.
Hemoboost (iron supplementation)
KräuterblutDRUG

40 mg iron, 20 ml twice daily.

Also known as: No other names.
Kräuterblut (iron supplementation)
FerrofumeratDRUG

200 mg ferrous sulphate as 1 tablet twice daily.

Also known as: No other names.
Ferrofumerat (iron supplementation)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • age \> 18 years
  • ASA group I-II

You may not qualify if:

  • malignant disorder
  • chronic renal insufficiency
  • urinary tract infection
  • haemorrhagic diathesis
  • haemoglobin \< 7 mmol/l
  • dementia or mental disorder incompatible with survey participation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Frederikshavn Hospital, Aalborg Hospital/Aarhus University

Frederikshavn, Denmark

Location

MeSH Terms

Conditions

Iron Deficiencies

Condition Hierarchy (Ancestors)

Iron Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Study Officials

  • Sten Rasmussen, M.D.Sci.

    Orthopaedic Division, North Denmark Region, Aalborg University Hospital, Denmark

    PRINCIPAL INVESTIGATOR

  • Søren Lundbye-Christensen, Ph.d.

    Aalborg University

    STUDY CHAIR

  • Mogens B. Joergensen, M.D.

    Orthopaedic Division, North Denmark Region, Aalborg University Hospital, Denmark

    STUDY CHAIR

  • Ole Simonsen, M.D.

    Orthopaedic Division, North Denmark Region, Aalborg University Hospital, Denmark

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 29, 2012

First Posted

June 4, 2012

Study Start

May 1, 2006

Primary Completion

December 1, 2006

Study Completion

June 1, 2007

Last Updated

March 31, 2014

Record last verified: 2014-03

Locations

DK(1)