---
title: Iron Substitution After Total Knee Arthroplasty
nct_id: NCT01611181
overall_status: COMPLETED
phase: PHASE1
sponsor: Northern Orthopaedic Division, Denmark
study_type: INTERVENTIONAL
primary_condition: Haemodynamic Rebound
countries: Denmark
canonical_url: "https://parkinsonspathways.com/agent/trials/NCT01611181.md"
clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT01611181"
ct_last_update_post_date: 2014-03-31
last_seen_at: "2026-05-12T06:29:50.585Z"
source: ClinicalTrials.gov (mirrored, no enrichment)
---
# Iron Substitution After Total Knee Arthroplasty

**Official Title:** Iron Substitution After Total Knee Arthroplasty - a Randomized Study

**NCT ID:** [NCT01611181](https://clinicaltrials.gov/study/NCT01611181)

## Key Facts

- **Status:** COMPLETED
- **Phase:** PHASE1
- **Study Type:** INTERVENTIONAL
- **Target Enrollment:** 72
- **Lead Sponsor:** Northern Orthopaedic Division, Denmark
- **Collaborators:** Aalborg University
- **Conditions:** Haemodynamic Rebound
- **Start Date:** 2006-05
- **Completion Date:** 2007-06
- **CT.gov Last Update:** 2014-03-31

## 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.

## Detailed Description

Hip and knee arthroplasties are performed with increasing frequency in the western world, and in Denmark approximately 12,000 operations are performed annually (2/1000/year). The perioperative and postoperative blood loss generally constitutes ½ -1½ litres which is frequently associated with symptom-producing anaemia which obstructs mobilisation and increases the risk of complications.

Postoperative iron supplementation for a period of up to 12 weeks is therefore a frequently adopted practice. However, there is no consensus or evidence that support postoperative iron supplementation and the effects of iron deficiency are unclear. It is well-known that iron supplementation causes gastrointestinal adverse effects in up to 25% of cases.

## Eligibility

- **Minimum age:** 18 Years
- **Sex:** ALL
- **Healthy Volunteers:** No

```
Inclusion Criteria:

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

Exclusion Criteria:

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

## Arms

- **Hemoboost (iron supplementation)** (ACTIVE_COMPARATOR) — A registered natural product containing specially haemolysed haemoglobin and iron dextran.
- **Kräuterblut (iron supplementation)** (ACTIVE_COMPARATOR) — A registered natural product made from a number of herbs with ferrous gluconate as the active substance.
- **Ferrofumerat (iron supplementation)** (ACTIVE_COMPARATOR) — Ferrous sulphate

## Interventions

- **Hemoboost** (DRUG) — 200 mg specially processed haemoglobin and 30 mg iron dextran equivalent to 10.5 mg organically bound iron in 1 tablet twice daily.
- **Kräuterblut** (DRUG) — 40 mg iron, 20 ml twice daily.
- **Ferrofumerat** (DRUG) — 200 mg ferrous sulphate as 1 tablet twice daily.

## Primary Outcomes

- **Haemoglobin concentration** _(time frame: 3 months)_ — 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.

## Secondary Outcomes

- **Pain measurement** _(time frame: 3 months)_
- **Consumption af analgesics** _(time frame: 3 months)_
- **Healing of ulcer** _(time frame: 3 months)_
- **Basic need for facilities** _(time frame: 3 months)_
- **Level of activity** _(time frame: 3 months)_

## Locations (1)

- Frederikshavn Hospital, Aalborg Hospital/Aarhus University, Frederikshavn, Denmark

## Recent Field Changes (last 30 days)

- `outcomes.primary` — added _(2026-05-12)_
- `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.minAge` — added _(2026-05-12)_
- `eligibility.sex` — added _(2026-05-12)_
- `outcomes.secondary` — added _(2026-05-12)_
- `armsInterventions.arms` — added _(2026-05-12)_
- `armsInterventions.interventions` — added _(2026-05-12)_
- `sponsor.lead` — added _(2026-05-12)_
- `sponsor.collaborators` — added _(2026-05-12)_
- `results.hasResults` — added _(2026-05-12)_
- `locations.frederikshavn hospital, aalborg hospital/aarhus university|frederikshavn||denmark` — added _(2026-05-12)_

---

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