ANZCTR - Registration

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Trial registered on ANZCTR

Registration number

ACTRN12605000632695

Ethics application status

Approved

Date submitted

11/10/2005

Date registered

13/10/2005

Date last updated

21/09/2011

Type of registration

Prospectively registered

Titles & IDs

Public title

The safety and efficacy of two celloid iron supplements in young women with mild anaemia.

Scientific title

The safety and efficacy of two celloid iron supplements in young women with mild anaemia comparing baseline serum ferritin and haemoglobin concentrations with post-treatment levels over a 4-week treatment period.

Universal Trial Number (UTN)

Trial acronym

none

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Mild anemia

Condition category

Condition code

Blood

Anaemia

Intervention/exposure

Study type

Interventional

Description of intervention(s) / exposure

Two celloid iron supplements taken over a 4 week treatment period.

Intervention code [1]

Treatment: Other

Comparator / control treatment

Control group

Dose comparison

Outcomes

Primary outcome [1]

Laboratory changes in serum ferritin and haemoglobin concentrations from baseline to end of treatment.

Timepoint [1]

Measured at baseline, week 2, week 4 and end of study.

Secondary outcome [1]

Laboratory changes in hematocrit, arterial blood gases, mean corpuscular volume, mean corpuscular haemoglobin, peripheral blood smear, and serum bilirubin.

Timepoint [1]

Measured at baseline, week 2, week 4 and end of study.

Secondary outcome [2]

Changes in symptoms considered to be traditionally associated with the iron phosphate or potassium chloride celloid pictures.

Timepoint [2]

Measured at baseline, week 2, week 4 and end of study.

Secondary outcome [3]

Subjective changes in the Iowa Fatigue Scale.

Timepoint [3]

Measured at baseline, week 2, week 4 and end of study.

Eligibility

Key inclusion criteria

Good general health. Haemoglobin levels 10-12g/dl. Serum ferritin <20mg/L. Non-smoker.

Minimum age

18 Years

Maximum age

25 Years

Sex

Females

Can healthy volunteers participate?

Key exclusion criteria

Use of iron supplements 4 weeks before recruitment Liver function enzymes >3 times the upper limit of normal at baseline Hemochromatosis Polycythemia Sickle cell anaemia Gastro intestinal disorders Heart disease Taking oral anticoagulants Past allergic responses to iron supplementation Pregnancy or breast feeding Menorrhagia Consumption of more than 14 standard alcoholic drinks per week Conditions that compromise digestion or absorption of iron Taking antibiotics Taking zinc supplements Individuals who have had a gastrectomy Peptic or gastric ulcer Renal disease Affective disorders Subjects unwilling to comply with study protocol Poor venous access Any other condition, which in the opinion of the investigators could compromise the study.

Study design

Purpose of the study

Treatment

Allocation to intervention

Randomised controlled trial

Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)

Subjects will randomised according to heamoglobin levels, the tablets will be labelled by an independant researcher who will retain the allocation schedule until the end of the trial in a sealed envelope.

Methods used to generate the sequence in which subjects will be randomised (sequence generation)

computer programme will generate randomisation

Masking / blinding

Blinded (masking used)

Who is / are masked / blinded?

Intervention assignment

Parallel

Other design features

Phase

Phase 3

Type of endpoint/s

Safety/efficacy

Statistical methods / analysis

Recruitment

Recruitment status

Not yet recruiting

Date of first participant enrolment

Anticipated

23/03/2006

Actual

Date of last participant enrolment

Anticipated

Actual

Date of last data collection

Anticipated

Actual

Sample size

Target

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

Funding & Sponsors

Funding source category [1]

Commercial sector/Industry

Name [1]

Blackmores Ltd

Address [1]

Country [1]

Australia

Primary sponsor type

Commercial sector/Industry

Name

Blackmores Pty Ltd

Address

Country

Australia

Secondary sponsor category [1]

None

Name [1]

none

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Southern Cross University Human Research Ethics Committee and Universty of Queensland Human Research Ethics Committee

Ethics committee address [1]

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

Approval date [1]

Ethics approval number [1]

Summary

Brief summary

Anaemia may be defined as a decrease in haemoglobin to levels below recognised normal laboratory ranges, resulting in diminished delivery of oxygen to the tissues.  Symptoms of anaemia are related to reduced oxygenation and depending on severity includes dizziness, fatigue, exertional dyspnoea, headache, insomnia and pallor.  Causation is associated with either reduced production of red cells, increased destruction of red cells or loss of blood and may result from hereditary factors, or nutritional deficits such as iron deficiency, vitamin B12 or folate deficiency or generalised malnutrition.  Physical factors include the intake of certain drugs or chemicals, trauma, haemorrhage or chronic illness.  Anaemia is classified morphologically by the haemoglobin content of the red blood cells and by differences in red blood cell size.

Patterson et al. (2001) indicate that women are at greatest risk for iron deficiency due to the effects of menstruation and childbearing.  They cite data that suggests 1 in 3 women have been diagnosed with iron deficiency by the time they reach 45-50.  The World Health Organization's criterion for anaemia in women is haemoglobin values less than 12 g/dL.  
Iron is a micronutrient required in the formation of haemoglobin as well as some of the cytochromes and myoglobin which have a similar haem portion to haemoglobin.  Iron is an essential component of the haemoglobin molecule as it is necessary for the formation of haem, which is the structure to which oxygen binds for transport to the cells.  In the absence of iron, the amount of haemoglobin per red blood cell is reduced and small erythrocytes form.
Celloid Mineral Therapy was developed by an Australian naturopath (Maurice Blackmore) in the 1930s, when he formulated this simple treatment system using the minerals that make up the fundamental structure of the body and are present in food. He based his investigations on the work of Schuessler and Hahnemann who had firmly established the importance of the mineral salts to human health many years earlier.  He found that even a small deficiency of only one of these mineral elements could create or allow a defect in the structure and function of the cell.  Contemporary research has confirmed his focus on minerals as an essential component of cellular health, and their contribution to the structure and function of the human body.  Blackmores Celloid minerals are generally prescribed by qualified practitioners (Herbalists and Naturopaths).  
Study treatments
Iron phosphate 
This is a celloid material that has traditionally been found to have a role in the inflammatory process by enhancing the utilisation of oxygen in order to break down the pathogenic wastes within the body, which allows for enhanced elimination.  It also acts within the muscles and circulatory system by increasing oxygen supply to the muscles and promoting tissue repair within the muscles.  It has a primary function in red cell production and has been found to have a role in iron deficiency anaemia and the symptoms associated with iron deficiency.   Iron phosphate has a tonic action on under active endocrine glands and can improve libido.  

Potassium chloride 
Is also a celloid mineral with an anti-infective and anti-inflammatory action, when used in combination with iron phosphate.  It has traditional beneficial effects within the digestive system, by increasing digestion, promoting both the flow of pancreatic enzymes and bile production.  It reduces fluid retention by alleviating lymphatic congestion.  It promotes blood flow by decreasing blood viscosity resulting in the prevention and removal of fibrous build up and atheromatous plaque formation.  It is recommended by practitioners as being an important treatment in assisting in promoting blood flow by decreasing blood viscosity(10)

Trial website

Trial related presentations / publications

Public notes

Contacts

Principal investigator

Name

Address

Country

Phone

Fax

Contact person for public queries

Name

Professor Stephen Myers

Address

Australian Centre for Complementary Medicine Education and Research (ACCMER)
PO Box 157
Lismore NSW 2480

Country

Australia

Phone

+61 2 66203403

Fax

+61 2 66203307

smyers@scu.edu.au

Contact person for scientific queries

Name

Dr Joan O'Connor

Address

Australian Centre for Complementary Medicine Education and Research (ACCMER)
PO Box 157
Lismore NSW 2480

Country

Australia

Phone

+61 2 66203649

Fax

+61 2 66203307

joconnor@scu.edu.au

No information has been provided regarding IPD availability

What supporting documents are/will be available?

No Supporting Document Provided

Results publications and other study-related documents

Documents added manually

No documents have been uploaded by study researchers.

Documents added automatically

No additional documents have been identified.

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