Trial Review

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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 760 0
Condition category
Condition code
Blood 836 836 0 0
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] 711 0
Treatment: Other
Comparator / control treatment
Control group
Dose comparison

Outcomes
Primary outcome [1] 1073 0
Laboratory changes in serum ferritin and haemoglobin concentrations from baseline to end of treatment.
Timepoint [1] 1073 0
Measured at baseline, week 2, week 4 and end of study.
Secondary outcome [1] 1991 0
Laboratory changes in hematocrit, arterial blood gases, mean corpuscular volume, mean corpuscular haemoglobin, peripheral blood smear, and serum bilirubin.
Timepoint [1] 1991 0
Measured at baseline, week 2, week 4 and end of study.
Secondary outcome [2] 1992 0
Changes in symptoms considered to be traditionally associated with the iron phosphate or potassium chloride celloid pictures.
Timepoint [2] 1992 0
Measured at baseline, week 2, week 4 and end of study.
Secondary outcome [3] 1993 0
Subjective changes in the Iowa Fatigue Scale.
Timepoint [3] 1993 0
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?
No
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
20
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 924 0
Commercial sector/Industry
Name [1] 924 0
Blackmores Ltd
Country [1] 924 0
Australia
Primary sponsor type
Commercial sector/Industry
Name
Blackmores Pty Ltd
Address
Country
Australia
Secondary sponsor category [1] 782 0
None
Name [1] 782 0
none
Address [1] 782 0
Country [1] 782 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 2217 0
Southern Cross University Human Research Ethics Committee and Universty of Queensland Human Research Ethics Committee
Ethics committee address [1] 2217 0
Ethics committee country [1] 2217 0
Australia
Date submitted for ethics approval [1] 2217 0
Approval date [1] 2217 0
Ethics approval number [1] 2217 0

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 36255 0
Address 36255 0
Country 36255 0
Phone 36255 0
Fax 36255 0
Email 36255 0
Contact person for public queries
Name 9900 0
Professor Stephen Myers
Address 9900 0
Australian Centre for Complementary Medicine Education and Research (ACCMER)
PO Box 157
Lismore NSW 2480
Country 9900 0
Australia
Phone 9900 0
+61 2 66203403
Fax 9900 0
+61 2 66203307
Email 9900 0
smyers@scu.edu.au
Contact person for scientific queries
Name 828 0
Dr Joan O'Connor
Address 828 0
Australian Centre for Complementary Medicine Education and Research (ACCMER)
PO Box 157
Lismore NSW 2480
Country 828 0
Australia
Phone 828 0
+61 2 66203649
Fax 828 0
+61 2 66203307
Email 828 0
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

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