Introduction  The present study was designed to determine whether women with a proven iron deficiency can be effectively treated with Floradix®. Secondary objectives were to determine the side-effects of taking Floradix®. If Floradix® can effectively increase serum ferritin,then it can be used for the treatment of “prevention of iron deficiency anemia”. In addition, Floradix® could also be used where the treatment indication is lack of iron causing “performance weakness”.
Background
Approximately 40% of women of child bearing years are considered to have low iron status (ferritin 30 µg/L) (Millman 2003). More conservative estimates suggest that 9% - 11% of women of child bearing years are iron deficient,with iron deficiency anemia present in 2% - 5% of this population (Looker 1997).
Only one in five women have iron stores considered adequate for pregnancy (40 µg/L – 70 µg/L) (Millman 2003).Fifty-eight percent of pregnant women have been shown to have iron deficiency at time of delivery (Makrides 2003.)
Pharmacological doses of iron are associated with:
•Reduced patient compliance due to free iron in the intestinal tract causing irritation of the intestinal mucosa;
•Increased free radical damage caused by iron overload;
•Reduced absorption of copper,zinc and molybdenum caused by competitive inhibition.
Low dosage, prolonged iron supplementation could prevent any increase in the risk of cardiovascular disease and a reduction in the promotion of carcinogenic processes (Sullivan 1999).As a result, examining Floradix® (physiological doses of iron embedded in a plant- based food matrix) may prove useful in achieving health outcomes with few risks and side-effect.
Study Design Forty-one women,ages 18 to 65 (mean age 39,95% still menstruating),with documented low ferritin levels and no pre-existing medical conditions were randomized to either a control group (given nutritional advice on how to increase iron-rich foods) or a group which received the same dietary advice plus supplemental Floradix®. For 16 weeks,the treatment group supplemented 10ml three times per day of Floradix® (30ml of Floradix® delivers 30mg of elemental iron as ferrous gluconate in solution).
The study was conducted in 2002 at the Heidelberg Women’s University Clinic,Outpatient Department of Natural Medicine. At baseline, and at weeks 4,8 and 16,all subjects underwent assessment of serum ferritin levels,as well as a complete blood count (CBC). Subjects also completed subjective questionnaires relating to diet recall, adverse effects, and symptoms of fatigue (see table 1).
.Results Floradix demonstrated an ability to rapidly and significantly increase ferritin levels in this population. Over the 16 week study duration, the median ferritin values rose from 13.0 μg/L to 20.0 μg/L in Floradix treated subjects, with no change (median 12.5 μg/L – 13.5 μg/L throughout the 16 week intervention period) in the control group (see figure 1).
Significant increases in serum ferritin were evident after only four
weeks of supplementation in the Floradix group—highlighting that the impact of the intervention occurs quickly.
Baseline red blood cell counts were within the normal range, and did not increase over the 16 week treatment period.
Adverse effect monitoring demonstrated that only 10% of the
subjects reported any concern with the intervention, with mild
gastrointestinal discomfort being the most common complaint.
Patients were asked the question, “How do you feel overall?”, as part of the subjective assessment of the study. “Good” or “very good” responses were obtained from 70% of subjects in the Floradix group and from only 28% of subjects in the control group.
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Floradix demonstrated an ability to rapidly and significantly increase
ferritin levels in this population. Over the 16 week study duration, the
median ferritin values rose from 13.0 μg/L to 20.0 μg/L in Floradix
treated subjects, with no change (median 12.5 μg/L – 13.5 μg/L
throughout the 16 week intervention period) in the control group
(see figure 1).
Significant increases in serum ferritin were evident after only four
weeks of supplementation in the Floradix group—highlighting that
the impact of the intervention occurs quickly.
Baseline red blood cell counts were within the normal range, and did
not increase over the 16 week treatment period.
Adverse effect monitoring demonstrated that only 10% of the
subjects reported any concern with the intervention, with mild
gastrointestinal discomfort being the most common complaint.
Patients were asked the question, “How do you feel overall?”, as part
of the subjective assessment of the study. “Good” or “very good”
responses were obtained from 70% of subjects in the Floradix group
and from only 28% of subjects in the control group.
Figure 1. Comparison of median serum ferritin values in Floradix supplemented versus control subjects over the 16 week treatment period.
Conclusion Floradix is effective for preventing iron deficiency and for treating
low serum ferritin—with minimal side-effects and high compliance
by patients.
Literature cited
Looker, A.C., Dallman, P.R. Carroll, M.D., Gunter, E.W., and Johnson, C.L. 1997.Prevalence of iron deficiency in the United States. JAMA. 277(12):973-6.
Makrides, M., Crowther, C.A., Gibson, R.A., Gibson, R.S., Skeaff, C.M. 2003. Efficacy and tolerability of low-dose iron supplements during pregnancy: a randomized controlled trial. American Journal of Clinical Nutrition. 78(1):145-53.
Millman, N., Byg, K.E., Ovesen, L., Kirchoff, M., Jurgensen, K.S. 2003. Iron status in Danish women, 1984-1994: a cohort comparison of changes in iron stores and the prevalence of iron deficiency and iron overload. European Journal of
Haematology. 71(1):51-61.
Sullivan, J.L. 1999. Iron therapy and cardiovascular disease. Kidney International Supplement. 69(S):135-7.
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