A Comparative Absorption Study of Various Iron Salts Supplements

Study Overview
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Brief Summary
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This study is conducted on otherwise healthy individuals presenting with symptoms of iron deficiency anemia, further confirmed by CBC and Iron Profile. The expected outcome is overall improvement after taking oral iron supplements and is aimed to compare the efficacy and tolerability of different oral iron supplements by analyzing the changes in red cell parameters and serum iron concentration in anemic and healthy population in parallel, at a given time period.

Detailed Description
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Iron deficiency is commonest cause of anemia in developing countries like Pakistan. Multiple determinants of iron deficiency anemia have been identified in the literature including genetic and environmental factors. The predominant factors are lack of proper diet, poor socioeconomic status, high parity of women, access to poor health. Symptomatic anemic cases are often treated with blood transfusion and thereby increasing burden on already resource restricted healthcare system. In order to emphasize the importance of iron supplements this Randomized controlled trial is conducted to assess the efficacy of three different oral iron supplements formulated with different salts. Oral iron follows an extensive route of absorption which is primarily performed through enterocyte cells on the duodenum and upper jejunum of the small intestine, interacting with dietary inhibitors such as calcium, phytates, polyphenols and enhancers such as ascorbic acid and proteins which may influence its bioavailability. Three Different iron salts supplements; 1. Ferrous Sulphate, 2. Ferric pyrophosphate and 3. Ferric sodium pyrophosphate, are analyzed for their efficiency and tolerability when taken on empty stomach daily single oral dose of 30 mg, for up to 6 weeks. There is a parallel healthy control group, given a non-iron supplement. The changes in Red blood cell parameters and serum iron levels are analyzed, at 5 different times starting from baseline before giving first dose of supplements, Reading 1 (baseline), Reading 2 (3 hours) , Reading 3 (6 hours), Reading 4 (24 hours) and Reading 5 (6 weeks). The expected outcomes are: Proportion of the subjects achieving the normal Hb levels Improvement in serum iron levels Improvement in ferritin levels

Official Title
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A Comparative Efficacy and Tolerability Study of Oral Iron Treatment in Healthy Iron Deficient and/or Iron-deficient Anaemic Adults: A Perspective, Randomized, Parallel Group, and Controlled Clinical Trial.

Conditions
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Iron Deficiency, Iron Deficiency Anemia

Intervention / Treatment
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* Dietary Supplement: Ferrous sulphate
* Dietary Supplement: Ferric pyrophosphate
* Dietary Supplement: Ferric sodium pyrophosphate
* Dietary Supplement: Vitamin D3


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Outpatients Age: 18 - 45 years, both gender Haemoglobin level < 12 g/dL Serum ferritin levels < 30 µg/L. Transferrin Saturation (TSAT) < 20 % Able to provide informed written consent. Able to adhere to the study protocol and willing to cooperate with the study investigators. Exclusion Criteria: Other causes of anaemia, apart from iron deficiency. Pregnant or lactating women, or women intending to become pregnant during the study. Administration of any iron-containing drugs during the last 3 months. History of erythropoietin drugs administration. People with cancer, chronic liver disease, chronic kidney disease, HIV, cardiovascular disease, pulmonary disease, mental health disorder, inflammatory disease such as IBD, any GI disease or disorder likely to affect the nutritional intestinal absorption. Subjects on Antacids (aluminium, calcium, magnesium preparations), anti-inflammatory drugs (NSAIDs, salicylates), antibiotic medications (aminoglycosides), cholesterol lowering medication (Bile acid-sequestrants), Ulcer medication (histamine H2 Antagonists), PPIs etc. Concomitant diseases and conditions, which, in the investigator's opinion, pose risk to a subject's safety in case of his/her participation in the study, or able to affect the safety data analysis in case of exacerbation of this disease/condition during the study. Hypersensitivity to iron therapy (both Oral and/or IV administration) and other components of the study drugs. Hormone therapy (including the use of androgens/anabolic steroids) or administration of drugs that inhibit blood formation, less than 3 months before the start of the study. History of severe allergic reactions or drug intolerance. Blood donation / blood transfusion within 30 days prior to screening or planned blood transfusion at time of screening.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention Arm B<br>Subjects in this arm will receive a daily single dose of oral 30mg elemental iron supplement as Ferrous Sulphate for 6 weeks | Dietary Supplement: Ferrous sulphate<br>* Daily single oral dose of 30 mg<br>|
| Experimental: Intervention Arm C<br>Subjects in this arm will receive a daily single dose of oral 30mg elemental iron supplement as Ferric Pyrophosphate for 6 weeks | Dietary Supplement: Ferric pyrophosphate<br>* Daily single oral dose of 30 mg<br>|
| Experimental: Interventional Arm D<br>Subjects in this arm will receive a daily single dose of oral 30mg elemental iron supplement as Ferric Sodium Pyrophosphate for 6 weeks | Dietary Supplement: Ferric sodium pyrophosphate<br>* Daily single oral dose of 30 mg<br>|
| Active Comparator: Control Arm<br>Subjects in this arm will receive a daily single dose of oral Vitamin D (200 IU) supplement for 6 weeks | Dietary Supplement: Vitamin D3<br>* Daily single oral dose of 200 IU<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in serum iron concentration | Increase in the circulatory iron levels | 6 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Red Blood Cells | Increase in red blood cell counts | 6 weeks |