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A Comparative Absorption Study of Various Iron Salts Supplements

Primary Purpose

Iron Deficiency, Iron Deficiency Anemia

Status
Recruiting
Phase
Not Applicable
Locations
Pakistan
Study Type
Interventional
Intervention
Ferrous sulphate
Ferric pyrophosphate
Ferric sodium pyrophosphate
Vitamin D3
Sponsored by
Liaquat University of Medical & Health Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Iron Deficiency

Eligibility Criteria

18 Years - 50 Years (Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Bilawal Medical College HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Active Comparator

Arm Label

Intervention Arm B

Intervention Arm C

Interventional Arm D

Control Arm

Arm Description

Subjects in this arm will receive a daily single dose of oral 30mg elemental iron supplement as Ferrous Sulphate for 6 weeks

Subjects in this arm will receive a daily single dose of oral 30mg elemental iron supplement as Ferric Pyrophosphate for 6 weeks

Subjects in this arm will receive a daily single dose of oral 30mg elemental iron supplement as Ferric Sodium Pyrophosphate for 6 weeks

Subjects in this arm will receive a daily single dose of oral Vitamin D (200 IU) supplement for 6 weeks

Outcomes

Primary Outcome Measures

Change in serum iron concentration
Increase in the circulatory iron levels

Secondary Outcome Measures

Change in Red Blood Cells
Increase in red blood cell counts

Full Information

First Posted
August 2, 2023
Last Updated
August 10, 2023
Sponsor
Liaquat University of Medical & Health Sciences
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1. Study Identification

Unique Protocol Identification Number
NCT05985070
Brief Title
A Comparative Absorption Study of Various Iron Salts Supplements
Official Title
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.
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
July 17, 2023 (Actual)
Primary Completion Date
September 30, 2023 (Anticipated)
Study Completion Date
October 30, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Liaquat University of Medical & Health Sciences

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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
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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Iron Deficiency, Iron Deficiency Anemia

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Intervention Arm B
Arm Type
Experimental
Arm Description
Subjects in this arm will receive a daily single dose of oral 30mg elemental iron supplement as Ferrous Sulphate for 6 weeks
Arm Title
Intervention Arm C
Arm Type
Experimental
Arm Description
Subjects in this arm will receive a daily single dose of oral 30mg elemental iron supplement as Ferric Pyrophosphate for 6 weeks
Arm Title
Interventional Arm D
Arm Type
Experimental
Arm Description
Subjects in this arm will receive a daily single dose of oral 30mg elemental iron supplement as Ferric Sodium Pyrophosphate for 6 weeks
Arm Title
Control Arm
Arm Type
Active Comparator
Arm Description
Subjects in this arm will receive a daily single dose of oral Vitamin D (200 IU) supplement for 6 weeks
Intervention Type
Dietary Supplement
Intervention Name(s)
Ferrous sulphate
Intervention Description
Daily single oral dose of 30 mg
Intervention Type
Dietary Supplement
Intervention Name(s)
Ferric pyrophosphate
Intervention Description
Daily single oral dose of 30 mg
Intervention Type
Dietary Supplement
Intervention Name(s)
Ferric sodium pyrophosphate
Intervention Description
Daily single oral dose of 30 mg
Intervention Type
Dietary Supplement
Intervention Name(s)
Vitamin D3
Intervention Description
Daily single oral dose of 200 IU
Primary Outcome Measure Information:
Title
Change in serum iron concentration
Description
Increase in the circulatory iron levels
Time Frame
6 weeks
Secondary Outcome Measure Information:
Title
Change in Red Blood Cells
Description
Increase in red blood cell counts
Time Frame
6 weeks
Other Pre-specified Outcome Measures:
Title
Number of patients reporting Gastrointestinal side effects
Description
Total number of adverse events in each group
Time Frame
6 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Facility Information:
Facility Name
Bilawal Medical College Hospital
City
Kotri
State/Province
Sindh
ZIP/Postal Code
76000
Country
Pakistan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nazia Mumtaz, M.B.B.S, F.C.P.S
Phone
03453001262
Email
Drnaziahafeez@gmail.com

12. IPD Sharing Statement

Plan to Share IPD
No

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A Comparative Absorption Study of Various Iron Salts Supplements

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