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Probing the Synergistic Effect of Pre-Biotics & Iron Fortificants in Anemic Subjects

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ClinicalTrials.gov Identifier: NCT03894449
Recruitment Status : Completed
First Posted : March 28, 2019
Results First Posted : August 22, 2019
Last Update Posted : August 22, 2019
Sponsor:
Information provided by (Responsible Party):
ABDUL MOMIN RIZWAN AHMAD, University of Veterinary and Animal Sciences, Lahore - Pakistan

Brief Summary:

Hypothesis: Synergistic effect of pre-biotics and iron fortificants will enhance the bioavailability of iron; thereby improving the body iron reserves.

A double blind, randomized controlled trail will be conducted on iron deficient female adults (age 18-25 years) in order to determine the synergistic effect of pre-biotics and iron fortificants in anemic human subjects. 75 iron deficient females will be randomly divided into 5 groups (D0, D1, D2, D3 and D4), each having 15 study subjects and will be given varying doses of FeSO4 and NaFeEDTA and Inulin and GOS. Blood samples will be collected from overnight fasted women from each group on monthly basis up to three months. Various biomarkers for iron absorption, LFTs, RFTs, and Immunoglobulins will be estimated.


Condition or disease Intervention/treatment Phase
Iron-deficiency Combination Product: Prebiotic + Iron Forificant Phase 1 Phase 2

Detailed Description:

Study Design A double blind, randomized controlled trial will be used for the purpose of this study.

Study Site The study will be conducted in Islamabad and/or Lahore, depending on the availability of the required sample size with the desired profiles.

Study Duration The trial will last for 12 weeks. Study Population The study population will consist of university going iron deficient female adults (age 18-25 years).

Inclusion and Exclusion Criteria Inclusion Criteria All willing anemic female adults without any chronic diseases such as diabetes or hypertension will be included in the study.

Exclusion Criteria Married females or those with chronic diseases or those already taking iron and/or prebiotic supplements will be excluded from the study.

Sampling Sampling Technique The technique of convenience sampling will be used for the current study. Sample Size Each group will consist of 15 study subjects for the purpose of convenience and the total sample size will be 75.

Treatment Plan For this phase of the study, 4 best treatment combinations of pre-biotics (Inulin & Galactooligosaccharides) and iron fortificants (FeSO4 and NaFeEDTA) will be chosen.

Study participants will be randomly chosen to receive either the best treatment combination 1, 2, 3, 4 or the placebo for 12 weeks on daily basis.

Efficacy Trials Blood samples will be collected from overnight fasted women from each group on monthly basis up to three months. Hematological analysis The collected blood from respective groups will be assessed for hematological analysis.

Iron Biomarkers Obtained sera will also be analyzed for blood serum biomarkers like serum iron, folate, ferritin, transferrin saturation fraction & TIBC.

Liver function tests Liver function tests including AST (Aspartate Aminotransferase), ALT (Alanine Aminotransferase), ALP (Alkaline Phosphatase) and Total Bilirubin will be conducted Renal function tests Blood urea (GLDH-method) and creatinine (Jaffe-method) levels will be determined using commercial kits.

Immunoglobulins Immunoglobulins, including Immunoglobulin A, Immunoglobulin E, Immunoglobulin G, and Immunoglobulin M will be determined using the technique of ELISA (Enzyme linked Immunosorbent Assay).


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 75 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Probing the Synergistic Effect of Pre-Biotics & Iron Fortificants in Anemic
Actual Study Start Date : April 6, 2019
Actual Primary Completion Date : July 6, 2019
Actual Study Completion Date : July 6, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Iron

Arm Intervention/treatment
Placebo Comparator: Placebo only Combination Product: Prebiotic + Iron Forificant
A combination dosage of prebiotic (Inulin or GOS) and Iron Fortificant (FeSO4 or NaFeEDTA) will be given to the study subjects.

Experimental: Prebiotic Inulin & Iron Salt FeSO4 Combination Product: Prebiotic + Iron Forificant
A combination dosage of prebiotic (Inulin or GOS) and Iron Fortificant (FeSO4 or NaFeEDTA) will be given to the study subjects.

Experimental: Prebiotic GOS & Iron Salt FeSO4 Combination Product: Prebiotic + Iron Forificant
A combination dosage of prebiotic (Inulin or GOS) and Iron Fortificant (FeSO4 or NaFeEDTA) will be given to the study subjects.

Experimental: Prebiotic Inulin & Iron Salt NaFeEDTA Combination Product: Prebiotic + Iron Forificant
A combination dosage of prebiotic (Inulin or GOS) and Iron Fortificant (FeSO4 or NaFeEDTA) will be given to the study subjects.

Experimental: Prebiotic GOS & Iron Salt NaFeEDTA Combination Product: Prebiotic + Iron Forificant
A combination dosage of prebiotic (Inulin or GOS) and Iron Fortificant (FeSO4 or NaFeEDTA) will be given to the study subjects.




Primary Outcome Measures :
  1. Change in Hemoglobin Concentration From Baseline to 90 Days [ Time Frame: Baseline, 30 days, 60 days, 90 days ]
  2. Change in Hematocrit in Concentration From Baseline to 90 Days [ Time Frame: Baseline, 30 days, 60 days, 90 days ]
  3. Change in Mean Corpuscular Volume From Baseline to 90 Days [ Time Frame: Baseline, 30 days, 60 days, 90 days ]
  4. Change in Mean Corpuscular Hemoglobin From Baseline to 90 Days [ Time Frame: Baseline, 30 days, 60 days, 90 days ]
  5. Change in Mean Corpuscular Hemoglobin Concentration From Baseline to 90 Days [ Time Frame: Baseline, 30 days, 60 days, 90 days ]
  6. Change in Serum Iron Levels From Baseline to 90 Days [ Time Frame: Baseline, 30 days, 60 days, 90 days ]
  7. Change in Serum Folate Levels From Baseline to 90 Days [ Time Frame: Baseline, 30 days, 60 days, 90 days ]
  8. Change in Serum Ferritin Levels From Baseline to 90 Days [ Time Frame: Baseline, 30 days, 60 days, 90 days ]
  9. Change in Serum Transferrin Levels From Baseline to 90 Days [ Time Frame: Baseline, 30 days, 60 days, 90 days ]
  10. Change in Transferrin Saturation Factor Levels From Baseline to 90 Days [ Time Frame: Baseline, 30 days, 60 days, 90 days ]
  11. Change in Total Iron Binding Capacity Levels From Baseline to 90 Days [ Time Frame: Baseline, 30 days, 60 days, 90 days ]

Secondary Outcome Measures :
  1. Change in Liver Functions Tests (ALT) From Baseline to 90 Days [ Time Frame: Baseline, 30 days, 60 days, 90 days ]
  2. Change in Liver Functions Tests (AST) From Baseline to 90 Days [ Time Frame: Baseline, 30 days, 60 days, 90 days ]
  3. Change in Liver Functions Tests (ALP) From Baseline to 90 Days [ Time Frame: Baseline, 30 days, 60 days, 90 days ]
  4. Change in Liver Functions Tests (Total Bilirubin) From Baseline to 90 Days [ Time Frame: Baseline, 30 days, 60 days, 90 days ]
  5. Change in Renal Functions Tests (Serum Urea) From Baseline to 90 Days [ Time Frame: Baseline, 30 days, 60 days, 90 days ]
  6. Change in Renal Functions Tests (Serum Creatinine) From Baseline to 90 Days [ Time Frame: Baseline, 30 days, 60 days, 90 days ]
  7. Change in Immunoglobulins (IgA) From Baseline to 90 Days [ Time Frame: Baseline, 30 days, 60 days, 90 days ]
  8. Change in Immunoglobulins (IgE) From Baseline to 90 Days [ Time Frame: Baseline, 30 days, 60 days, 90 days ]
  9. Change in Immunoglobulins (IgG) From Baseline to 90 Days [ Time Frame: Baseline, 30 days, 60 days, 90 days ]
  10. Change in Immunoglobulins (IgM) From Baseline to 90 Days [ Time Frame: Baseline, 30 days, 60 days, 90 days ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 25 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • All willing anemic female adults without any chronic diseases such as diabetes or hypertension will be included in the study.

Exclusion Criteria:

  • Married females or those with chronic diseases or those already taking iron and/or prebiotic supplements will be excluded from the study.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03894449


Locations
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Pakistan
University of Veterinary and Animal Sciences
Lahore, Punjab, Pakistan, 54000
Sponsors and Collaborators
University of Veterinary and Animal Sciences, Lahore - Pakistan
Investigators
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Study Director: Dr. Waqas Ahmad, PhD University of Veterinary & Animal Sciences, Lahore, Pakistan
  Study Documents (Full-Text)

Documents provided by ABDUL MOMIN RIZWAN AHMAD, University of Veterinary and Animal Sciences, Lahore - Pakistan:
Informed Consent Form  [PDF] January 26, 2019


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Responsible Party: ABDUL MOMIN RIZWAN AHMAD, Principal Investigator, University of Veterinary and Animal Sciences, Lahore - Pakistan
ClinicalTrials.gov Identifier: NCT03894449     History of Changes
Other Study ID Numbers: 2015-VA-04
First Posted: March 28, 2019    Key Record Dates
Results First Posted: August 22, 2019
Last Update Posted: August 22, 2019
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: We will see what and how much data will we able to ethically share later on.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Anemia, Iron-Deficiency
Anemia, Hypochromic
Anemia
Hematologic Diseases
Iron Metabolism Disorders
Metabolic Diseases
Iron
Fe(III)-EDTA
Trace Elements
Micronutrients
Nutrients
Growth Substances
Physiological Effects of Drugs
Iron Chelating Agents
Chelating Agents
Sequestering Agents
Molecular Mechanisms of Pharmacological Action