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NCT Number: NCT03894449

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

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.

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Key information

Conditions

Iron-deficiency Anemia Anemia, Hypochromic Anemia, Iron-Deficiency Hematologic Diseases Hemic and Lymphatic Diseases Iron Deficiencies Iron Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year–25 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

University of Veterinary and Animal Sciences

Lahore, Punjab Province, 54000, Pakistan

About this study

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).

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Prebiotic + Iron Forificant

Combination Product

A combination dosage of prebiotic (Inulin or GOS) and Iron Fortificant (FeSO4 or NaFeEDTA) will be given to the study subjects.

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

University of Veterinary and Animal Sciences, Lahore - Pakistan

Other

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
Mar 28, 2019
Registry last updated
Aug 22, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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