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

Iron-deficiency Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03894449
• Other study ID #: 2015-VA-04
• Status: Completed
• Phase: Phase 1/Phase 2
• Start date: April 6, 2019
• Est. completion date: July 6, 2019

Study information

• Verified date: August 2019
• Source: University of Veterinary and Animal Sciences, Lahore - Pakistan
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 75
• Est. completion date: July 6, 2019
• Est. primary completion date: July 6, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 25 Years

Eligibility

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.

Related Conditions & MeSH terms

• Anemia, Iron-Deficiency
• Iron-deficiency

Intervention

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.

Locations

Country	Name	City	State
Pakistan	University of Veterinary and Animal Sciences	Lahore	Punjab

Sponsors (1)

Lead Sponsor	Collaborator
University of Veterinary and Animal Sciences, Lahore - Pakistan

Country where clinical trial is conducted

Pakistan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Hemoglobin Concentration From Baseline to 90 Days		Baseline, 30 days, 60 days, 90 days
Primary	Change in Hematocrit in Concentration From Baseline to 90 Days		Baseline, 30 days, 60 days, 90 days
Primary	Change in Mean Corpuscular Volume From Baseline to 90 Days		Baseline, 30 days, 60 days, 90 days
Primary	Change in Mean Corpuscular Hemoglobin From Baseline to 90 Days		Baseline, 30 days, 60 days, 90 days
Primary	Change in Mean Corpuscular Hemoglobin Concentration From Baseline to 90 Days		Baseline, 30 days, 60 days, 90 days
Primary	Change in Serum Iron Levels From Baseline to 90 Days		Baseline, 30 days, 60 days, 90 days
Primary	Change in Serum Folate Levels From Baseline to 90 Days		Baseline, 30 days, 60 days, 90 days
Primary	Change in Serum Ferritin Levels From Baseline to 90 Days		Baseline, 30 days, 60 days, 90 days
Primary	Change in Serum Transferrin Levels From Baseline to 90 Days		Baseline, 30 days, 60 days, 90 days
Primary	Change in Transferrin Saturation Factor Levels From Baseline to 90 Days		Baseline, 30 days, 60 days, 90 days
Primary	Change in Total Iron Binding Capacity Levels From Baseline to 90 Days		Baseline, 30 days, 60 days, 90 days
Secondary	Change in Liver Functions Tests (ALT) From Baseline to 90 Days		Baseline, 30 days, 60 days, 90 days
Secondary	Change in Liver Functions Tests (AST) From Baseline to 90 Days		Baseline, 30 days, 60 days, 90 days
Secondary	Change in Liver Functions Tests (ALP) From Baseline to 90 Days		Baseline, 30 days, 60 days, 90 days
Secondary	Change in Liver Functions Tests (Total Bilirubin) From Baseline to 90 Days		Baseline, 30 days, 60 days, 90 days
Secondary	Change in Renal Functions Tests (Serum Urea) From Baseline to 90 Days		Baseline, 30 days, 60 days, 90 days
Secondary	Change in Renal Functions Tests (Serum Creatinine) From Baseline to 90 Days		Baseline, 30 days, 60 days, 90 days
Secondary	Change in Immunoglobulins (IgA) From Baseline to 90 Days		Baseline, 30 days, 60 days, 90 days
Secondary	Change in Immunoglobulins (IgE) From Baseline to 90 Days		Baseline, 30 days, 60 days, 90 days
Secondary	Change in Immunoglobulins (IgG) From Baseline to 90 Days		Baseline, 30 days, 60 days, 90 days
Secondary	Change in Immunoglobulins (IgM) From Baseline to 90 Days		Baseline, 30 days, 60 days, 90 days