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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.
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo only | Placebo Comparator |
| |
| Prebiotic Inulin & Iron Salt FeSO4 | Experimental |
| |
| Prebiotic GOS & Iron Salt FeSO4 | Experimental |
| |
| Prebiotic Inulin & Iron Salt NaFeEDTA | Experimental |
| |
| Prebiotic GOS & Iron Salt NaFeEDTA | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Hemoglobin Concentration From Baseline to 90 Days | Baseline, 30 days, 60 days, 90 days | |
| Change in Hematocrit in Concentration From Baseline to 90 Days | Baseline, 30 days, 60 days, 90 days | |
| Change in Mean Corpuscular Volume From Baseline to 90 Days | Baseline, 30 days, 60 days, 90 days | |
| Change in Mean Corpuscular Hemoglobin From Baseline to 90 Days | Baseline, 30 days, 60 days, 90 days | |
| Change in Mean Corpuscular Hemoglobin Concentration From Baseline to 90 Days | Baseline, 30 days, 60 days, 90 days | |
| Change in Serum Iron Levels From Baseline to 90 Days | Baseline, 30 days, 60 days, 90 days | |
| Change in Serum Folate Levels From Baseline to 90 Days | Baseline, 30 days, 60 days, 90 days | |
| Change in Serum Ferritin Levels From Baseline to 90 Days | Baseline, 30 days, 60 days, 90 days | |
| Change in Serum Transferrin Levels From Baseline to 90 Days | Baseline, 30 days, 60 days, 90 days | |
| Change in Transferrin Saturation Factor Levels From Baseline to 90 Days |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Liver Functions Tests (ALT) From Baseline to 90 Days | Baseline, 30 days, 60 days, 90 days | |
| Change in Liver Functions Tests (AST) From Baseline to 90 Days | Baseline, 30 days, 60 days, 90 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Dr. Waqas Ahmad, PhD | University of Veterinary & Animal Sciences, Lahore, Pakistan | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Veterinary and Animal Sciences | Lahore | Punjab Province | 54000 | Pakistan |
We will see what and how much data will we able to ethically share later on.
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| ID | Title | Description |
|---|---|---|
| FG000 | Placebo Only | Prebiotic + Iron Forificant: A combination dosage of prebiotic (Inulin or GOS) and Iron Fortificant (FeSO4 or NaFeEDTA) will be given to the study subjects. |
| FG001 | Prebiotic Inulin & Iron Salt NaFeEDTA | Prebiotic + Iron Forificant: A combination dosage of 963 mg/kg Inulin and 10 ppm NaFeEDTA was given to the study subjects. |
| FG002 | Prebiotic Inulin & Iron Salt NaFeEDTA (2) | Prebiotic + Iron Forificant: A combination dosage of 963 mg/kg Inulin and 20 ppm NaFeEDTA was given to the study subjects. |
| FG003 | Prebiotic Inulin & Iron Salt FeS04 | Prebiotic + Iron Forificant: A combination dosage of 963 mg/kg Inulin and 30 ppm FeSO4 was given to the study subjects. |
| FG004 | Prebiotic GOS & Iron Salt NaFeEDTA | Prebiotic + Iron Forificant: A combination dosage of 963 mg/kg GOS and 20 ppm NaFeEDTA was given to the study subjects. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Placebo Only | Prebiotic + Iron Forificant: A combination dosage of prebiotic (Inulin or GOS) and Iron Fortificant (FeSO4 or NaFeEDTA) will be given to the study subjects. |
| BG001 | Prebiotic Inulin & Iron Salt NaFeEDTA |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change in Hemoglobin Concentration From Baseline to 90 Days | Posted | Mean | Standard Deviation | g/dL | Baseline, 30 days, 60 days, 90 days |
|
3 months
The participants were regularly asked if they developed constipation. diarrhea or bloating during the study period, however no one developed such symptoms.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Placebo Only | Prebiotic + Iron Forificant: A combination dosage of prebiotic (Inulin or GOS) and Iron Fortificant (FeSO4 or NaFeEDTA) will be given to the study subjects. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Waqas Ahmed | University of Veterinary & Animal Sciences, Lahore, Pakistan | 0092-42-99211449 | 296 | waqas.niaz@uvas.edu.pk |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| ICF | No | No | Yes | Informed Consent Form | Jan 26, 2019 | Aug 19, 2019 | ICF_000.pdf |
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jan 11, 2019 | Aug 20, 2019 | Prot_SAP_001.pdf |
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| ID | Term |
|---|---|
| D018798 | Anemia, Iron-Deficiency |
| ID | Term |
|---|---|
| D000747 | Anemia, Hypochromic |
| D000740 | Anemia |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
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| ID | Term |
|---|---|
| D056692 | Prebiotics |
| ID | Term |
|---|---|
| D004043 | Dietary Fiber |
| D004040 | Dietary Carbohydrates |
| D002241 | Carbohydrates |
| D011135 | Polysaccharides, Bacterial |
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| Baseline, 30 days, 60 days, 90 days |
| Change in Total Iron Binding Capacity Levels From Baseline to 90 Days | Baseline, 30 days, 60 days, 90 days |
| Change in Liver Functions Tests (ALP) From Baseline to 90 Days | Baseline, 30 days, 60 days, 90 days |
| Change in Liver Functions Tests (Total Bilirubin) From Baseline to 90 Days | Baseline, 30 days, 60 days, 90 days |
| Change in Renal Functions Tests (Serum Urea) From Baseline to 90 Days | Baseline, 30 days, 60 days, 90 days |
| Change in Renal Functions Tests (Serum Creatinine) From Baseline to 90 Days | Baseline, 30 days, 60 days, 90 days |
| Change in Immunoglobulins (IgA) From Baseline to 90 Days | Baseline, 30 days, 60 days, 90 days |
| Change in Immunoglobulins (IgE) From Baseline to 90 Days | Baseline, 30 days, 60 days, 90 days |
| Change in Immunoglobulins (IgG) From Baseline to 90 Days | Baseline, 30 days, 60 days, 90 days |
| Change in Immunoglobulins (IgM) From Baseline to 90 Days | Baseline, 30 days, 60 days, 90 days |
Prebiotic + Iron Forificant: A combination dosage of 963 mg/kg Inulin and 10 ppm NaFeEDTA was given to the study subjects.
| BG002 | Prebiotic Inulin & Iron Salt NaFeEDTA (2) | Prebiotic + Iron Forificant: A combination dosage of 963 mg/kg Inulin and 20 ppm NaFeEDTA was given to the study subjects. |
| BG003 | Prebiotic Inulin & Iron Salt FeS04 | Prebiotic + Iron Forificant: A combination dosage of 963 mg/kg Inulin and 30 ppm FeSO4 was given to the study subjects. |
| BG004 | Prebiotic GOS & Iron Salt NaFeEDTA | Prebiotic + Iron Forificant: A combination dosage of 963 mg/kg GOS and 20 ppm NaFeEDTA was given to the study subjects. |
| BG005 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
Prebiotic + Iron Forificant: A combination dosage of prebiotic (Inulin or GOS) and Iron Fortificant (FeSO4 or NaFeEDTA) will be given to the study subjects. |
| OG003 | Prebiotic Inulin & Iron Salt NaFeEDTA | Prebiotic + Iron Forificant: A combination dosage of prebiotic (Inulin or GOS) and Iron Fortificant (FeSO4 or NaFeEDTA) will be given to the study subjects. |
| OG004 | Prebiotic GOS & Iron Salt NaFeEDTA | 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 | Change in Hematocrit in Concentration From Baseline to 90 Days | Posted | Mean | Standard Deviation | % of RBCs in blood | Baseline, 30 days, 60 days, 90 days |
|
|
|
| Primary | Change in Mean Corpuscular Volume From Baseline to 90 Days | Posted | Mean | Standard Deviation | fL | Baseline, 30 days, 60 days, 90 days |
|
|
|
| Primary | Change in Mean Corpuscular Hemoglobin From Baseline to 90 Days | Posted | Mean | Standard Deviation | pg | Baseline, 30 days, 60 days, 90 days |
|
|
|
| Primary | Change in Mean Corpuscular Hemoglobin Concentration From Baseline to 90 Days | Posted | Mean | Standard Deviation | g/dL | Baseline, 30 days, 60 days, 90 days |
|
|
|
| Primary | Change in Serum Iron Levels From Baseline to 90 Days | Posted | Mean | Standard Deviation | mcg/dL | Baseline, 30 days, 60 days, 90 days |
|
|
|
| Primary | Change in Serum Folate Levels From Baseline to 90 Days | Posted | Mean | Standard Deviation | ng/mL | Baseline, 30 days, 60 days, 90 days |
|
|
|
| Primary | Change in Serum Ferritin Levels From Baseline to 90 Days | Posted | Mean | Standard Deviation | ng/mL | Baseline, 30 days, 60 days, 90 days |
|
|
|
| Primary | Change in Serum Transferrin Levels From Baseline to 90 Days | Posted | Mean | Standard Deviation | mg/dL | Baseline, 30 days, 60 days, 90 days |
|
|
|
| Primary | Change in Transferrin Saturation Factor Levels From Baseline to 90 Days | Posted | Mean | Standard Deviation | % Transferrin | Baseline, 30 days, 60 days, 90 days |
|
|
|
| Primary | Change in Total Iron Binding Capacity Levels From Baseline to 90 Days | Posted | Mean | Standard Deviation | mcg/dL | Baseline, 30 days, 60 days, 90 days |
|
|
|
| Secondary | Change in Liver Functions Tests (ALT) From Baseline to 90 Days | Posted | Mean | Standard Deviation | IU/L | Baseline, 30 days, 60 days, 90 days |
|
|
|
| Secondary | Change in Liver Functions Tests (AST) From Baseline to 90 Days | Posted | Mean | Standard Deviation | IU/L | Baseline, 30 days, 60 days, 90 days |
|
|
|
| Secondary | Change in Liver Functions Tests (ALP) From Baseline to 90 Days | Posted | Mean | Standard Deviation | IU/L | Baseline, 30 days, 60 days, 90 days |
|
|
|
| Secondary | Change in Liver Functions Tests (Total Bilirubin) From Baseline to 90 Days | Posted | Mean | Standard Deviation | mg/dL | Baseline, 30 days, 60 days, 90 days |
|
|
|
| Secondary | Change in Renal Functions Tests (Serum Urea) From Baseline to 90 Days | Posted | Mean | Standard Deviation | mg/dL | Baseline, 30 days, 60 days, 90 days |
|
|
|
| Secondary | Change in Renal Functions Tests (Serum Creatinine) From Baseline to 90 Days | Posted | Mean | Standard Deviation | mg/dL | Baseline, 30 days, 60 days, 90 days |
|
|
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| Secondary | Change in Immunoglobulins (IgA) From Baseline to 90 Days | Posted | Mean | Standard Deviation | g/dL | Baseline, 30 days, 60 days, 90 days |
|
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|
| Secondary | Change in Immunoglobulins (IgE) From Baseline to 90 Days | Posted | Mean | Standard Deviation | IU/mL | Baseline, 30 days, 60 days, 90 days |
|
|
|
| Secondary | Change in Immunoglobulins (IgG) From Baseline to 90 Days | Posted | Mean | Standard Deviation | g/dL | Baseline, 30 days, 60 days, 90 days |
|
|
|
| Secondary | Change in Immunoglobulins (IgM) From Baseline to 90 Days | Posted | Mean | Standard Deviation | g/dL | Baseline, 30 days, 60 days, 90 days |
|
|
|
| 0 |
| 15 |
| 0 |
| 15 |
| 0 |
| 15 |
| EG001 | Prebiotic Inulin & Iron Salt NaFeEDTA | Prebiotic + Iron Forificant: A combination dosage of 963 mg/kg Inulin and 10 ppm NaFeEDTA was given to the study subjects. | 0 | 15 | 0 | 15 | 0 | 15 |
| EG002 | Prebiotic Inulin & Iron Salt NaFeEDTA (2) | Prebiotic + Iron Forificant: A combination dosage of 963 mg/kg Inulin and 20 ppm NaFeEDTA was given to the study subjects. | 0 | 15 | 0 | 15 | 0 | 15 |
| EG003 | Prebiotic Inulin & Iron Salt FeS04 | Prebiotic + Iron Forificant: A combination dosage of 963 mg/kg Inulin and 30 ppm FeSO4 was given to the study subjects. | 0 | 15 | 0 | 15 | 0 | 15 |
| EG004 | Prebiotic GOS & Iron Salt NaFeEDTA | Prebiotic + Iron Forificant: A combination dosage of 963 mg/kg GOS and 20 ppm NaFeEDTA was given to the study subjects. | 0 | 15 | 0 | 15 | 0 | 15 |
The research is the property of the University and we have signed an Intellectual Property Rights agreement whereby we will not disclose the study results.
| D000090463 |
| Iron Deficiencies |
| D019189 | Iron Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D011134 |
| Polysaccharides |
| D005502 | Food |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |
| D019587 | Dietary Supplements |
| D019602 | Food and Beverages |
| Between 18 and 65 years |
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| >=65 years |
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| Male |
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| 30 days |
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| 60 days |
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| 90 days |
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| 60 days |
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| 90 days |
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| 30 days |
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| 60 days |
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| 90 days |
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| 30 days |
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| 60 days |
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| 90 days |
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| 30 days |
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| 60 days |
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| 90 days |
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| 30 days |
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| 60 days |
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| 90 days |
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| 30 days |
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| 60 days |
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| 90 days |
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| 30 days |
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| 60 days |
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| 90 days |
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| 30 days |
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| 60 days |
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| 90 days |
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| 30 days |
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| 60 days |
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| 90 days |
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| 30 days ALT |
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| 60 days ALT |
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| 90 days ALT |
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| 30 days AST |
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| 60 days AST |
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| 90 days AST |
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| 30 days ALP |
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| 60 days ALP |
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| 90 days ALP |
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| 30 days Total Bilirubin |
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| 60 days Total Bilirubin |
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| 90 days Total Bilirubin |
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| 30 days Serum Urea |
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| 60 days Serum Urea |
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| 90 days Serum Urea |
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| 30 days Serum Creatinine |
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| 60 days Serum Creatinine |
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| 90 days Serum Creatinine |
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| 30 days IgA |
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| 60 days IgA |
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| 90 days IgA |
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| 30 days IgE |
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| 60 days IgE |
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| 90 days IgE |
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| 30 days IgG |
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| 60 days IgG |
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| 90 days IgG |
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| 30 days IgM |
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| 60 days IgM |
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| 90 days IgM |
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