Iron-deficiencyPhase 1/2NCT03894449
Probing the Synergistic Effect of Pre-Biotics & Iron Fortificants in Anemic Subjects
A Phase 1/2 study testing Prebiotic + Iron Forificant in people with Iron-deficiency, run by University of Veterinary and Animal Sciences, Lahore - Pakistan at 1 site in Pakistan.
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… Read more about this study
- Who is it for?
- Ages 18 to 25 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Iron-deficiency
- What is being tested?
- Prebiotic + Iron Forificant
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 75 participants
- Where
- 1 sitePakistan
- Study dates
- 6 Apr 2019to 6 Jul 2019
- Phase
- Phase 1/2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 25 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- All willing anemic female adults without any chronic diseases such as diabetes or hypertension will be included in the study.
Who cannot join
- Married females or those with chronic diseases or those already taking iron and/or prebiotic supplements will be excluded from the study.
Trial locations and contacts
1 site in 1 country.
Pakistan1 site
University of Veterinary and Animal Sciences
Lahore, Punjab Province, 54000
About this study
Official title: Probing the Synergistic Effect of Pre-Biotics & Iron Fortificants in Anemic
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.
Read the 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).
- Conditions
- Iron-deficiency
- Being tested
- Prebiotic + Iron Forificant
- Medical subject headings
- Anemia, Iron-Deficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Prebiotic + Iron ForificantCombination product
A combination dosage of prebiotic (Inulin or GOS) and Iron Fortificant (FeSO4 or NaFeEDTA) will be given to the study subjects.
| Study group | Role | What they receive |
|---|---|---|
| Placebo only | Placebo comparator | Not described Receives: Combination Product: Prebiotic + Iron Forificant |
| Prebiotic Inulin & Iron Salt FeSO4 | Experimental | Not described Receives: Combination Product: Prebiotic + Iron Forificant |
| Prebiotic GOS & Iron Salt FeSO4 | Experimental | Not described Receives: Combination Product: Prebiotic + Iron Forificant |
| Prebiotic Inulin & Iron Salt NaFeEDTA | Experimental | Not described Receives: Combination Product: Prebiotic + Iron Forificant |
| Prebiotic GOS & Iron Salt NaFeEDTA | Experimental | Not described Receives: Combination Product: Prebiotic + Iron Forificant |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Hemoglobin Concentration From Baseline to 90 Days
Measured: Baseline, 30 days, 60 days, 90 days
Change in Hematocrit in Concentration From Baseline to 90 Days
Measured: Baseline, 30 days, 60 days, 90 days
Change in Mean Corpuscular Volume From Baseline to 90 Days
Measured: Baseline, 30 days, 60 days, 90 days
Change in Mean Corpuscular Hemoglobin From Baseline to 90 Days
Measured: Baseline, 30 days, 60 days, 90 days
Change in Mean Corpuscular Hemoglobin Concentration From Baseline to 90 Days
Measured: Baseline, 30 days, 60 days, 90 days
Change in Serum Iron Levels From Baseline to 90 Days
Measured: Baseline, 30 days, 60 days, 90 days
Change in Serum Folate Levels From Baseline to 90 Days
Measured: Baseline, 30 days, 60 days, 90 days
Change in Serum Ferritin Levels From Baseline to 90 Days
Measured: Baseline, 30 days, 60 days, 90 days
Change in Serum Transferrin Levels From Baseline to 90 Days
Measured: Baseline, 30 days, 60 days, 90 days
Change in Transferrin Saturation Factor Levels From Baseline to 90 Days
Measured: Baseline, 30 days, 60 days, 90 days
Change in Total Iron Binding Capacity Levels From Baseline to 90 Days
Measured: Baseline, 30 days, 60 days, 90 days
Secondary outcomes (10)
Change in Liver Functions Tests (ALT) From Baseline to 90 Days
Measured: Baseline, 30 days, 60 days, 90 days
Change in Liver Functions Tests (AST) From Baseline to 90 Days
Measured: Baseline, 30 days, 60 days, 90 days
Change in Liver Functions Tests (ALP) From Baseline to 90 Days
Measured: Baseline, 30 days, 60 days, 90 days
Change in Liver Functions Tests (Total Bilirubin) From Baseline to 90 Days
Measured: Baseline, 30 days, 60 days, 90 days
Change in Renal Functions Tests (Serum Urea) From Baseline to 90 Days
Measured: Baseline, 30 days, 60 days, 90 days
Change in Renal Functions Tests (Serum Creatinine) From Baseline to 90 Days
Measured: Baseline, 30 days, 60 days, 90 days
Change in Immunoglobulins (IgA) From Baseline to 90 Days
Measured: Baseline, 30 days, 60 days, 90 days
Change in Immunoglobulins (IgE) From Baseline to 90 Days
Measured: Baseline, 30 days, 60 days, 90 days
Change in Immunoglobulins (IgG) From Baseline to 90 Days
Measured: Baseline, 30 days, 60 days, 90 days
Change in Immunoglobulins (IgM) From Baseline to 90 Days
Measured: Baseline, 30 days, 60 days, 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Mar 2019
- Study start6 Apr 2019
- Primary completion6 Jul 2019
- Study completion6 Jul 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Iron-deficiencyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 75 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Veterinary and Animal Sciences, Lahore - Pakistan
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, ABDUL MOMIN RIZWAN AHMAD, University of Veterinary and Animal Sciences, Lahore - Pakistan
- Investigators
- Dr. Waqas Ahmad, PhD, Study director, University of Veterinary & Animal Sciences, Lahore, Pakistan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03894449
- Sponsor's protocol ID
- 2015-VA-04
- Status last verified
- Aug 2019
- First submitted
- 25 Mar 2019
- Last updated
- 22 Aug 2019
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: We will see what and how much data will we able to ethically share later on.
Study at a glance
From the registry record, last updated by the sponsor on 22 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Probing the Synergistic Effect of Pre-Biotics & Iron Fortificants in Anemic
- ClinicalTrials.gov ID
- NCT03894449
- Acronym / sponsor ID
- 2015-VA-04
- Conditions
- Iron-deficiency
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 75 participants (actual)
- Lead sponsor
- University of Veterinary and Animal Sciences, Lahore - PakistanUniversity, hospital or other
- Study start
- 6 Apr 2019 (actual)
- Primary completion
- 6 Jul 2019 (actual)
- Study completion
- 6 Jul 2019 (actual)
- First posted
- 28 Mar 2019 (actual)
- Results
- Posted 22 Aug 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Double blind (participant, investigator)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Placebo only | Placebo comparator | Combination Product: Prebiotic + Iron Forificant |
| Prebiotic Inulin & Iron Salt FeSO4 | Experimental | Combination Product: Prebiotic + Iron Forificant |
| Prebiotic GOS & Iron Salt FeSO4 | Experimental | Combination Product: Prebiotic + Iron Forificant |
| Prebiotic Inulin & Iron Salt NaFeEDTA | Experimental | Combination Product: Prebiotic + Iron Forificant |
| Prebiotic GOS & Iron Salt NaFeEDTA | Experimental | Combination Product: Prebiotic + Iron Forificant |
Who may qualify
- Ages
- 18 to 25 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- All willing anemic female adults without any chronic diseases such as diabetes or hypertension will be included in the study.
Key exclusion criteria (1 listed)
- Married females or those with chronic diseases or those already taking iron and/or prebiotic supplements will be excluded from the study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Prebiotic + Iron ForificantA combination dosage of prebiotic (Inulin or GOS) and Iron Fortificant (FeSO4 or NaFeEDTA) will be given to the study subjects. | Combination product | Placebo only, Prebiotic GOS & Iron Salt FeSO4, Prebiotic GOS & Iron Salt NaFeEDTA, Prebiotic Inulin & Iron Salt FeSO4, Prebiotic Inulin & Iron Salt NaFeEDTA |
Primary outcome
Change in Hemoglobin Concentration From Baseline to 90 Days
Time frame: Baseline, 30 days, 60 days, 90 days
Change in Hematocrit in Concentration From Baseline to 90 Days
Time frame: Baseline, 30 days, 60 days, 90 days
Change in Mean Corpuscular Volume From Baseline to 90 Days
Time frame: Baseline, 30 days, 60 days, 90 days
Change in Mean Corpuscular Hemoglobin From Baseline to 90 Days
Time frame: Baseline, 30 days, 60 days, 90 days
Change in Mean Corpuscular Hemoglobin Concentration From Baseline to 90 Days
Time frame: Baseline, 30 days, 60 days, 90 days
Change in Serum Iron Levels From Baseline to 90 Days
Time frame: Baseline, 30 days, 60 days, 90 days
Change in Serum Folate Levels From Baseline to 90 Days
Time frame: Baseline, 30 days, 60 days, 90 days
Change in Serum Ferritin Levels From Baseline to 90 Days
Time frame: Baseline, 30 days, 60 days, 90 days
Change in Serum Transferrin Levels From Baseline to 90 Days
Time frame: Baseline, 30 days, 60 days, 90 days
Change in Transferrin Saturation Factor Levels From Baseline to 90 Days
Time frame: Baseline, 30 days, 60 days, 90 days
Change in Total Iron Binding Capacity Levels From Baseline to 90 Days
Time frame: Baseline, 30 days, 60 days, 90 days
10 secondary outcomes
Change in Liver Functions Tests (ALT) From Baseline to 90 Days
Time frame: Baseline, 30 days, 60 days, 90 days
Change in Liver Functions Tests (AST) From Baseline to 90 Days
Time frame: Baseline, 30 days, 60 days, 90 days
Change in Liver Functions Tests (ALP) From Baseline to 90 Days
Time frame: Baseline, 30 days, 60 days, 90 days
Change in Liver Functions Tests (Total Bilirubin) From Baseline to 90 Days
Time frame: Baseline, 30 days, 60 days, 90 days
Change in Renal Functions Tests (Serum Urea) From Baseline to 90 Days
Time frame: Baseline, 30 days, 60 days, 90 days
Change in Renal Functions Tests (Serum Creatinine) From Baseline to 90 Days
Time frame: Baseline, 30 days, 60 days, 90 days
Change in Immunoglobulins (IgA) From Baseline to 90 Days
Time frame: Baseline, 30 days, 60 days, 90 days
Change in Immunoglobulins (IgE) From Baseline to 90 Days
Time frame: Baseline, 30 days, 60 days, 90 days
Change in Immunoglobulins (IgG) From Baseline to 90 Days
Time frame: Baseline, 30 days, 60 days, 90 days
Change in Immunoglobulins (IgM) From Baseline to 90 Days
Time frame: Baseline, 30 days, 60 days, 90 days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Aug 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Undecided. We will see what and how much data will we able to ethically share later on.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dr. Waqas Ahmad, PhD study director
University of Veterinary & Animal Sciences, Lahore, Pakistan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Prebiotic + Iron Forificant in people with Iron-deficiency, run by University of Veterinary and Animal Sciences, Lahore - Pakistan at 1 site in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 22 Aug 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Hemoglobin Concentration From Baseline to 90 Days (time frame: Baseline, 30 days, 60 days, 90 days). The study lists 11 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Aug 2019.