Iron Deficiency (Without Anemia)Fe-ROUTINENCT04465851
Effect of Ferrous iROn and cUrcumin sTatus on Inflammatory and Neurotrophic markErs
A study testing Ferrous Sulphate 65 mg, Curcumin and Ferrous Sulphate 18mg in people with Iron Deficiency (Without Anemia), run by University of Westminster at 1 site in United Kingdom.
Trial summary
INTRODUCTION: Iron is a vital nutrient for many physiological processes including DNA production, oxygen transport and neuronal processes. However, several factors limit iron absorption including: limited bioavailability of iron (dietary or supplementation sources), can be subject to dietary iron inhibitors (e.g. Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Iron Deficiency (Without Anemia)
- What is being tested?
- Ferrous Sulphate 65 mg, Curcumin and Ferrous Sulphate 18mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 155 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 18 Jul 2018to 31 Jan 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Males \& Females (18-40 years of age)
- Healthy subjects
Who cannot join
- <18 years or >40 years
- Dieters
- Consumption of >21 serving of alcohol/week
- Any allergies/health issues related to items being ingested
- Any serious illnesses or those on medication
- Any pregnant or lactating women
Show all 15Show fewer
- Any women who are trying to conceive
- Any women taking contraceptive medication
- Any gastrointestinal disorders
- Any chronic menstrual disorders
- Any subjects who have undergone the menopause or undergoing the perimenopause transition
- Any eating disorders
- Any depression/mental disorders
- Any abnormal blood pressure levels
- Those with deficient/excess/abnormal iron levels according to United Kingdom (UK) guidelines \&/or haemochromatosis
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of HydroCurc™ Curcumin and Ferrous Iron Supplementation on Iron Status and Inflammatory and Neurotrophic Marker Levels in Healthy Adults
INTRODUCTION: Iron is a vital nutrient for many physiological processes including DNA production, oxygen transport and neuronal processes. However, several factors limit iron absorption including: limited bioavailability of iron (dietary or supplementation sources), can be subject to dietary iron inhibitors (e.g. calcium). Excess iron can cause cellular oxidative stress in the body.
Curcumin is an active component found in turmeric, known for its anti-oxidant and anti-inflammatory properties. Co-administration of iron and curcumin may influence iron, inflammatory status and/or neurotrophic markers in the body.
Read the detailed description
Intervention study with five parallel treatment groups in a randomised, double-blind, placebo-controlled design.
Study population: Healthy Participants (Male or Female) will receive daily supplements (active or equivalent placebos) for 6 weeks (42 days)
Biological samples (blood and urine samples) are collected at baseline visit (day 1), mid-point (day 21) and end-point (day 42). In addition, pertinent questionnaires (Visual Analogue Scale-Fatigue [VAS-F] and oral iron supplement questionnaire will be collected at the aforementioned time points.
- Conditions
- Iron Deficiency (Without Anemia)
- Being tested
- Ferrous Sulphate 65 mg, Curcumin, Placebo (Ferrous Sulphate), Placebo (Curcumin), Ferrous Sulphate 18mg
- Keywords
- nutraceutical, anti-oxidant, oxidative status, ferrous sulphate, curcumin, inflammatory status, turmeric, gastrointestinal, fatigue, iron, Hydrocurc, supplement
- Medical subject headings
- Iron Deficiencies, Fatigue
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ferrous Sulphate 65 mgDietary supplement
Also called Ferrous Sulfate
Oral ferrous salt supplement Ferrous Sulphate 200 mg (equiv. 65 mg elemental iron content)
Participants instructed to swallow opaque capsules with water away from meals (on an empty stomach)
At the mid-point visit day (day 21) and the finally at the end-point (day 42) compliance will be verified by counting capsules
CurcuminDietary supplement
Also called Turmeric, Curcuma longa
HydroCurc™ 500 mg formulated curcumin
At the mid-point visit day (day 21) and the finally at the end-point (day 42) compliance will be verified by counting capsules
Participants instructed to swallow opaque capsules with water away from meals (on an empty stomach)
Placebo (Ferrous Sulphate)Other
Microcrystalline cellulose
Participants instructed to swallow opaque capsules with water away from meals (on an empty stomach)
Placebo (Curcumin)Other
Microcrystalline cellulose
Participants instructed to swallow opaque capsules with water away from meals (on an empty stomach)
Ferrous Sulphate 18mgDietary supplement
Also called Ferrous Sulfate
Oral ferrous salt supplement
Ferrous Sulphate 55 mg (equiv. 18 mg elemental iron content)
Participants instructed to swallow opaque capsules with water away from meals (on an empty stomach)
At the mid-point visit day (day 21) and the finally at the end-point (day 42) compliance will be verified by counting capsules
| Study group | Role | What they receive |
|---|---|---|
| FS65_Curc | Active comparator | Ferrous Sulphate (65 mg/day elemental iron) and Curcumin 500 mg/day Receives: Dietary Supplement: Ferrous Sulphate 65 mg; Dietary Supplement: Curcumin |
| FS65_Plac | Placebo comparator | Ferrous Sulphate (65 mg/day elemental iron) and Placebo (Curcumin placebo [cellulose]) Receives: Dietary Supplement: Ferrous Sulphate 65 mg; Other: Placebo (Curcumin) |
| FS0_Plac | Placebo comparator | Placebo (Ferrous Sulphate placebo [cellulose]) and Placebo (Curcumin placebo [cellulose]) Receives: Other: Placebo (Ferrous Sulphate); Other: Placebo (Curcumin) |
| FS18_Plac | Placebo comparator | Ferrous Sulphate (18 mg/day elemental iron) and Placebo (Curcumin placebo [cellulose]) Receives: Other: Placebo (Curcumin); Dietary Supplement: Ferrous Sulphate 18mg |
| FS18_Curc | Active comparator | Ferrous Sulphate (18 mg/day elemental iron) and Curcumin 500 mg/day Receives: Dietary Supplement: Curcumin; Dietary Supplement: Ferrous Sulphate 18mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
To assess the influence of HydroCurc™ administration on ferrous iron supplementation associated inflammation
Marker: Interleukin 6 (pg/mL), Interleukin 10 (pg/mL), Interleukin 1 beta (pg/mL)
Measured: Change in Interleukin 6, Interleukin 10 and Interleukin 1 beta (ELISA) from day 1 compared to day 21 (baseline to midpoint), day 1 compared to day 42 (baseline to endpoint) and day 21 compared to day 42 (midpoint to endpoint)
To assess the influence of HydroCurc™ administration on ferrous iron supplementation associated inflammation
Tumour Necrosis Factor alpha (pg/mL)
Measured: Change in Tumour Necrosis Factor alpha (ELISA) from day 1 compared to day 21 (baseline to midpoint), day 1 compared to day 42 (baseline to endpoint) and day 21 compared to day 42 (midpoint to endpoint)
To assess the influence of HydroCurc™ administration on ferrous iron supplementation associated inflammation
Marker: C-Reactive Protein (g/L)
Measured: Change in C-Reactive Protein (immunoassay) from day 1 compared to day 21 (baseline to midpoint), day 1 compared to day 42 (baseline to endpoint) and day 21 compared to day 42 (midpoint to endpoint)
To assess the influence of HydroCurc™ administration on ferrous iron supplementation associated lipid peroxidation
Marker: thiobarbituric acid reactive substances (μM)
Measured: Change in thiobarbituric acid reactive substances (ELISA) from day 1 compared to day 21 (baseline to midpoint), day 1 compared to day 42 (baseline to endpoint) and day 21 compared to day 42 (midpoint to endpoint)
To assess the influence of HydroCurc™ administration on ferrous iron supplementation associated acute iron absorption
Marker: serum iron (μmol/L)
Measured: Change in serum iron (colorimetric analyser) from 0 and 180 minutes following supplementation
To assess the influence of HydroCurc™ administration on ferrous iron supplementation associated acute iron absorption
Marker: total iron binding capacity (μmol/L)
Measured: Change in total iron binding capacity (colorimetric analyser) from 0 and 180 minutes following supplementation
To assess the influence of HydroCurc™ administration on ferrous iron supplementation associated iron status
Marker: serum iron (μmol/L)
Measured: Change in serum iron (colorimetric analyser) from day 1 compared to day 21 (baseline to midpoint), day 1 compared to day 42 (baseline to endpoint) and day 21 compared to day 42 (midpoint to endpoint)
To assess the influence of HydroCurc™ administration on ferrous iron supplementation associated iron status
Marker: total iron binding capacity (μmol/L)
Measured: Change in total iron binding capacity (colorimetric analyser) from day 1 compared to day 21 (baseline to midpoint), day 1 compared to day 42 (baseline to endpoint) and day 21 compared to day 42 (midpoint to endpoint)
To assess the influence of HydroCurc™ administration on ferrous iron supplementation associated iron status
Marker: Ferritin (ng/mL)
Measured: Change in ferritin (immunoassay) from day 1 compared to day 21 (baseline to midpoint), day 1 compared to day 42 (baseline to endpoint) and day 21 compared to day 42 (midpoint to endpoint)
To assess the influence of HydroCurc™ administration on ferrous iron supplementation associated iron status
Marker: Haemoglobin (g/dL)
Measured: Change in haemoglobin (whole blood analyser) from day 1 compared to day 21 (baseline to midpoint), day 1 compared to day 42 (baseline to endpoint) and day 21 compared to day 42 (midpoint to endpoint)
To assess the influence of HydroCurc™ administration on ferrous iron supplementation associated iron status
Marker: Red blood cells (M/μL)
Measured: Change in red blood cells (whole blood analyser) from day 1 compared to day 21 (baseline to midpoint), day 1 compared to day 42 (baseline to endpoint) and day 21 compared to day 42 (midpoint to endpoint)
Secondary outcomes (4)
To assess the influence of HydroCurc™ administration on ferrous iron supplementation associated neurotrophic levels
Marker: Brain derived neurotrophic factor (BDNF) (ng/mL)
Measured: Change in BDNF (ELISA) from baseline to endpoint from day 1 compared to day 21 (baseline to midpoint), day 1 compared to day 42 (baseline to endpoint) and day 21 compared to day 42 (midpoint to endpoint)
To assess the influence of HydroCurc™ administration on ferrous iron supplementation associated gastrointestinal effects
Subjective analysis including: Oral Iron Supplement Questionnaire
Measured: Change in reported subjective gastrointestinal effects from day 1 compared to day 21 (baseline to midpoint), day 1 compared to day 42 (baseline to endpoint) and day 21 compared to day 42 (midpoint to endpoint)
To assess the influence of HydroCurc™ administration on ferrous iron supplementation associated perception of fatigue
Subjective analysis including: Visual Analogue Scale for Fatigue (VAS-F). Scores range from 0 to 100 (the higher the score the greater the level of fatigue)
Measured: Change in VAS-F from day 1 compared to day 21 (baseline to midpoint), day 1 compared to day 42 (baseline to endpoint) and day 21 compared to day 42 (midpoint to endpoint)
To assess the influence of HydroCurc™ administration on ferrous iron supplementation associated perception of fatigue
Subjective analysis including: Fatigue Severity Scale (FSS). The total score of all answers indicates level of fatigue (a total score above ≥ 36 indicates fatigue).
Measured: Change in FSS from day 1 compared to day 21 (baseline to midpoint), day 1 compared to day 42 (baseline to endpoint) and day 21 compared to day 42 (midpoint to endpoint)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jul 2020
- Study start18 Jul 2018
- Primary completion11 Nov 2019
- Study completion31 Jan 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Iron Deficiency (Without Anemia)Studies 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 N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Allocation: Randomisation (block) Intervention Model: Parallel, Randomised placebo-controlled design Masking: Double-blind
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 155 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Westminster
- Sponsor type
- University, hospital or other
- Collaborators
- Gencor Pacific Group
- Responsible party
- Principal investigator, Mohammed Gulrez Zariwala, University of Westminster
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04465851
- Sponsor's protocol ID
- ETH1718-0907
- Acronym
- Fe-ROUTINE
- Status last verified
- Jul 2020
- First submitted
- 23 Jun 2020
- Last updated
- 10 Jul 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of HydroCurc™ Curcumin and Ferrous Iron Supplementation on Iron Status and Inflammatory and Neurotrophic Marker Levels in Healthy Adults
- ClinicalTrials.gov ID
- NCT04465851
- Acronym / sponsor ID
- Fe-ROUTINE / ETH1718-0907
- Conditions
- Iron Deficiency (Without Anemia)
- Keywords
- nutraceutical, anti-oxidant, oxidative status, ferrous sulphate, curcumin, inflammatory status, turmeric, gastrointestinal
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 155 participants (actual)
- Lead sponsor
- University of WestminsterUniversity, hospital or other
- Collaborators
- Gencor Pacific Group
- Study start
- 18 Jul 2018 (actual)
- Primary completion
- 11 Nov 2019 (actual)
- Study completion
- 31 Jan 2020 (actual)
- First posted
- 10 Jul 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
INTRODUCTION: Iron is a vital nutrient for many physiological processes including DNA production, oxygen transport and neuronal processes. However, several factors limit iron absorption including: limited bioavailability of iron (dietary or supplementation sources), can be subject to dietary iron inhibitors (e.g. calcium). Excess iron can cause cellular oxidative stress in the body.
Curcumin is an active component found in turmeric, known for its anti-oxidant and anti-inflammatory properties. Co-administration of iron and curcumin may influence iron, inflammatory status and/or neurotrophic markers in the body.
Detailed description
Intervention study with five parallel treatment groups in a randomised, double-blind, placebo-controlled design.
Study population: Healthy Participants (Male or Female) will receive daily supplements (active or equivalent placebos) for 6 weeks (42 days)
Biological samples (blood and urine samples) are collected at baseline visit (day 1), mid-point (day 21) and end-point (day 42). In addition, pertinent questionnaires (Visual Analogue Scale-Fatigue [VAS-F] and oral iron supplement questionnaire will be collected at the aforementioned time points.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 5
- Model description
- Allocation: Randomisation (block) Intervention Model: Parallel, Randomised placebo-controlled design Masking: Double-blind
| Arm | Type | Receives |
|---|---|---|
| FS65_Curc | Active comparator | Dietary Supplement: Ferrous Sulphate 65 mg, Dietary Supplement: CurcuminFerrous Sulphate (65 mg/day elemental iron) and Curcumin 500 mg/day |
| FS65_Plac | Placebo comparator | Dietary Supplement: Ferrous Sulphate 65 mg, Other: Placebo (Curcumin)Ferrous Sulphate (65 mg/day elemental iron) and Placebo (Curcumin placebo [cellulose]) |
| FS0_Plac | Placebo comparator | Other: Placebo (Ferrous Sulphate), Other: Placebo (Curcumin)Placebo (Ferrous Sulphate placebo [cellulose]) and Placebo (Curcumin placebo [cellulose]) |
| FS18_Plac | Placebo comparator | Other: Placebo (Curcumin), Dietary Supplement: Ferrous Sulphate 18mgFerrous Sulphate (18 mg/day elemental iron) and Placebo (Curcumin placebo [cellulose]) |
| FS18_Curc | Active comparator | Dietary Supplement: Curcumin, Dietary Supplement: Ferrous Sulphate 18mgFerrous Sulphate (18 mg/day elemental iron) and Curcumin 500 mg/day |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Males \& Females (18-40 years of age)
- Healthy subjects
Key exclusion criteria (15 listed)
- <18 years or >40 years
- Dieters
- Consumption of >21 serving of alcohol/week
- Any allergies/health issues related to items being ingested
- Any serious illnesses or those on medication
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 |
|---|---|---|
| Ferrous Sulphate 65 mgAlso: Ferrous SulfateOral ferrous salt supplement Ferrous Sulphate 200 mg (equiv. 65 mg elemental iron content) Participants instructed to swallow opaque capsules with water away from meals (on an empty stomach) At the mid-point visit day (day 21) and the finally at the end-point (day 42) compliance will be verified by counting capsules | Dietary supplement | FS65_Curc, FS65_Plac |
| CurcuminAlso: Turmeric, Curcuma longaHydroCurc™ 500 mg formulated curcumin At the mid-point visit day (day 21) and the finally at the end-point (day 42) compliance will be verified by counting capsules Participants instructed to swallow opaque capsules with water away from meals (on an empty stomach) | Dietary supplement | FS18_Curc, FS65_Curc |
| Placebo (Ferrous Sulphate)Microcrystalline cellulose Participants instructed to swallow opaque capsules with water away from meals (on an empty stomach) | Other | FS0_Plac |
| Placebo (Curcumin)Microcrystalline cellulose Participants instructed to swallow opaque capsules with water away from meals (on an empty stomach) | Other | FS0_Plac, FS18_Plac, FS65_Plac |
| Ferrous Sulphate 18mgAlso: Ferrous SulfateOral ferrous salt supplement Ferrous Sulphate 55 mg (equiv. 18 mg elemental iron content) Participants instructed to swallow opaque capsules with water away from meals (on an empty stomach) At the mid-point visit day (day 21) and the finally at the end-point (day 42) compliance will be verified by counting capsules | Dietary supplement | FS18_Curc, FS18_Plac |
Primary outcome
To assess the influence of HydroCurc™ administration on ferrous iron supplementation associated inflammation
Time frame: Change in Interleukin 6, Interleukin 10 and Interleukin 1 beta (ELISA) from day 1 compared to day 21 (baseline to midpoint), day 1 compared to day 42 (baseline to endpoint) and day 21 compared to day 42 (midpoint to endpoint)
Marker: Interleukin 6 (pg/mL), Interleukin 10 (pg/mL), Interleukin 1 beta (pg/mL)
To assess the influence of HydroCurc™ administration on ferrous iron supplementation associated inflammation
Time frame: Change in Tumour Necrosis Factor alpha (ELISA) from day 1 compared to day 21 (baseline to midpoint), day 1 compared to day 42 (baseline to endpoint) and day 21 compared to day 42 (midpoint to endpoint)
Tumour Necrosis Factor alpha (pg/mL)
To assess the influence of HydroCurc™ administration on ferrous iron supplementation associated inflammation
Time frame: Change in C-Reactive Protein (immunoassay) from day 1 compared to day 21 (baseline to midpoint), day 1 compared to day 42 (baseline to endpoint) and day 21 compared to day 42 (midpoint to endpoint)
Marker: C-Reactive Protein (g/L)
To assess the influence of HydroCurc™ administration on ferrous iron supplementation associated lipid peroxidation
Time frame: Change in thiobarbituric acid reactive substances (ELISA) from day 1 compared to day 21 (baseline to midpoint), day 1 compared to day 42 (baseline to endpoint) and day 21 compared to day 42 (midpoint to endpoint)
Marker: thiobarbituric acid reactive substances (μM)
To assess the influence of HydroCurc™ administration on ferrous iron supplementation associated acute iron absorption
Time frame: Change in serum iron (colorimetric analyser) from 0 and 180 minutes following supplementation
Marker: serum iron (μmol/L)
To assess the influence of HydroCurc™ administration on ferrous iron supplementation associated acute iron absorption
Time frame: Change in total iron binding capacity (colorimetric analyser) from 0 and 180 minutes following supplementation
Marker: total iron binding capacity (μmol/L)
To assess the influence of HydroCurc™ administration on ferrous iron supplementation associated iron status
Time frame: Change in serum iron (colorimetric analyser) from day 1 compared to day 21 (baseline to midpoint), day 1 compared to day 42 (baseline to endpoint) and day 21 compared to day 42 (midpoint to endpoint)
Marker: serum iron (μmol/L)
To assess the influence of HydroCurc™ administration on ferrous iron supplementation associated iron status
Time frame: Change in total iron binding capacity (colorimetric analyser) from day 1 compared to day 21 (baseline to midpoint), day 1 compared to day 42 (baseline to endpoint) and day 21 compared to day 42 (midpoint to endpoint)
Marker: total iron binding capacity (μmol/L)
To assess the influence of HydroCurc™ administration on ferrous iron supplementation associated iron status
Time frame: Change in ferritin (immunoassay) from day 1 compared to day 21 (baseline to midpoint), day 1 compared to day 42 (baseline to endpoint) and day 21 compared to day 42 (midpoint to endpoint)
Marker: Ferritin (ng/mL)
To assess the influence of HydroCurc™ administration on ferrous iron supplementation associated iron status
Time frame: Change in haemoglobin (whole blood analyser) from day 1 compared to day 21 (baseline to midpoint), day 1 compared to day 42 (baseline to endpoint) and day 21 compared to day 42 (midpoint to endpoint)
Marker: Haemoglobin (g/dL)
To assess the influence of HydroCurc™ administration on ferrous iron supplementation associated iron status
Time frame: Change in red blood cells (whole blood analyser) from day 1 compared to day 21 (baseline to midpoint), day 1 compared to day 42 (baseline to endpoint) and day 21 compared to day 42 (midpoint to endpoint)
Marker: Red blood cells (M/μL)
4 secondary outcomes
To assess the influence of HydroCurc™ administration on ferrous iron supplementation associated neurotrophic levels
Time frame: Change in BDNF (ELISA) from baseline to endpoint from day 1 compared to day 21 (baseline to midpoint), day 1 compared to day 42 (baseline to endpoint) and day 21 compared to day 42 (midpoint to endpoint)
To assess the influence of HydroCurc™ administration on ferrous iron supplementation associated gastrointestinal effects
Time frame: Change in reported subjective gastrointestinal effects from day 1 compared to day 21 (baseline to midpoint), day 1 compared to day 42 (baseline to endpoint) and day 21 compared to day 42 (midpoint to endpoint)
To assess the influence of HydroCurc™ administration on ferrous iron supplementation associated perception of fatigue
Time frame: Change in VAS-F from day 1 compared to day 21 (baseline to midpoint), day 1 compared to day 42 (baseline to endpoint) and day 21 compared to day 42 (midpoint to endpoint)
To assess the influence of HydroCurc™ administration on ferrous iron supplementation associated perception of fatigue
Time frame: Change in FSS from day 1 compared to day 21 (baseline to midpoint), day 1 compared to day 42 (baseline to endpoint) and day 21 compared to day 42 (midpoint to endpoint)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jul 2020.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ferrous Sulphate 65 mg, Curcumin and Ferrous Sulphate 18mg in people with Iron Deficiency (Without Anemia), run by University of Westminster at 1 site in United Kingdom.
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 2 inclusion and 15 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 10 Jul 2020. 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 United Kingdom. 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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
To assess the influence of HydroCurc™ administration on ferrous iron supplementation associated inflammation (time frame: Change in Interleukin 6, Interleukin 10 and Interleukin 1 beta (ELISA) from day 1 compared to day 21 (baseline to midpoint), day 1 compared to day 42 (baseline to endpoint) and day 21 compared to day 42 (midpoint to endpoint)). 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 10 Jul 2020.