Ignite Creation Date:
2025-12-24 @ 11:51 PM
Ignite Modification Date:
2026-01-03 @ 10:29 AM
Study NCT ID:
NCT04465851
Status:
COMPLETED
Last Update Posted:
2020-07-10
First Post:
2020-06-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of Ferrous iROn and cUrcumin sTatus on Inflammatory and Neurotrophic markErs
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000090463', 'term': 'Iron Deficiencies'}, {'id': 'D005221', 'term': 'Fatigue'}], 'ancestors': [{'id': 'D019189', 'term': 'Iron Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C020748', 'term': 'ferrous sulfate'}, {'id': 'D003474', 'term': 'Curcumin'}, {'id': 'C012596', 'term': 'turmeric extract'}], 'ancestors': [{'id': 'D036381', 'term': 'Diarylheptanoids'}, {'id': 'D006536', 'term': 'Heptanes'}, {'id': 'D000473', 'term': 'Alkanes'}, {'id': 'D006839', 'term': 'Hydrocarbons, Acyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D002396', 'term': 'Catechols'}, {'id': 'D010636', 'term': 'Phenols'}, {'id': 'D001555', 'term': 'Benzene Derivatives'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR'], 'maskingDescription': 'Participants (and supplements) will be coded and randomly allocated (applied randomly by software \\[gender balanced\\[) to treatment arms to eliminate order effects and maintain research staff blinding.'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Allocation: Randomisation (block) Intervention Model: Parallel, Randomised placebo-controlled design Masking: Double-blind'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 155}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-07-18', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-07', 'completionDateStruct': {'date': '2020-01-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-07-06', 'studyFirstSubmitDate': '2020-06-23', 'studyFirstSubmitQcDate': '2020-07-06', 'lastUpdatePostDateStruct': {'date': '2020-07-10', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-07-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-11-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'To assess the influence of HydroCurc™ administration on ferrous iron supplementation associated inflammation', 'timeFrame': '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)', 'description': 'Marker: Interleukin 6 (pg/mL), Interleukin 10 (pg/mL), Interleukin 1 beta (pg/mL)'}, {'measure': 'To assess the influence of HydroCurc™ administration on ferrous iron supplementation associated inflammation', 'timeFrame': '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)', 'description': 'Tumour Necrosis Factor alpha (pg/mL)'}, {'measure': 'To assess the influence of HydroCurc™ administration on ferrous iron supplementation associated inflammation', 'timeFrame': '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)', 'description': 'Marker: C-Reactive Protein (g/L)'}, {'measure': 'To assess the influence of HydroCurc™ administration on ferrous iron supplementation associated lipid peroxidation', 'timeFrame': '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)', 'description': 'Marker: thiobarbituric acid reactive substances (μM)'}, {'measure': 'To assess the influence of HydroCurc™ administration on ferrous iron supplementation associated acute iron absorption', 'timeFrame': 'Change in serum iron (colorimetric analyser) from 0 and 180 minutes following supplementation', 'description': 'Marker: serum iron (μmol/L)'}, {'measure': 'To assess the influence of HydroCurc™ administration on ferrous iron supplementation associated acute iron absorption', 'timeFrame': 'Change in total iron binding capacity (colorimetric analyser) from 0 and 180 minutes following supplementation', 'description': 'Marker: total iron binding capacity (μmol/L)'}, {'measure': 'To assess the influence of HydroCurc™ administration on ferrous iron supplementation associated iron status', 'timeFrame': '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)', 'description': 'Marker: serum iron (μmol/L)'}, {'measure': 'To assess the influence of HydroCurc™ administration on ferrous iron supplementation associated iron status', 'timeFrame': '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)', 'description': 'Marker: total iron binding capacity (μmol/L)'}, {'measure': 'To assess the influence of HydroCurc™ administration on ferrous iron supplementation associated iron status', 'timeFrame': '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)', 'description': 'Marker: Ferritin (ng/mL)'}, {'measure': 'To assess the influence of HydroCurc™ administration on ferrous iron supplementation associated iron status', 'timeFrame': '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)', 'description': 'Marker: Haemoglobin (g/dL)'}, {'measure': 'To assess the influence of HydroCurc™ administration on ferrous iron supplementation associated iron status', 'timeFrame': '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)', 'description': 'Marker: Red blood cells (M/μL)'}], 'secondaryOutcomes': [{'measure': 'To assess the influence of HydroCurc™ administration on ferrous iron supplementation associated neurotrophic levels', 'timeFrame': '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)', 'description': 'Marker: Brain derived neurotrophic factor (BDNF) (ng/mL)'}, {'measure': 'To assess the influence of HydroCurc™ administration on ferrous iron supplementation associated gastrointestinal effects', 'timeFrame': '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)', 'description': 'Subjective analysis including: Oral Iron Supplement Questionnaire'}, {'measure': 'To assess the influence of HydroCurc™ administration on ferrous iron supplementation associated perception of fatigue', 'timeFrame': '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)', 'description': '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)'}, {'measure': 'To assess the influence of HydroCurc™ administration on ferrous iron supplementation associated perception of fatigue', 'timeFrame': '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)', 'description': 'Subjective analysis including: Fatigue Severity Scale (FSS). The total score of all answers indicates level of fatigue (a total score above ≥ 36 indicates fatigue).'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['nutraceutical', 'anti-oxidant', 'oxidative status', 'ferrous sulphate', 'curcumin', 'inflammatory status', 'turmeric', 'gastrointestinal', 'fatigue', 'iron', 'Hydrocurc', 'supplement'], 'conditions': ['Iron Deficiency (Without Anemia)']}, 'descriptionModule': {'briefSummary': '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.\n\nCurcumin 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.', 'detailedDescription': 'Intervention study with five parallel treatment groups in a randomised, double-blind, placebo-controlled design.\n\nStudy population: Healthy Participants (Male or Female) will receive daily supplements (active or equivalent placebos) for 6 weeks (42 days)\n\nBiological 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '40 Years', 'minimumAge': '18 Years', 'genderBased': True, 'genderDescription': 'Male or Female', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Males \\& Females (18-40 years of age)\n* Healthy subjects\n\nExclusion Criteria:\n\n* \\<18 years or \\>40 years\n* Dieters\n* Consumption of \\>21 serving of alcohol/week\n* Any allergies/health issues related to items being ingested\n* Any serious illnesses or those on medication\n* Any pregnant or lactating women\n* Any women who are trying to conceive\n* Any women taking contraceptive medication\n* Any gastrointestinal disorders\n* Any chronic menstrual disorders\n* Any subjects who have undergone the menopause or undergoing the perimenopause transition\n* Any eating disorders\n* Any depression/mental disorders\n* Any abnormal blood pressure levels\n* Those with deficient/excess/abnormal iron levels according to United Kingdom (UK) guidelines \\&/or haemochromatosis'}, 'identificationModule': {'nctId': 'NCT04465851', 'acronym': 'Fe-ROUTINE', 'briefTitle': 'Effect of Ferrous iROn and cUrcumin sTatus on Inflammatory and Neurotrophic markErs', 'organization': {'class': 'OTHER', 'fullName': 'University of Westminster'}, 'officialTitle': 'The Effect of HydroCurc™ Curcumin and Ferrous Iron Supplementation on Iron Status and Inflammatory and Neurotrophic Marker Levels in Healthy Adults', 'orgStudyIdInfo': {'id': 'ETH1718-0907'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'FS65_Curc', 'description': 'Ferrous Sulphate (65 mg/day elemental iron) and Curcumin 500 mg/day', 'interventionNames': ['Dietary Supplement: Ferrous Sulphate 65 mg', 'Dietary Supplement: Curcumin']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'FS65_Plac', 'description': 'Ferrous Sulphate (65 mg/day elemental iron) and Placebo (Curcumin placebo \\[cellulose\\])', 'interventionNames': ['Dietary Supplement: Ferrous Sulphate 65 mg', 'Other: Placebo (Curcumin)']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'FS0_Plac', 'description': 'Placebo (Ferrous Sulphate placebo \\[cellulose\\]) and Placebo (Curcumin placebo \\[cellulose\\])', 'interventionNames': ['Other: Placebo (Ferrous Sulphate)', 'Other: Placebo (Curcumin)']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'FS18_Plac', 'description': 'Ferrous Sulphate (18 mg/day elemental iron) and Placebo (Curcumin placebo \\[cellulose\\])', 'interventionNames': ['Other: Placebo (Curcumin)', 'Dietary Supplement: Ferrous Sulphate 18mg']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'FS18_Curc', 'description': 'Ferrous Sulphate (18 mg/day elemental iron) and Curcumin 500 mg/day', 'interventionNames': ['Dietary Supplement: Curcumin', 'Dietary Supplement: Ferrous Sulphate 18mg']}], 'interventions': [{'name': 'Ferrous Sulphate 65 mg', 'type': 'DIETARY_SUPPLEMENT', 'otherNames': ['Ferrous Sulfate'], 'description': 'Oral ferrous salt supplement Ferrous Sulphate 200 mg (equiv. 65 mg elemental iron content)\n\nParticipants instructed to swallow opaque capsules with water away from meals (on an empty stomach)\n\nAt the mid-point visit day (day 21) and the finally at the end-point (day 42) compliance will be verified by counting capsules', 'armGroupLabels': ['FS65_Curc', 'FS65_Plac']}, {'name': 'Curcumin', 'type': 'DIETARY_SUPPLEMENT', 'otherNames': ['Turmeric', 'Curcuma longa'], 'description': 'HydroCurc™ 500 mg formulated curcumin\n\nAt the mid-point visit day (day 21) and the finally at the end-point (day 42) compliance will be verified by counting capsules\n\nParticipants instructed to swallow opaque capsules with water away from meals (on an empty stomach)', 'armGroupLabels': ['FS18_Curc', 'FS65_Curc']}, {'name': 'Placebo (Ferrous Sulphate)', 'type': 'OTHER', 'description': 'Microcrystalline cellulose\n\nParticipants instructed to swallow opaque capsules with water away from meals (on an empty stomach)', 'armGroupLabels': ['FS0_Plac']}, {'name': 'Placebo (Curcumin)', 'type': 'OTHER', 'description': 'Microcrystalline cellulose\n\nParticipants instructed to swallow opaque capsules with water away from meals (on an empty stomach)', 'armGroupLabels': ['FS0_Plac', 'FS18_Plac', 'FS65_Plac']}, {'name': 'Ferrous Sulphate 18mg', 'type': 'DIETARY_SUPPLEMENT', 'otherNames': ['Ferrous Sulfate'], 'description': 'Oral ferrous salt supplement\n\nFerrous Sulphate 55 mg (equiv. 18 mg elemental iron content)\n\nParticipants instructed to swallow opaque capsules with water away from meals (on an empty stomach)\n\nAt the mid-point visit day (day 21) and the finally at the end-point (day 42) compliance will be verified by counting capsules', 'armGroupLabels': ['FS18_Curc', 'FS18_Plac']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'W1W 6UW', 'city': 'London', 'country': 'United Kingdom', 'facility': 'University of Westminster', 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Westminster', 'class': 'OTHER'}, 'collaborators': [{'name': 'Gencor Pacific Group', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Reader in Translational Physiology', 'investigatorFullName': 'Mohammed Gulrez Zariwala', 'investigatorAffiliation': 'University of Westminster'}}}}