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Effect of Ferrous iROn and cUrcumin sTatus on Inflammatory and Neurotrophic markErs

NCT04465851 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 155

Last updated 2020-07-10

No results posted yet for this study

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. 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.

Conditions

  • Iron Deficiency (Without Anemia)

Interventions

DIETARY_SUPPLEMENT

Ferrous Sulphate 65 mg

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

DIETARY_SUPPLEMENT

Curcumin

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)

OTHER

Placebo (Ferrous Sulphate)

Microcrystalline cellulose Participants instructed to swallow opaque capsules with water away from meals (on an empty stomach)

OTHER

Placebo (Curcumin)

Microcrystalline cellulose Participants instructed to swallow opaque capsules with water away from meals (on an empty stomach)

DIETARY_SUPPLEMENT

Ferrous Sulphate 18mg

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

Sponsors & Collaborators

  • Gencor Pacific Group

    collaborator INDUSTRY

  • University of Westminster

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
40 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2018-07-18
Primary Completion
2019-11-11
Completion
2020-01-31

Countries

  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04465851 on ClinicalTrials.gov