The Potential Benefits of Ginger Supplementation in Individuals With Iron Deficiency: a Randomised Controlled Pilot Study.

Not Applicable

Recruiting

• Conditions: Iron Deficiency; Blood - Anaemia; Diet and Nutrition - Other diet and nutrition disorders

• Registration Number: ACTRN12622001337763
• Lead Sponsor: The Oaks Medical Practice

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2022-10-18
• Last Update Posted: 6 May 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

1. Adults aged 18 and over
2. Confirmed iron deficiency (ID) diagnosis with SF level less than 30 µg/L with normal or slightly lower than normal Hb level (Hb greater than or equal to 110 g/L)
3. Adequately maintained liver and renal functions with the following laboratory
parameters less than 2x Upper Limit of Normal:
a. Alanine transaminase (ALT), aspartate aminotransferase (AST), and gamma-glutamyl transferase (GGT)
b. Blood urea nitrogen (BUN) and creatinine
4. Functional grade based on ECOG Performance Status is between 0 to 2
5. Received explanation of the purpose and methods of the study and provided written
consent at the point of recruitment

Exclusion Criteria

1. A mental health condition that may impede the patient’s ability to provide informed consent
2. Having diagnosed with an eating disorder or demonstrating certain behavioural, physical and psychological signs or changes that often accompany an eating disorder
3. Known or possible pregnancy, desire to become pregnant during the study period, or currently breastfeeding
4. Known to have an allergy to ginger or had experienced adverse reactions to ginger previously
5. Underwent any major surgery within 6 months at the time of screening or planning to undergo a major surgery during the study period
6. Had any blood transfusion to replace blood lost due to surgery or injury within the last 6 months or need to receive a blood transfusion during the study period
7. Having underlying pathology and sources of overt and occult blood loss (e.g., GIT, genitourinary, nose, mouth, etc.) that was diagnosed or currently under investigation
8. Donating blood within 8 weeks of starting the trial or during the study period
9. Having underlying conditions due to chronic disease (e.g. inflammatory bowel disease, celiac disease, autoimmune gastritis, rheumatoid arthritis, etc.), liver disease, B12 deficiency, or malignancy
10. Having active infections or other medical conditions that elevate SF and high sensitivity C-reactive protein (hsCRP) acutely
11. Previous treatment of ID with oral iron therapy within the last 1 month or intravenous iron therapy within the last 3 months
12. Currently on warfarin or any other blood-thinning medications (anticoagulants)
13. No concurrently taking other dietary supplement of iron, vitamin C, probiotics, vitamin B12, folic acid, and vitamin D during the trial

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Serum Ferritin[ 0, 12, 24 weeks post-intervention commencement]

Secondary Outcome Measures

Name	Time	Method
Serum High Sensitive C-reactive Protein (hsCRP)[ 0, 12, 24 weeks post-intervention commencement];Erythrocyte Sedimentation Rate (ESR) performed on whole blood[ 0, 12, 24 weeks post-intervention commencement<br>];Serum Hepcidin[ 0, 12, 24 weeks post-intervention commencement<br>];Gastrointestinal Symptom Rating Scale (GSRS)[ 0, 12, 24 weeks post-intervention commencement]; Fatigue Severity Scale (FSS)[ 0, 12, 24 weeks post-intervention commencement];Changes in gut microbiota composition (alpha and beta diversity) based on the 16S rRNA sequencing using stool samples.[ 0, 12, 24 weeks post-intervention commencement]