None listed
Conditions
Brief summary
This project aims to investigate whether taking ginger powder as a dietary supplement has any beneficial effect on blood ferritin levels in patients with iron deficiency (ID). The study will recruit 20 participants confirmed with an ID diagnosis attributable to dietary deficiency. Participants will be randomly assigned to either intervention or control groups. Participants in the intervention group will take three capsules of dried ginger powder (525 mg x3) per day in addition to oral iron therapy (standard care) during the trial. The control group will receive standard care only. Outcome measures include serum ferritin, haemoglobin, hepcidin, systemic inflammatory markers and patient-reported fatigue and indigestion scores. Data will be collected at baseline and 2 follow-up sessions 3 months apart.
Interventions
Oral supplement of dried ginger powder in 525 mg capsule 3 times per day as an adjunct to oral iron therapy (Ferrous Fumarate 200mg 2 tablets daily for 24 weeks) under standard care for 24 weeks. Adherence is self-report during the study visit.
Sponsors
The Oaks Medical Practice
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
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
Outcome results
None listed