Research on the effect of UHA Gummy Supplement Iron intake on anemia symptoms (UHA-IRON-GS)

JRCT ID: jRCT1071230010

Registered date:19/04/2023

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: anaemia
• Date of first enrollment: 19/04/2023
• Target sample size: 150
• Study type: Interventional

Intervention(s)

1. UHA Gummy Supplement Iron (iron-containing gummy pills)
UHA Gummy Supplement Iron will be consumed daily after breakfast (or approximately at breakfast time if breakfast is not consumed) for 90 days.

2. Control food 1 (Iron-free gummy bear formulation)
Subject food 1 will be consumed after breakfast (or approximately at breakfast time if breakfast is not consumed) every day for 90 days.

3.Control food 2 (iron-containing tablets)
Subject food 2 will be taken with water or lukewarm water after breakfast (or approximately at breakfast time if breakfast is not consumed) every day for 90 days.

Outcome(s)

• Primary Outcome: Presence/frequency of iron-derived side effects (subjective evaluation)

Secondary Outcome

1. Rate of intake and continuation of research food
2. Hematology, blood biochemistry, and physiology tests
(serum iron, erythrocytes, hemoglobin, ferritin, total iron binding capacity, liver function values, etc.)
3. Quality of life
4. Other safety-related items(changes in laboratory values, adverse events, occurrence of side effects,etc.)

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: < 60age old
• Gender: Female

Include criteria

(1) Women between 20 and 60 years of age (full age at the time of consent)
(2) Hemoglobin level between 9 and 11.4g/dl
(3) Uncomplicated renal anemia, ferritin level of at least 100ng/dl , transferrin saturation of at least 20%, and serum iron of at least 40micro g/dl
(4) The subject has received a full explanation of the research, is able to understand the content, and is able to give written consent

Exclude criteria

(1) Those who are allergic to apple or gelatin
(2) Those with chronic anemia symptoms (gastrointestinal anemia, renal anemia, vitamin deficiency anemia after gastric cancer surgery, or other anemia-causing diseases, or those for whom the possibility of such anemia cannot be excluded)
(3) Persons who consume more than 60 grams of alcohol per day or regularly use more than 20 cigarettes per day
(4) Persons with an extremely irregular diet
(5) Those who regularly consume foods, beverages, or supplements that may be functional for iron intake
(6) Those who are resistant to blood sampling
(7) Those who have experienced difficulties with blood sampling at health checkups, etc.
(8) Those who are pregnant, lactating, or intend to become pregnant during this study period
(9) Who have been post-menopausal for more than 1 year
(10) Those who have been diagnosed with any disease that affects iron metabolism and are under treatment or medication
(11) Persons with serious life-threatening diseases
(12) Persons who are allergic to medicines or food
(13) Who is currently participating in a clinical research study of another drug or health food, and who plans to participate in another clinical research study within 4 weeks of the completion of the study or after consent to participate in such study
(14) Persons who have donated component blood or 200 mL of whole blood between 3 months before the start of the study and the previous month
(15) Persons who have donated 400 mL of whole blood from 3 months prior to the start of the study
(16) Persons whose total planned blood volume for the study exceeds 1200 mL when added to the blood collection volume from 3 months prior to the start of the study
(17) Persons who are judged by the principal investigator or sub-investigator to be inappropriate to participate in this study

Related Information

• Primary Sponsor: Takemoto Yuji
• Secondary Sponsor: UHA Mikakuto Co.,Ltd.