Evaluation of Natureheme-iron on Iron Absorption Effect and Anti-oxidation Functions

Chung Shan Medical University

Status: Completed

Conditions: Anemia

Treatments: Drug: supplement; Dietary Supplement: Natureheme-iron; Dietary Supplement: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT02871128

CS14135

MOST 104-2622-E-040-002 -CC2 (Other Grant/Funding Number)

Details and patient eligibility

About

Iron deficiency problem has always been in Taiwan. This is a randomized, double-blind trial. Subjects separate to 3 groups, one group (n = 20) take two Natureheme-iron capsules a day for a total of 12 weeks, another group (n = 20) with the same dose of placebo, and the other group (n = 20) is a commercial iron supplement. Investigators assess whether Natureheme-iron can promote iron absorption and antioxidant effects, and compare the effects with commercial iron supplement. When this study is completed, it will increase the value of Natureheme-iron, and can improve health of Taiwanese.

Full description

FAO / WHO noted that iron deficiency is still an important nutritional problem. Iron deficiency problem has always been in Taiwan. This study intends to use the products, Natureheme-iron, using blood of pig to concentration, separation and extracted, and then got natural and clean Natureheme-iron. Natureheme-iron is not just a good iron supplement, while also providing an excellent source of natural protein. This is a randomized, double-blind trial, subjects separate to 3 groups, one group (n = 20) take two Natureheme-iron capsules a day for a total of 12 weeks (1000mg Fe / capsule), another group (n = 20) with the same dose of placebo, and the other group (n = 20) is a commercial iron supplement (100mg Fe). Investigators assess whether Natureheme-iron can promote iron absorption and antioxidant effects, and compare the effects with commercial iron supplement. When this study is completed, it will increase the value of Natureheme-iron, and can improve health of Taiwanese.

Enrollment: 60 patients

Sex: All

Ages: 20+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Eligible subjects were anemia men or women aged over 20 years old with Hb<=12 g/dl.

Exclusion criteria

• Subjects were excluded if subjects had a history of major cardiovascular disease, severe liver dysfunction, insulin-dependent diabetes mellitus or stroke. Subjects were also excluded if they routinely consumed alcohol, were pregnant or unable to comprehend study instructions.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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60 participants in 3 patient groups, including a placebo group

Natureheme-iron

Experimental group

Description:

Subjects receive 2 capsules per day containing either 1000 mg Fe.

Treatment:

Dietary Supplement: Natureheme-iron

Placebo

Placebo Comparator group

Description:

Subjects receive 2 capsules per day containing starch placebo of similar appearance.

Treatment:

Dietary Supplement: Placebo

supplement

Active Comparator group

Description:

Subjects receive 1 capsule per day containing either 100 mg Fe.

Treatment:

Drug: supplement