Clinical trial NCT02871128
Conditions: Anemia
Keywords: Hemoglobin serum iron serum ferritin Hematocrit antioxidant
Sponsor: Chung Shan Medical University
Start date: 2015-07-01; Completion date: 2016-12-01
Enrollment: 60 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
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.

Detailed 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.

Arms: arm 1: Subjects receive 2 capsules per day containing either 1000 mg Fe. arm 2: Subjects receive 2 capsules per day containing starch placebo of similar appearance. arm 3: Subjects receive 1 capsule per day containing either 100 mg Fe.
Interventions: intervention 1: Natureheme-iron intervention 2: Placebo intervention 3: supplement
Intervention descriptions: intervention 1: An 12 week double-blinded randomized parallel study with 4 week follow-up period was performed in mild anemia subjects. Consenting eligible subjects were receive 2 capsules per day containing either 1000 mg Fe of similar appearance for 12 weeks. The subjects were required to visit at baseline, every 6 weeks during the intervention period (6 weeks), and at follow-up 4 weeks after treatment had ended. During each study visit, fasting blood samples were collected and anthropometric measurements were performed. Compliance was evaluated using a food diary and monitored with biweekly telephone calls. intervention 2: An 12 week double-blinded randomized parallel study with 4 week follow-up period was performed in mild anemia subjects. Consenting eligible subjects were receive 2 capsules per day containing either 1000 mg starch placebo of similar appearance for 12 weeks. The subjects were required to visit at baseline, every 6 weeks during the intervention period (6 weeks), and at follow-up 4 weeks after treatment had ended. During each study visit, fasting blood samples were collected and anthropometric measurements were performed. Compliance was evaluated using a food diary and monitored with biweekly telephone calls. intervention 3: An 12 week double-blinded randomized parallel study with 4 week follow-up period was performed in mild anemia subjects. Consenting eligible subjects were receive 1 capsule per day containing either 100 mg Fe of similar appearance for 12 weeks. The subjects were required to visit at baseline, every 6 weeks during the intervention period (6 weeks), and at follow-up 4 weeks after treatment had ended. During each study visit, fasting blood samples were collected and anthropometric measurements were performed. Compliance was evaluated using a food diary and monitored with biweekly telephone calls.

Protocol documents: