Trial Outcomes & Findings for Evaluation of Natureheme-iron on Iron Absorption Effect and Anti-oxidation Functions (NCT NCT02871128)

NCT ID: NCT02871128

Last Updated: 2021-06-11

Results Overview

The Hb (g/dl) measure at baseline and 6 weeks and compare the value at 6 weeks minus value at baseline.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 60 participants
• Primary outcome timeframe: 6 weeks
• Results posted on: 2021-06-11

Participant Flow

Participant milestones

Measure	Natureheme-iron Subjects receive 2 capsules per day containing either 1000 mg Fe. Natureheme-iron: 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.	Placebo Subjects receive 2 capsules per day containing starch placebo of similar appearance. Placebo: 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.	Supplement Subjects receive 1 capsule per day containing either 100 mg Fe. supplement: 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.
Overall Study STARTED	20	20	16
Overall Study COMPLETED	20	19	15
Overall Study NOT COMPLETED	0	1	1

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Measure	Natureheme-iron n=20 Participants Subjects receive 2 capsules per day containing either 1000 mg Fe. Natureheme-iron: 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.	Placebo n=20 Participants Subjects receive 2 capsules per day containing starch placebo of similar appearance. Placebo: 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.	Supplement n=16 Participants Subjects receive 1 capsule per day containing either 100 mg Fe. supplement: 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.	Total n=56 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=20 Participants	0 Participants n=20 Participants	0 Participants n=16 Participants	0 Participants n=56 Participants
Age, Categorical Between 18 and 65 years	19 Participants n=20 Participants	19 Participants n=20 Participants	15 Participants n=16 Participants	53 Participants n=56 Participants
Age, Categorical >=65 years	1 Participants n=20 Participants	1 Participants n=20 Participants	1 Participants n=16 Participants	3 Participants n=56 Participants
Age, Continuous	42.70 years STANDARD_DEVIATION 11.90 • n=20 Participants	33.37 years STANDARD_DEVIATION 14.61 • n=20 Participants	43.40 years STANDARD_DEVIATION 15.29 • n=16 Participants	39.82 years STANDARD_DEVIATION 13.93 • n=56 Participants
Sex: Female, Male Female	2 Participants n=20 Participants	2 Participants n=20 Participants	1 Participants n=16 Participants	5 Participants n=56 Participants
Sex: Female, Male Male	18 Participants n=20 Participants	18 Participants n=20 Participants	15 Participants n=16 Participants	51 Participants n=56 Participants
Race and Ethnicity Not Collected	—	—	—	0 Participants Race and Ethnicity were not collected from any participant.
Region of Enrollment Taiwan	20 participants n=20 Participants	19 participants n=20 Participants	15 participants n=16 Participants	54 participants n=56 Participants

PRIMARY outcome

Timeframe: 6 weeks

The Hb (g/dl) measure at baseline and 6 weeks and compare the value at 6 weeks minus value at baseline.

Outcome measures

Measure	Natureheme-iron n=20 Participants Subjects receive 2 capsules per day containing either 1000 mg Fe. Natureheme-iron: 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.	Placebo n=19 Participants Subjects receive 2 capsules per day containing starch placebo of similar appearance. Placebo: 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.	Supplement n=15 Participants Subjects receive 1 capsule per day containing either 100 mg Fe. supplement: 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.
The Hemoglobin of the Subjects at Baseline and 6 Weeks	0.38 g/dl Standard Deviation 0.95	0.29 g/dl Standard Deviation 0.91	0.57 g/dl Standard Deviation 0.99

SECONDARY outcome

Timeframe: 6 weeks

values change of serum ferritin (ng/ml) between before to after 6 weeks

Outcome measures

Measure	Natureheme-iron n=20 Participants Subjects receive 2 capsules per day containing either 1000 mg Fe. Natureheme-iron: 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.	Placebo n=19 Participants Subjects receive 2 capsules per day containing starch placebo of similar appearance. Placebo: 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.	Supplement n=15 Participants Subjects receive 1 capsule per day containing either 100 mg Fe. supplement: 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.
The Changes of Serum Ferritin of the Subjects.	5.22 ng/ml Standard Deviation 91.7	-0.37 ng/ml Standard Deviation 43.98	11.86 ng/ml Standard Deviation 75.82

Adverse Events

Natureheme-iron

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Placebo

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Supplement

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. You-Cheng Shen

Chung Shan Medical University

Phone: +886-4-24730022

Email: youcheng@csmu.edu.tw

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place