Anemia
Conditions
Keywords
Hemoglobin, serum iron, serum ferritin, Hematocrit, antioxidant
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.
Interventions
DIETARY_SUPPLEMENTNatureheme-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.
DIETARY_SUPPLEMENTPlacebo
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.
DRUGsupplement
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.
Sponsors
Chung Shan Medical University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
20 Years to No maximum
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The Hemoglobin of the Subjects at Baseline and 6 Weeks | 6 weeks | The Hb (g/dl) measure at baseline and 6 weeks and compare the value at 6 weeks minus value at baseline. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The Changes of Serum Ferritin of the Subjects. | 6 weeks | values change of serum ferritin (ng/ml) between before to after 6 weeks |
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 20 |
| 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. | 20 |
| 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. | 16 |
| Total | 56 |
Baseline characteristics
| Characteristic | Placebo | Supplement | Natureheme-iron | Total |
|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 1 Participants | 1 Participants | 1 Participants | 3 Participants |
| Age, Categorical Between 18 and 65 years | 19 Participants | 15 Participants | 19 Participants | 53 Participants |
| Age, Continuous | 33.37 years STANDARD_DEVIATION 14.61 | 43.40 years STANDARD_DEVIATION 15.29 | 42.70 years STANDARD_DEVIATION 11.9 | 39.82 years STANDARD_DEVIATION 13.93 |
| Race and Ethnicity Not Collected | — | — | — | 0 Participants |
| Region of Enrollment Taiwan | 19 participants | 15 participants | 20 participants | 54 participants |
| Sex: Female, Male Female | 2 Participants | 1 Participants | 2 Participants | 5 Participants |
| Sex: Female, Male Male | 18 Participants | 15 Participants | 18 Participants | 51 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 20 | 0 / 19 | 0 / 15 |
| other Total, other adverse events | 0 / 20 | 0 / 19 | 0 / 15 |
| serious Total, serious adverse events | 0 / 20 | 0 / 19 | 0 / 15 |
Outcome results
Primary
The Hemoglobin of the Subjects at Baseline and 6 Weeks
The Hb (g/dl) measure at baseline and 6 weeks and compare the value at 6 weeks minus value at baseline.
Time frame: 6 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Natureheme-iron | The Hemoglobin of the Subjects at Baseline and 6 Weeks | 0.38 g/dl | Standard Deviation 0.95 |
| Placebo | The Hemoglobin of the Subjects at Baseline and 6 Weeks | 0.29 g/dl | Standard Deviation 0.91 |
| Supplement | The Hemoglobin of the Subjects at Baseline and 6 Weeks | 0.57 g/dl | Standard Deviation 0.99 |
Secondary
The Changes of Serum Ferritin of the Subjects.
values change of serum ferritin (ng/ml) between before to after 6 weeks
Time frame: 6 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Natureheme-iron | The Changes of Serum Ferritin of the Subjects. | 5.22 ng/ml | Standard Deviation 91.7 |
| Placebo | The Changes of Serum Ferritin of the Subjects. | -0.37 ng/ml | Standard Deviation 43.98 |
| Supplement | The Changes of Serum Ferritin of the Subjects. | 11.86 ng/ml | Standard Deviation 75.82 |