N/A N=56 Randomized Double-blind Prevention

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

Anemia

Bottom Line

View on ClinicalTrials.gov: NCT02871128 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Aug 2020

Primary outcome: Primary: The Hemoglobin of the Subjects at Baseline and 6 Weeks — 0.38; 0.29; 0.57 g/dl

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: Natureheme-iron (Dietary_supplement); Placebo (Dietary_supplement); supplement (Drug)
Age: Adult, Older Adult · 20+ yrs
Sex: All
Sponsor: Chung Shan Medical University
Primary completion: Sep 2016

Outcome Measures

Outcome	Result	p-value
PRIMARY The Hemoglobin of the Subjects at Baseline and 6 Weeks	0.38; 0.29; 0.57	—
SECONDARY The Changes of Serum Ferritin of the Subjects.	5.22; -0.37; 11.86	—

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.

Eligibility Criteria

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.

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Data sourced from ClinicalTrials.gov (NCT02871128). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.