How Does a Synbiotic Supplement Affect Iron Status During Iron Repletion in Iron Depleted Female Athletes?
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|ClinicalTrials.gov Identifier: NCT03793959|
Recruitment Status : Completed
First Posted : January 4, 2019
Last Update Posted : January 4, 2019
|Condition or disease||Intervention/treatment||Phase|
|Iron-deficiency||Dietary Supplement: Synbiotic Supplement Dietary Supplement: Placebo||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||20 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||Twenty eligible athletes (baseline Hgb:12.3±0.9g/dL; sFer:18.1±9.2µg/L) were then randomized to receive either a daily synbiotic supplement (5g prebiotic fiber + 8 billion CFU probiotic B. lactis) or placebo, along with a daily Fe supplement (140 mg FeSO4/d) for 8 weeks using a double-blind design.|
|Masking:||Triple (Participant, Investigator, Outcomes Assessor)|
|Official Title:||How Does a Synbiotic Supplement Affect Iron Status During Iron Repletion in Iron Depleted Female Athletes?|
|Actual Study Start Date :||August 28, 2016|
|Actual Primary Completion Date :||December 8, 2017|
|Actual Study Completion Date :||December 8, 2017|
Experimental: Synbiotic Supplement
Daily synbiotic supplement (5g prebiotic fiber + 8 billion CFU probiotic B. lactis, identical to Placebo-- white powder), along with a daily Fe supplement (140 mg FeSO4/d) for 8 weeks.
Dietary Supplement: Synbiotic Supplement
Other Name: Regular Girl
Placebo Comparator: Placebo Supplement
Daily placebo supplement (5g maltodextrin, identical to Experimental -- white powder), along with a daily Fe supplement (140 mg FeSO4/d) for 8 weeks.
Dietary Supplement: Placebo
- Iron status [ Time Frame: 8 weeks ]Change in serum ferritin
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03793959
|United States, Pennsylvania|
|Scranton, Pennsylvania, United States, 18509|