Effects of rhLactoferrin on Chronic Inflammation in the Elderly (ELCIE)
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|ClinicalTrials.gov Identifier: NCT02968992|
Recruitment Status : Completed
First Posted : November 21, 2016
Results First Posted : March 26, 2020
Last Update Posted : March 26, 2020
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|Condition or disease||Intervention/treatment||Phase|
|Inflammation Cognitive Deterioration||Drug: rhLactoferrin Other: Placebo||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||36 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Care Provider, Investigator)|
|Masking Description:||•Randomized: Participants are assigned to intervention groups by chance|
|Official Title:||Effects of Lactoferrin on Chronic Inflammation in the Elderly|
|Actual Study Start Date :||August 14, 2017|
|Actual Primary Completion Date :||February 25, 2019|
|Actual Study Completion Date :||February 25, 2019|
rH lactoferrin will be provided by Ventria Biosciences. Each capsule will contain 250 mg of rH lactoferrin as active ingredient. Subjects will receive 1500 mg of lactoferrin in capsule form twice a day. Dosing will be six 250 mg capsules twice a day for six months.
Eligible participants will be provided with Recombinant Human lactoferrin (rhLF) in 250 mg capsules along with detailed instructions for taking the study drug and they will be asked to take six 250 mg capsules twice a day and to keep a daily dosing dairy.
Placebo Comparator: Placebo
Matching placebo capsule will be provided by Ventria Biosciences and six capsules twice a day will be provided to the subjects in this arm.
Eligible participant will be provided with placebo in capsules of 250 mg along with detailed instructions for taking the placebo. Participants will be asked to take six 250 mg capsules twice a day and to keep a daily dosing dairy.
- The Effect of Rhlactoferrin on Serum Levels of Interleukin-6 (IL-6) [ Time Frame: Baseline and 6 months ]The effect of rhlactoferrin on serum levels (picogram/milliliter) of Interleukin-6 (IL-6) will be assessed as a measure of the percentage change of IL-6 serum levels from baseline
- The Effect of Rhlactoferrin on Serum Levels of Tumor Necrosis Factor Alpha Receptor 1 (TNFR1) [ Time Frame: From baseline to 6 months ]The effect of rhlactoferrin on serum levels (picogram/milliliter) of tumor necrosis factor alpha receptor 1 (TNFR1) assessed as a measure of the percentage change of serum TNFR1 levels from baseline
- Attenuating Cognitive Decline as Measured by the Digital Symbol Substitution Test [ Time Frame: At 6 months ]The test taker is given a key consisting of numbers 1-9 that are paired with a unique symbol. The test taker is allowed 90 seconds to assign the correct symbol to the number on the list. The test administrator then scores the number of correct answers over the 90 second test time, and assigns a total score based on one point for each correct answer and therefore a higher score is a better outcome.
- Attenuating Cognitive Decline as Measured by the Trail Making Test A and B. [ Time Frame: At 6 months ]For test A, the test taker is given a sheet of paper that has the numbers 1-25 within individual circles randomly distributed on the page. The test taker is asked to connect the numbers sequentially over a period of 4 minutes (240 seconds). The score is recorded as the time it takes to complete the task in seconds. For test B, the test taker is given a piece of paper that has numbers 1-13 and letters A-L. Each letter or number is inside of a circle. The test taker must then draw a line from one circled number to the next circled letter (ie. 1 to A to 2 to B to 3 to C etc.) over a period of 6 minutes (360 seconds). The time it takes to complete this task is recorded in seconds.
- Physical Mobility as Measured by 4 Meter Walk Test [ Time Frame: At 6 months ]A standard measurement of 4 meters is marked on a flat, long floor surface. The test taker is asked to walk the length at their usual pace while the test giver is recording the time with a stop watch. This test is repeated twice, and the average of the two recorded times is used as the data point.
- Physical Mobility as Measured by 6 Minute Walk Test [ Time Frame: At 6 months ]A measured course is set up in an open area on a hard flat surface. The test taker walks on this measured course for 6 minutes, and the test administrators calculates the distance traveled over 6 minutes. The test taker is allowed to rest as is needed.
- Tolerability of Oral rhLactoferrin as Assessed by Patient Diary of Total Number of Side Effects [ Time Frame: From baseline through 6 months. ]Study coordinators administered side effect questionnaire at each visit and via phone every two weeks during the treatment period.
- Physical Strength as Measured by Grip Strength [ Time Frame: At 6 months ]Hand grip strength is measured by the amount of static force that the hand can squeeze around a dynamometer. An administrator recorded the reading on the device. The force was measured in kilograms.
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|Ages Eligible for Study:||70 Years and older (Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
- Age 70 and older
- able to complete 4- meter timed walk; walking speed <1.0 m/sec
- serum IL-6 level ≥ 2.5 pg/ml or TNFR1 level ≥1500 pg/ml
- Daily anti-inflammatory drug use (prednisone, Advil, Aleve, Remicade, Enbrel, methotrexate, standing nonsteroidal anti-inflammatory drugs (NSAID), aspirin greater than 325 mg per day)
- lower extremity mobility disability caused by Parkinson's disease,
- cerebral vascular accident (CVA) with residual motor deficit,
- severe osteoarthritis or rheumatoid arthritis
- symptomatic claudication
- hospitalization within 3 months for myocardial infarction (MI), angina, infection requiring antibiotics, or joint replacement.
- Mini-Mental State Examination (MMSE) < 21.
- Lactose intolerant
- allergy or intolerance to bovine products
- being a vegan (since vegans will want to avoid Bovine products.
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): NCT02968992
|United States, Maryland|
|Jeremy D. Walston|
|Baltimore, Maryland, United States, 21224|
|Principal Investigator:||Jerermy D. Walston, MD||Johns Hopkins Universtiy|
Documents provided by Johns Hopkins University:
|Responsible Party:||Johns Hopkins University|
|Other Study ID Numbers:||
|First Posted:||November 21, 2016 Key Record Dates|
|Results First Posted:||March 26, 2020|
|Last Update Posted:||March 26, 2020|
|Last Verified:||March 2020|
|Individual Participant Data (IPD) Sharing Statement:|
|Plan to Share IPD:||No|
|Studies a U.S. FDA-regulated Drug Product:||Yes|
|Studies a U.S. FDA-regulated Device Product:||No|