Effects of rhLactoferrin on Chronic Inflammation in the Elderly (ELCIE)
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|ClinicalTrials.gov Identifier: NCT02968992|
Recruitment Status : Recruiting
First Posted : November 21, 2016
Last Update Posted : April 9, 2018
|Condition or disease||Intervention/treatment||Phase|
|Inflammation Cognitive Deterioration||Drug: rhLactoferrin Other: Placebo||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||60 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|
|Estimated Primary Completion Date :||February 2019|
|Estimated Study Completion Date :||February 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: up to 6 months ]The effect of rhlactoferrin on serum levels (picogram/milliliter) of Interleukin-6 (IL-6)
- The effect of rhlactoferrin on serum levels of tumor necrosis factor alpha receptor 1 (TNFR1) [ Time Frame: up to 6 months ]The effect of rhlactoferrin on serum levels (picogram/milliliter) of tumor necrosis factor alpha receptor 1 (TNFR1)
- Attenuating cognitive decline as measured by the digital symbol substitution test [ Time Frame: up to 6 months ]The test taker is given a key consisting of numbers 1-9 that are paired with a unique symbol. Below the key is a randomly generated list of the numbers repeated several times. 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.
- Attenuating cognitive decline as measured by the trail making test A and B. [ Time Frame: up to 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 record this task correctly is recorded in seconds.
- Physical mobility as measured by 4 meter walk test [ Time Frame: up to 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: up to 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 by patient diary [ Time Frame: up to 6 months. ]The subject will be given a calendar diary and will be asked to note any illnesses, especially related to gastrointestinal symptoms on the calendar with approximate time. This will be reviewed by study coordinator at least monthly.
- Adherence to oral rhLactoferrin by patient diary [ Time Frame: up to 6 months ]The participant will receive a calendar diary and will be asked to check off a box twice a day after they have taken their tablets.
- Adherence to oral rhLactoferrin by pill counts. [ Time Frame: up to 6 months ]The pharmacist will perform a pill count and document the count at monthly visits in order to further document compliance rates.
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
|Contact: Jeremy D. Walston, MDfirstname.lastname@example.org|
|Contact: Ora J White, BSemail@example.com|
|United States, Maryland|
|Jeremy D. Walston||Recruiting|
|Baltimore, Maryland, United States, 21224|
|Contact: Jeremy D. Walston, MD 410-550-2113 firstname.lastname@example.org|
|Contact: Ora J. White, BS 410-550-2113 email@example.com|
|Principal Investigator: Jeremy D. Walston, MD|
|Principal Investigator:||Jerermy D. Walston, MD||Johns Hopkins Universtiy|