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Effects of Docosahexanoic Acid on Neurocognitive Impairment in HIV-infected Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04242004
Recruitment Status : Active, not recruiting
First Posted : January 27, 2020
Last Update Posted : January 27, 2020
Sponsor:
Information provided by (Responsible Party):
Fudan University

Brief Summary:
Neurocognitive impairment (NCI) is one of the serious complications of elderly HIV-infected patients. The destruction of intestinal mucosal barrier and imbalance of bacterial flora caused by aging and HIV infection may be an important factor promoting the occurrence of NCI. Therefore, it is important to understand changes in gut microbiota of HIV-infected patients with NCI. Higher dietary intake of the essential fatty acid docosahexaenoic (DHA) has been associated with better cognitive performance in several epidemiological studies. To date, data are limited showing that DHA administration leads to benefits for behavioral disorders by modulating gut microbiota composition; the few studies on this subject, mostly completed in animal models. Moreover,low levels of DHA have been found in HIV-infected patients. The effect of DHA supplementation on gut microbiota and NCI status of HIV-positive patients have not been evaluated yet. Investigators aim to implement a case-control study to identify the relationship between gut microbiota and NCI in HIV-infected patients. At the meantime, investigators aim to implement a randomized, double-blind, placebo-controlled clinical trial to assess DHA supplementation in HIV-infected patients with NCI for 16 weeks. The effect of DHA on gut microbiota and NCI were evaluated. Also, investigators aim to identify if the benefits for NCI of DHA caused by modulating gut microbiota composition and metabolites.

Condition or disease Intervention/treatment Phase
Neurocognitive Impairment Drug: Docosahexaenoic acid (DHA) capsules Dietary Supplement: Soy oil capsules Phase 1 Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 88 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Randomization (1:1) was performed according to a computer-generated random sequence, which was used to allocate the participants either to the dietary supplement or the placebo group.
Masking: Double (Participant, Investigator)
Masking Description: Participants, and investigators assessing outcome measures were blind to the intervention condition. Blinding was maintained until data analysis was completed.
Primary Purpose: Treatment
Official Title: Effects of Docosahexanoic Acid on Neurocognitive Impairment in HIV-infected Patients: A Randomized, Double-blind, Placebo-controlled Study
Actual Study Start Date : October 30, 2019
Estimated Primary Completion Date : March 1, 2020
Estimated Study Completion Date : May 1, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS

Arm Intervention/treatment
Experimental: DHA group Drug: Docosahexaenoic acid (DHA) capsules
Treatment was provided as 7 omega-3 fatty acid (Lovaza) capsules daily. Each capsule contained 1 g of omega-3 fatty acids with approximately 450 mg of docosahexaenoic acid (DHA).

Placebo Comparator: placebo group Dietary Supplement: Soy oil capsules
The placebo was identical looking capsules that contained soy oil




Primary Outcome Measures :
  1. Neurocognitive impairment [ Time Frame: 16 weeks ]
    Participants underwent neurocognitive testing using an internationally validated comprehensive neurocognitive test battery covering 7 cognitive domains: verbal fluency, speed of information processing, executive functioning, learning, memory, attention/working memory and motor skills. Demographically-corrected (age, education, gender) T scores (mean of 50, standard deviation of 10) were developed based upon an age-matched control group. Individual test deficit scores, determined via demographically-adjusted T scores, ranged from 0 (T score of > 40) to 5 (T score < 20). Neurocognitive impairment (NCI) was assessed using the global deficit score (GDS), calculated as the average of deficit scores across all neuropsychological test. The cut-off for NCI was a GDS score ≥ 0.5

  2. Gut microbiota [ Time Frame: 16 weeks ]
    Investigators characterized the 16S rDNA fecal microbiome in participants. Shannon diversity index (SDI) was used to evaluate alpha (within sample) diversity. Beta (between sample) diversity was examined using principle coordinate analysis (PCoA) of unweighted Unifrac distances. Relative abundance of microbial taxa was compared between samples using Linear Discriminant Analysis Effect Size (LEfSe)



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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Male and female patients
  • Age ≥18 years
  • Established diagnosis of HIV-1 infection, under stable cART for the prior 6 months and throughout the study period
  • Presence of neurocognitive impairment was assessed using the global deficit score (GDS), calculated as the average of deficit scores across all neuropsychological test. The cut-off for NCI was a GDS score ≥ 0.5

Exclusion Criteria:

  • Age <18 years,
  • BMI >30 kg/m2
  • Pregnancy or lactation
  • A history of diabetes mellitus, cardiovascular and cerebrovascular diseases, or serious diseases such as liver, kidney and hematopoietic system disease
  • Known intolerance to n-3 PUFA preparations.

Information from the National Library of Medicine

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): NCT04242004


Locations
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China, Shanghai
Department of epidemiology, School of public health, Fudan University,
Shanghai, Shanghai, China, 200000
Sponsors and Collaborators
Fudan University
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Responsible Party: Fudan University
ClinicalTrials.gov Identifier: NCT04242004    
Other Study ID Numbers: IRB#2019-06-0759
First Posted: January 27, 2020    Key Record Dates
Last Update Posted: January 27, 2020
Last Verified: January 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Fudan University:
HIV-infected patients
neurocognitive impairment
gut microbiota
fatty acid docosahexaenoic
randomized controlled trial