Could Dietary Algae Affect Immunity and Viral Counts in People With HIV?

This study has been completed.
Sponsor:
Information provided by:
University of South Carolina
ClinicalTrials.gov Identifier:
NCT01195077
First received: September 2, 2010
Last updated: NA
Last verified: September 2010
History: No changes posted
  Purpose

Drawing inferences from epidemiologic studies of HIV/AIDS as well well as cell culture and animal studies of HIV inhibition by algae, we propose algal consumption as one unifying characteristic of countries with anomalously low rates. HIV/AIDS incidence and prevalence in Eastern Asia (<1/10,000 adults in Japan and Korea), compared to Africa (≈1/10 adults) strongly suggest that differences in IV drug use and sexual behavior are insufficient to explain the 1000-fold variation. Even in Africa, AIDS/HIV rates vary. Spirulina is part of the daily diet for many people living in Chad, where prevalence of HIV has remained at less than 4% for more than 20 years. Average daily algae consumption in Asia and Africa ranges between 1 to 2 tablespoons (3 - 13 grams).

HIV viral load is the main indicator of infection, however CD4 helper cell counts are most predictive of morbidity and mortality.We hypothesized that the consumption of algae could be important in diminishing the risk of HIV infection, and subsequent progression, possibly by enhancing the immune response.


Condition Intervention Phase
HIV Infections
Other: seaweed
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Single Blind (Subject)
Primary Purpose: Prevention
Official Title: Could Dietary Algae Affect Immunity and Viral Counts in People With HIV?

Resource links provided by NLM:


Further study details as provided by University of South Carolina:

Primary Outcome Measures:
  • Dietary algae influence on CD4 helper cells and HIV viral load [ Time Frame: Once a week for first 3 weeks, then once a month ] [ Designated as safety issue: Yes ]
    The first 6 subjects participated for 3 weeks. After analysis of the results, it was determined that there were no side effects and some indication of benefit. The next 6 subjects participated for up to 14 months.


Secondary Outcome Measures:
  • Would seaweed (Undaria) or spirulina or a combination of the two algae have more benefit? [ Time Frame: Participants were randomized to one of 3 treatments. ] [ Designated as safety issue: No ]
    The combination of the 2 algae appeared to have more benefit. However, the sample size was too small to make conclusions.


Enrollment: 12
Study Start Date: February 2003
Study Completion Date: June 2008
Primary Completion Date: June 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Seaweed, Spirulina, Both
Randomized to treatment
Other: seaweed
5 grams per day Undaria, spirulina, or both. Twice a day. Until left study

Detailed Description:

Twelve HIV+ patients not on antiretroviral therapy were clinically evaluated and enrolled in the three-week study. Subjects received 10 algae capsules/d. Laboratory tests of CD4 counts and HIV RNA were performed at baseline, week 1, week 2, and week 3, and then once a month. Six subjects continued for between 4 and 14 months. In addition to CD4 lymphocyte counts and viral loads, subjects were evaluated monthly for Complete Blood Counts (CBC), Liver profile, Basic Metabolic Panel, and some subjects were evaluated for thyroid function and cholesterol. All subjects completed standard HIV Quality of Life questionnaires at each clinic visit.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Clinical diagnosis of HIV
  • Able to swallow pills

Exclusion Criteria:

  • Allergy to iodine/seafood
  • Thyroid disease
  • Not taking antiretroviral therapy
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01195077

Locations
United States, South Carolina
Cancer Prevention and Control Program/University of South Carolina
Columbia, South Carolina, United States, 29208
Sponsors and Collaborators
University of South Carolina
  More Information

Publications:

Responsible Party: Jane Teas, University of South Carolina
ClinicalTrials.gov Identifier: NCT01195077     History of Changes
Other Study ID Numbers: Dietary Algae and HIV
Study First Received: September 2, 2010
Last Updated: September 2, 2010
Health Authority: United States: Institutional Review Board

Keywords provided by University of South Carolina:
HIV
Dietary intervention
Algae
HIV progression
Algae specific kind

Additional relevant MeSH terms:
HIV Infections
Acquired Immunodeficiency Syndrome
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Slow Virus Diseases

ClinicalTrials.gov processed this record on July 23, 2014