Clinical Trials

Dr. Foster used his nutrient formulations in several studies and one major trial, which demonstrated significant improvements in the metabolic deficiencies associated with the distinctive nutritional requirements of PLWHA.

Mengo Hospital Trial (Read Full Published Article)

Double-blind, randomized, controlled clinical study for 52 weeks with 310 HIV-seropositive patients with baseline CD4 counts above 200, who were not receiving antiretroviral drugs.

Primary endpoints: 

  • Mean/median serum glutathione peroxidase levels rose significantly (p<0.000) by a factor of approximately 2.5. Such increases are unexpected in HIV-positive patients who are not receiving ARVs, since serum selenium and glutathione peroxidase levels both decline as HIV/AIDS progresses.

GPx Trial Graph

  • CD4 cell counts rose significantly, indicative of an improving immune system. The typical CD4 count for a healthy individual is between 500-1500 cells/ml2.2 In HIV-positive patients not receiving ARVs, the CD4 count decreases on average between 50 to 100 cells/year. Mean and median CD4 cell counts were approximately 120 cells/ml2 of blood higher than expected in HIV-positive patients not receiving antiretrovirals. 

CD4 Trial Graph

 Secondary endpoints:

  • General health status as measured by Karnofsky scores3 increased significantly (p<0.01). Patients reported that their appetite had increased, together with the return of their ability to walk long distances and most reported being happier, indicating a general improvement in health
  • Weight gain

Follow-up assessment 6 months after stopping treatment – Kampala, Uganda  (Read Report for More Information)

Six months after the formal closed trial had ended and nutrient supplementation ceased, the mean/medium serum glutathione peroxidase levels and CD4 counts of assessed patients had fallen dramatically (p<0.001). In addition, weight and the Karnofsky quality of life scores had fallen significantly (p<0.001).4

Such declines had occurred because HIV in all patients started to replicate rapidly. These dramatic drops more than negated all the gains in the general health status that the patients had achieved during the nutritional clinical study.

Other Open Studies Conducted

Trial

Location

Date

Patients

Results

Initial Trial

 Sparrow Village, Maraisburg, Roodepoort, South Africa January 2004 6 hospice patients 5 Greatly Improved

Quality of Life Trial

 Mengo Hospital, Kampala Uganda July-August 2004 40 patients (7 also had TB and 4 had syphilis) 30 Greatly Improved after 1 month

Child Care and Adoption Society Trial

 Lusaka, Zambia October 2005 15 patients (4 on ARVs, 7 with TB) All 15 improved in first month (most improved in first 2 weeks)

Bradfield Study

 Private Residence, South Africa October 2006 6 family employees with AIDS All 6 improved


Sources:
  1. Namulema E, Sparling, J & Foster, HD. Nutritional supplements can delay the progression of AIDS in HIV-infected patients: results from a double-blinded clinical trial at Mengo Hospital, Kampala, Uganda. J. Orthomol. Med., 2007. 22(3):129-36.
  2. AIDS Meds. Com T-cell Test. http://www.aidsmeds.com/articles/TCellTest_4727.shtml
  3. The Measurement Group.com. Definition: Karnofsky Severity Rating. http://www.themeasurementgroup.com/definitions/karnofsky.htm
  4. Namulema, E, Sparling J, Foster HD. When the nutritional supplements stop: Evidence from a double-blinded, HIV clinical trial at Mengo Hospital, Kampala, Uganda. 2008. J. Orthomol Med, 23(3):130-2.