Ignite Creation Date:
2025-12-24 @ 2:14 PM
Ignite Modification Date:
2025-12-25 @ 3:31 PM
Study NCT ID:
NCT01171495
Status:
COMPLETED
Last Update Posted:
2010-07-28
First Post:
2010-07-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Impact of Nutrition Intervention on HIV/AIDS Infected Patients
Sponsor:
Caribbean Health Research Council
Organization:
Study Overview
Official Title:
Phase 3 Study That Assesses the Impact of a Nutrition Intervention on HIV/AIDS Infected Patients: Kingston, Jamaica
Status:
COMPLETED
Status Verified Date:
2010-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
INI
Brief Summary:
Intervention to investigate the efficacy of a nutritional supplement among ARV-naïve, asymptomatic HIV positive patients with a CD4 count in the range 300-550 cells/ul.
Detailed Description:
To investigate the efficacy of a nutritional supplement among ARV-naïve, asymptomatic HIV positive patients with a CD4 count in the range 300-550 cells/ul.
A total of 120 participants will be stratified by age and gender and randomly assigned to two treatment arms. Sixty (60) participants will be assigned to receive dietary counselling and a multivitamin/mineral supplement, with sixty (60) additionally receiving an oral Medical Nutritional Supplement (MNS).
Participants will be followed for six months post-randomization: at baseline, 3 months and 6 months. The principal outcome measure is Body Mass Index, used as a proxy for 'nutritional status'. Secondary outcome measures include immune status and antioxidant status.
A total of 120 participants will be stratified by age and gender and randomly assigned to two treatment arms. Sixty (60) participants will be assigned to receive dietary counselling and a multivitamin/mineral supplement, with sixty (60) additionally receiving an oral Medical Nutritional Supplement (MNS).
Participants will be followed for six months post-randomization: at baseline, 3 months and 6 months. The principal outcome measure is Body Mass Index, used as a proxy for 'nutritional status'. Secondary outcome measures include immune status and antioxidant status.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: