NCT00838292

Brief Summary

The purpose of the study is to test whether food supplementation of malnourished HIV-infected adults (both pre-ART and ART) in resource constrained settings improves their nutritional status, clinical status, effectiveness of treatment, quality of life, functioning, and survival.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,049

participants targeted

Target at P75+ for not_applicable hiv

Timeline
Completed

Started Aug 2006

Geographic Reach
1 country

6 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2006

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2008

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

February 3, 2009

Completed
3 days until next milestone

First Posted

Study publicly available on registry

February 6, 2009

Completed
Last Updated

March 13, 2009

Status Verified

February 1, 2009

Enrollment Period

1.8 years

First QC Date

February 3, 2009

Last Update Submit

March 12, 2009

Conditions

HIVMalnutritionHIV Infections

Keywords

food supplementationHIVmalnutrition

Outcome Measures

Primary Outcomes (1)

  • Body Mass Index

    monthly

Secondary Outcomes (3)

  • CD4 counts

    every three months (quarterly)

  • Quality of Life

    monthly

  • drug adherence

    monthly

Study Arms (4)

ART: food

ACTIVE COMPARATOR

ART + food supplementation + nutrition counseling

Dietary Supplement: fortified blended flour - Insta Foundation Plus (with whey protein concentrate)Other: nutrition counseling

ART: no food

ACTIVE COMPARATOR

ART + nutrition counseling

Other: nutrition counseling

pre-ART: food

ACTIVE COMPARATOR

no ART (cotrimoxazole provided) + food supplementation + nutrition counseling

Dietary Supplement: fortified blended flour - Insta Foundation Plus (with whey protein concentrate)Other: nutrition counseling

pre-ART: no food

ACTIVE COMPARATOR

no ART (cotrimoxazole provided) + nutrition counseling

Other: nutrition counseling

Interventions

fortified blended flour - Insta Foundation Plus (with whey protein concentrate)DIETARY_SUPPLEMENT

300 grams/day for 6 months

Also known as: Insta Products Ltd. Foundation Plus product with whey protein concentrate.
ART: foodpre-ART: food
nutrition counselingOTHER
ART: foodART: no foodpre-ART: foodpre-ART: no food

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • HIV-infected
  • BMI \< 18.5
  • Resident of area for past 6 months

You may not qualify if:

  • Pregnant or lactating (child \< 6 months)
  • BMI \> 18.5, BMI \< 14
  • Already receiving other food supplements

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (6)

Maragwa District Hospital

Maragwa, Kenya

Location

Mathere North Hospital

Nairobi, Kenya

Location

Mbagathi District Hospital

Nairobi, Kenya

Location

Riruta City Council Hospital

Nairobi, Kenya

Location

Naivasha District Hospital

Naivasha, Kenya

Location

Nyeri Provincial Hospital

Nyeri, Kenya

Location

MeSH Terms

Conditions

MalnutritionHIV Infections

Interventions

Pharmaceutical PreparationsWhey

Condition Hierarchy (Ancestors)

Nutrition DisordersNutritional and Metabolic DiseasesBlood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System Diseases

Intervention Hierarchy (Ancestors)

MilkBeveragesDiet, Food, and NutritionPhysiological PhenomenaDairy ProductsFoodFood and Beverages

Study Officials

  • James Muttunga, Ph.D.

    Kenya Medical Research Institute

    PRINCIPAL INVESTIGATOR

  • Robert Mwadime, Ph.D.

    Academy for Educational Development, FANTA Project

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

February 3, 2009

First Posted

February 6, 2009

Study Start

August 1, 2006

Primary Completion

June 1, 2008

Study Completion

June 1, 2008

Last Updated

March 13, 2009

Record last verified: 2009-02

Locations

KE(6)