NCT02433743

Brief Summary

A clinical trial was conducted in 65 PLWH randomly allocated to receive standard hospital diet alone (Control group: n=33), or the diet combined with 100 g/day of RUTF (RUTF group: n=32). Individual dietary intakes were measured and compared to the Recommended Dietary Allowances (RDA) for PLWH. Body composition was measured by bio-impedance analysis (BIA), hemoglobin by HemoCue and plasma zinc concentration by atomic absorption spectrometry and adjusted to infection (CRP and α1-AGP). All measures were conducted at baseline, 3 weeks and after 9 weeks home-based follow up.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
65

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Oct 2011

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2011

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2012

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2012

Completed
2.8 years until next milestone

First Submitted

Initial submission to the registry

April 18, 2015

Completed
17 days until next milestone

First Posted

Study publicly available on registry

May 5, 2015

Completed
Last Updated

May 5, 2015

Status Verified

April 1, 2015

Enrollment Period

8 months

First QC Date

April 18, 2015

Last Update Submit

April 29, 2015

Conditions

HIV-infection/AidsMalnutrition

Keywords

HIV/AIDSRUTFfat free massanemiazincSenegal

Outcome Measures

Primary Outcomes (1)

  • Change from baseline in body composition at 9 weeks

    Body composition was measured using Bio-impedance analysis method at baseline, and 9 weeks home-based follow-up in both supplemented and control groups

    9 weeks

Secondary Outcomes (4)

  • Change from baseline on anemia at 3 weeks

    3 weeks

  • Change from baseline on anemia at 9 weeks

    9 weeks

  • Change from baseline on plasma zinc concentration at 3 weeks

    3 weeks

  • Change from baseline on plasma zinc concentration at 9 weeks

    9 weeks

Study Arms (2)

Control

NO INTERVENTION

Control group (n=33) didn't received intervention. The received the standard hospital diet

Ready-to-use therapeutic food (RUTF)

EXPERIMENTAL

RUTF group (n=32) received the standard hospital diet combined with 100 g/day of RUTF

Dietary Supplement: Ready-to-use therapeutic food (RUTF)

Interventions

Ready-to-use therapeutic food (RUTF)DIETARY_SUPPLEMENT

HIV-infected patients were randomly allocated to receive standard hospital diet (Control: n=33), or this diet combined with 100 g/day of RUTF (RUTF: n=32). All patients was follow-up during hospitalisation and 9 week after discharge at home

Also known as: RUTF
Ready-to-use therapeutic food (RUTF)

Eligibility Criteria

Age18 Years - 78 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • HIV/AIDS men and women
  • at any WHO stages of HIV disease,
  • under ART treatment or not,
  • without psychiatric illness and not diabetic

You may not qualify if:

  • confirmed HIV-negative,
  • long term physical disability
  • inability to eat

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Cheikh Anta Diop

Dakar, Senegal

Location

Related Publications (1)

  • Diouf A, Badiane A, Manga NM, Idohou-Dossou N, Sow PS, Wade S. Daily consumption of ready-to-use peanut-based therapeutic food increased fat free mass, improved anemic status but has no impact on the zinc status of people living with HIV/AIDS: a randomized controlled trial. BMC Public Health. 2016 Jan 4;16:1. doi: 10.1186/s12889-015-2639-8.

    PMID: 26728978DERIVED

MeSH Terms

Conditions

Acquired Immunodeficiency SyndromeMalnutritionAnemia

Condition Hierarchy (Ancestors)

HIV InfectionsBlood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesSlow Virus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System DiseasesNutrition DisordersNutritional and Metabolic DiseasesHematologic DiseasesHemic and Lymphatic Diseases

Study Officials

  • Salimata Wade, Professor

    Université Cheikh Anta Diop de Dakar

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Adama Diouf

Study Record Dates

First Submitted

April 18, 2015

First Posted

May 5, 2015

Study Start

October 1, 2011

Primary Completion

June 1, 2012

Study Completion

July 1, 2012

Last Updated

May 5, 2015

Record last verified: 2015-04

Locations

SE(1)