The Role of Multivitamins in Pediatric HIV Management in Nigeria

NCT02552602 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 190

Last updated 2015-09-17

No results posted yet for this study

Summary

Micronutrient deficiencies in people living with HIV have been reported. Multivitamins can address micronutrient deficiencies, however the benefits of multivitamins in people living with HIV is still debatable. While some multivitamin intervention studies have reported the benefits of multivitamins in HIV infection, some other studies have reported no statistical differences in outcomes of interest in intervention and control groups. With clear differences in composition and strength of the multivitamins used in the different studies, it is possible that some of the multivitamins used in some of the intervention studies may have been unable to meet existing micronutrient deficiencies. Hence there is a chance that higher strength multivitamins may be better able to correct these deficiencies and result in better outcomes. This study will therefore compare three different multivitamins varying in strength and composition to determine if any one of the three multivitamins will produce better health outcomes.

Conditions

Interventions

DIETARY_SUPPLEMENT

Multivitamin A

Multivitamin containing 7 micronutrients at recommended daily allowance (RDA)

DIETARY_SUPPLEMENT

Multivitamin B

Multivitamin containing 22 micronutrients at RDA

DIETARY_SUPPLEMENT

Multivitamin C

Multivitamin containing 22 micronutrients at three times the RDA

Sponsors & Collaborators

  • University of the West of Scotland

    collaborator OTHER
  • Brunel Healthcare Manufacturing Limited

    collaborator UNKNOWN
  • Partec Nigeria

    collaborator UNKNOWN
  • Panets Education Trust for Africa (PETA)

    collaborator UNKNOWN
  • Lagos State University

    collaborator OTHER
  • Nigerian Institute of Medical Research

    collaborator OTHER_GOV
  • Scottish Trace Element and Micronutrient Diagnostic and Research Laboratory, Glasgow

    collaborator UNKNOWN
  • Regina Esiovwa

    lead OTHER

Principal Investigators

  • Regina Esiovwa · University of the West of Scotland

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
5 Years
Max Age
12 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-05-31
Primary Completion
2016-02-29
Completion
2016-02-29

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02552602 on ClinicalTrials.gov