The Role of Multivitamins in Pediatric HIV Management in Nigeria

September 16, 2015 updated by: Regina Esiovwa

The Role of Multivitamins in Pediatric HIV Management in Nigeria: A Randomized Controlled Study

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

The link between micronutrient deficiencies and advanced HIV disease has been reported. Micronutrient deficiencies in people living with HIV/AIDS (PLWHA) have been linked to reduced antioxidant levels and oxidative stress. In turn oxidative stress is believed to promote HIV disease progression. The use of multivitamins in PLWHA therefore has the potential to cut off the interconnections between micronutrient deficiencies and HIV disease progression. If beneficial, multivitamin use in PLWHA could result in improved health outcomes.

A number of studies have explored this possibility with different results. Differences in multivitamin strength and composition could have been responsible for the different results. Therefore, it is likely that increasing the strength and composition of the intervention multivitamin could possibly produce a single result of improved health outcomes across board. Hence this study will determine if multivitamins at higher strength can cause better health outcomes in study participants compared to lower strength multivitamins.

Multivitamin A is composed of 7 vitamins at recommended daily allowance (RDA), multivitamin B is made up of 22 micronutrients at RDA and multivitamin C is made up of 22 micronutrients at 3 times the RDA. These multivitamins were administered to the 190 study participants in a double blind randomized controlled study to determine if there would be any significant differences in health outcome of participants after 6 months of multivitamin use. All multivitamins regardless of their composition were manufactured to look identical and packaged in identical containers.

This double blind randomized controlled study is being conducted at the HIV treatment centers of the Nigerian Institute of Medical Research and the Lagos State University Teaching Hospital, both in Lagos Nigeria. At the design stage of the study, a feasibility study was carried out at both HIV treatment centers to assess the practicability and potential of success for this study. Following a successful feasibility study, ethical approval was applied for and obtained from each institution.

Study Type

Interventional

Enrollment (Actual)

190

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

5 years to 12 years (CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Children aged 5 - 12 years attending the outpatient clinic of the two HIV treatment centers who have tested positive to HIV
  2. Children who can return for follow up during the 6 months of the study
  3. Children with guardians who can give informed consent -

Exclusion Criteria:

  1. Children enrolled in other studies
  2. Guardians and children anticipating moving away from the study state

  3. Children receiving immunosuppressive therapy

    -

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: SUPPORTIVE_CARE
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: QUADRUPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: Group A
Study participants in this arm will be given Multivitamin A
Dietary supplement: Multivitamin A
Multivitamin containing 7 micronutrients at recommended daily allowance (RDA)
ACTIVE_COMPARATOR: Group B
Study participants in this arm will be given Multivitamin B
Dietary supplement: Multivitamin B
Multivitamin containing 22 micronutrients at RDA
ACTIVE_COMPARATOR: Group C
Study participants in this arm will be given Multivitamin C
Dietary supplement: Multivitamin C
Multivitamin containing 22 micronutrients at three times the RDA

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
CD4 count
Time Frame: 6 months
A measure of immune competence. CD4 count could range from 500-1500 cells/mm3. Lower values can be seen with advancing HIV disease
6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Serum selenium levels
Time Frame: 6 months
To measure selenium deficiency. Range of 70µg/L -100µg/L have been proposed to describe adequacy of selenium levels in serum.
6 months
Serum zinc levels
Time Frame: 6 months
To determine levels of zinc deficiency. 80µg/dL is often used as a cutoff point to signify deficiency in serum
6 months
Serum vitamin A levels
Time Frame: 6 months
To determine vitamin A deficiency using cut off point of 0.7µmol/L for participants 5-6 years and 0.9µmol/L for participants 7-12 years
6 months
Red cell vitamin B6 levels
Time Frame: 6 months
To identify B6 deficiency. 250-680 pmol/g haemoglobin will be the reference range used
6 months
Serum Copper levels
Time Frame: 6 months
To evaluate copper deficiency. 12.5 to 22μmol/L will be the reference range used
6 months
Red cell manganese levels
Time Frame: 6 months
To determine deficiency. Reference range not yet established
6 months
Red cell Magnesium
Time Frame: 6 months
To determine deficiency levels. Reference range of 5.80-8.55 μmol/g haemoglobin will be used
6 months
Serum vitamin E levels
Time Frame: 6 months
To determine deficiency. Reference range of 3.5 - 9.5 μmol/mmol cholesterol will be used
6 months
Red cell selenium levels
Time Frame: 6 months
To measure selenium deficiency.3.6 - 10.6 nmol/g haemoglobin will be the reference range used
6 months
Red cell zinc levels
Time Frame: 6 months
To determine zinc deficiency. 423-781 nmol/g haemoglobin will be the reference range used
6 months
Red cell Copper levels
Time Frame: 6 months
To evaluate copper deficiency. 27.9-53.4 nmol/g haemoglobin will be the reference range used
6 months

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Hemoglobin (g/dl)
Time Frame: 6 months
As part of routine tests
6 months
Serum Alanine aminotransferase (ALT) levels (U/L)
Time Frame: 6 months
As part of routine tests
6 months
Serum Aspartate aminotransferase (AST) levels (IU/L)
Time Frame: 6 months
As part of routine tests
6 months
Serum Bilirubin levels (mg/dl)
Time Frame: 6 months
As part of routine tests
6 months
Serum Albumin levels (g/dl)
Time Frame: 6 months
As part of routine tests
6 months
Serum Creatinine levels (mg/dl)
Time Frame: 6 months
As part of routine tests
6 months
Serum Urea levels (mg/dl)
Time Frame: 6 months
As part of routine tests
6 months
Serum C- Reactive Protein levels (mg/L)
Time Frame: 6 months
As part of routine tests
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Regina Esiovwa

Collaborators

Lagos State University
Nigerian Institute of Medical Research
University of the West of Scotland
Brunel Healthcare Manufacturing Limited
Partec Nigeria
Panets Education Trust for Africa (PETA)
Scottish Trace Element and Micronutrient Diagnostic and Research Laboratory, Glasgow

Investigators

  • Principal Investigator: Regina Esiovwa, University of the West of Scotland

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2015

Primary Completion (ANTICIPATED)

February 1, 2016

Study Completion (ANTICIPATED)

February 1, 2016

Study Registration Dates

First Submitted

September 9, 2015

First Submitted That Met QC Criteria

September 16, 2015

First Posted (ESTIMATE)

September 17, 2015

Study Record Updates

Last Update Posted (ESTIMATE)

September 17, 2015

Last Update Submitted That Met QC Criteria

September 16, 2015

Last Verified

September 1, 2015

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • REGPHD2015

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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