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The Role of Multivitamins in Pediatric HIV Management in Nigeria

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02552602
Enrollment
190
Registered
2015-09-17
Start date
2015-05-31
Completion date
2016-02-29
Last updated
2015-09-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

HIV

Keywords

HIV, Multivitamins

Brief 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.

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.

Interventions

DIETARY_SUPPLEMENTMultivitamin A

Multivitamin containing 7 micronutrients at recommended daily allowance (RDA)

DIETARY_SUPPLEMENTMultivitamin B

Multivitamin containing 22 micronutrients at RDA

DIETARY_SUPPLEMENTMultivitamin C

Multivitamin containing 22 micronutrients at three times the RDA

Sponsors

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

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
5 Years to 12 Years
Healthy volunteers
No

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 \-

Design outcomes

Primary

MeasureTime frameDescription
CD4 count6 monthsA measure of immune competence. CD4 count could range from 500-1500 cells/mm3. Lower values can be seen with advancing HIV disease

Secondary

MeasureTime frameDescription
Serum vitamin A levels6 monthsTo 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
Red cell vitamin B6 levels6 monthsTo identify B6 deficiency. 250-680 pmol/g haemoglobin will be the reference range used
Serum Copper levels6 monthsTo evaluate copper deficiency. 12.5 to 22μmol/L will be the reference range used
Red cell manganese levels6 monthsTo determine deficiency. Reference range not yet established
Red cell Magnesium6 monthsTo determine deficiency levels. Reference range of 5.80-8.55 μmol/g haemoglobin will be used
Serum vitamin E levels6 monthsTo determine deficiency. Reference range of 3.5 - 9.5 μmol/mmol cholesterol will be used
Red cell selenium levels6 monthsTo measure selenium deficiency.3.6 - 10.6 nmol/g haemoglobin will be the reference range used
Red cell zinc levels6 monthsTo determine zinc deficiency. 423-781 nmol/g haemoglobin will be the reference range used
Red cell Copper levels6 monthsTo evaluate copper deficiency. 27.9-53.4 nmol/g haemoglobin will be the reference range used
Serum selenium levels6 monthsTo measure selenium deficiency. Range of 70µg/L -100µg/L have been proposed to describe adequacy of selenium levels in serum.
Serum zinc levels6 monthsTo determine levels of zinc deficiency. 80µg/dL is often used as a cutoff point to signify deficiency in serum

Other

MeasureTime frameDescription
Serum Aspartate aminotransferase (AST) levels (IU/L)6 monthsAs part of routine tests
Serum Bilirubin levels (mg/dl)6 monthsAs part of routine tests
Serum Albumin levels (g/dl)6 monthsAs part of routine tests
Serum Creatinine levels (mg/dl)6 monthsAs part of routine tests
Serum Urea levels (mg/dl)6 monthsAs part of routine tests
Serum C- Reactive Protein levels (mg/L)6 monthsAs part of routine tests
Hemoglobin (g/dl)6 monthsAs part of routine tests
Serum Alanine aminotransferase (ALT) levels (U/L)6 monthsAs part of routine tests

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 18, 2026