The Role of Multivitamins in Pediatric HIV Management in Nigeria

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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HIV

Intervention / Treatment
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* Dietary Supplement: Multivitamin A
* Dietary Supplement: Multivitamin B
* Dietary Supplement: Multivitamin C


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Children aged 5 - 12 years attending the outpatient clinic of the two HIV treatment centers who have tested positive to HIV Children who can return for follow up during the 6 months of the study Children with guardians who can give informed consent - Exclusion Criteria: Children enrolled in other studies Guardians and children anticipating moving away from the study state Children receiving immunosuppressive therapy -

Ages Eligible for Study
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Minimum Age: 5 Years
Maximum Age: 12 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Group A<br>Study participants in this arm will be given Multivitamin A | Dietary Supplement: Multivitamin A<br>* Multivitamin containing 7 micronutrients at recommended daily allowance (RDA)<br>|
| Active Comparator: Group B<br>Study participants in this arm will be given Multivitamin B | Dietary Supplement: Multivitamin B<br>* Multivitamin containing 22 micronutrients at RDA<br>|
| Active Comparator: Group C<br>Study participants in this arm will be given Multivitamin C | Dietary Supplement: Multivitamin C<br>* Multivitamin containing 22 micronutrients at three times the RDA<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| CD4 count | 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 | 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 | 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 | 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 | To identify B6 deficiency. 250-680 pmol/g haemoglobin will be the reference range used | 6 months | 
| Serum Copper levels | To evaluate copper deficiency. 12.5 to 22μmol/L will be the reference range used | 6 months | 
| Red cell manganese levels | To determine deficiency. Reference range not yet established | 6 months | 
| Red cell Magnesium | To determine deficiency levels. Reference range of 5.80-8.55 μmol/g haemoglobin will be used | 6 months | 
| Serum vitamin E levels | To determine deficiency. Reference range of 3.5 - 9.5 μmol/mmol cholesterol will be used | 6 months | 
| Red cell selenium levels | To measure selenium deficiency.3.6 - 10.6 nmol/g haemoglobin will be the reference range used | 6 months | 
| Red cell zinc levels | To determine zinc deficiency. 423-781 nmol/g haemoglobin will be the reference range used | 6 months | 
| Red cell Copper levels | To evaluate copper deficiency. 27.9-53.4 nmol/g haemoglobin will be the reference range used | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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HIV, Multivitamins