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Clinical Trials

MainTitle

The Role of Multivitamins in Pediatric HIV Management in Nigeria

The recruitment status of this study is unknown.

Verified September 2015 by Regina Esiovwa, University of the West of Scotland

Sponsor
Regina Esiovwa

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

Information provided by (Responsible Party)
Regina Esiovwa, University of the West of Scotland

ClinicalTrials.gov Identifier
NCT02552602

First received: September 9, 2015
Last updated: September 16, 2015
Last Verified: September 2015
History of Changes
Purpose

Purpose

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.

Condition Intervention
HIV

Dietary Supplement : Multivitamin A
Dietary Supplement : Multivitamin B
Dietary Supplement : Multivitamin C

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Supportive Care
Official Title: The Role of Multivitamins in Pediatric HIV Management in Nigeria: A Randomized Controlled Study

Further study details as provided by Regina Esiovwa, University of the West of Scotland:

Primary Outcome Measures

  • 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
Secondary Outcome Measures:
  • 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.
  • 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
  • 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
  • Red cell vitamin B6 levels [ Time Frame: 6 months ]
    To identify B6 deficiency. 250-680 pmol/g haemoglobin will be the reference range used
  • Serum Copper levels [ Time Frame: 6 months ]
    To evaluate copper deficiency. 12.5 to 22μmol/L will be the reference range used
  • Red cell manganese levels [ Time Frame: 6 months ]
    To determine deficiency. Reference range not yet established
  • Red cell Magnesium [ Time Frame: 6 months ]
    To determine deficiency levels. Reference range of 5.80-8.55 μmol/g haemoglobin will be used
  • Serum vitamin E levels [ Time Frame: 6 months ]
    To determine deficiency. Reference range of 3.5 - 9.5 μmol/mmol cholesterol will be used
  • 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
  • Red cell zinc levels [ Time Frame: 6 months ]
    To determine zinc deficiency. 423-781 nmol/g haemoglobin will be the reference range used
  • 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
Other Outcome Measures:
  • Hemoglobin (g/dl) [ Time Frame: 6 months ]
    As part of routine tests
  • Serum Alanine aminotransferase (ALT) levels (U/L) [ Time Frame: 6 months ]
    As part of routine tests
  • Serum Aspartate aminotransferase (AST) levels (IU/L) [ Time Frame: 6 months ]
    As part of routine tests
  • Serum Bilirubin levels (mg/dl) [ Time Frame: 6 months ]
    As part of routine tests
  • Serum Albumin levels (g/dl) [ Time Frame: 6 months ]
    As part of routine tests
  • Serum Creatinine levels (mg/dl) [ Time Frame: 6 months ]
    As part of routine tests
  • Serum Urea levels (mg/dl) [ Time Frame: 6 months ]
    As part of routine tests
  • Serum C- Reactive Protein levels (mg/L) [ Time Frame: 6 months ]
    As part of routine tests

Enrollment: 190
Study Start Date: May 2015
Estimated Study Completion Date: February 2016
Estimated Primary Completion Date: February 2016 (Final data collection date for primary outcome measure)

Arms Assigned Interventions
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

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.

Eligibility

Eligibility

Ages Eligible for Study: 5 Years to 12 Years  
Sexes Eligible for Study: All  
Accepts Healthy Volunteers: No  

Criteria

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

contacts and locations

Contacts and Locations

Choosing to participate in a study is an important personal decision.Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02552602

Sponsors and Collaborators

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

Investigators

Principal Investigator: Regina Esiovwa University of the West of Scotland
More Information

More Information


Responsible Party: Regina Esiovwa, PhD Student, University of the West of Scotland  
ClinicalTrials.gov Identifier: NCT02552602   History of Changes  
Other Study ID Numbers: REGPHD2015  
Study First Received: September 9, 2015  
Last Updated: September 16, 2015  

Keywords provided by Regina Esiovwa, University of the West of Scotland:

HIV
Multivitamins

ClinicalTrials.gov processed this data on October 20, 2017
This information is provided by ClinicalTrials.gov.