The Role of Multivitamins in Pediatric HIV Management in Nigeria

NCT02552602 | Unknown DMC

• 1 other identifier: REGPHD2015
• Study Type: interventional
• Target: 190
• Locations: 0 countries
• Sites: N/A

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.

Conditions

HIV

Keywords

HIV; Multivitamins

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (11)

• Serum selenium levels

  6 months

• Serum zinc levels

  6 months

• Serum vitamin A levels

  6 months

• Red cell vitamin B6 levels

  6 months

• Serum Copper levels

  6 months

Other Outcomes (8)

• Hemoglobin (g/dl)

  6 months

• Serum Alanine aminotransferase (ALT) levels (U/L)

  6 months

• Serum Aspartate aminotransferase (AST) levels (IU/L)

  6 months

Study Arms (3)

Group A

ACTIVE COMPARATOR

Study participants in this arm will be given Multivitamin A

Dietary Supplement: Multivitamin A

Group B

ACTIVE COMPARATOR

Study participants in this arm will be given Multivitamin B

Dietary Supplement: Multivitamin B

Group C

ACTIVE COMPARATOR

Study participants in this arm will be given Multivitamin C

Dietary Supplement: Multivitamin C

Interventions

Multivitamin A DIETARY_SUPPLEMENT

Multivitamin containing 7 micronutrients at recommended daily allowance (RDA)

Group A

Multivitamin B DIETARY_SUPPLEMENT

Multivitamin containing 22 micronutrients at RDA

Group B

Multivitamin C DIETARY_SUPPLEMENT

Multivitamin containing 22 micronutrients at three times the RDA

Group C

Eligibility Criteria

• Age: 5 Years - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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 -

You may not qualify if:

• Children enrolled in other studies
• Guardians and children anticipating moving away from the study state
• Children receiving immunosuppressive therapy

Sponsors & Collaborators

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

Related Publications (22)

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• Esiovwa R, Rankin J, David A, Disu E, Wapmuk A, Amoo O. The Role of Multimicronutrient Supplementation in Pediatric HIV Management in Nigeria: A Randomized Controlled Study. J Pediatric Infect Dis Soc. 2021 Mar 26;10(2):112-117. doi: 10.1093/jpids/piaa025.

  PMID: 32202619 DERIVED

Study Officials

• Regina Esiovwa

  University of the West of Scotland

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: PhD Student

Study Record Dates

• First Submitted: September 9, 2015
• First Posted: September 17, 2015
• Study Start: May 1, 2015
• Primary Completion: February 1, 2016
• Study Completion: February 1, 2016
• Last Updated: September 17, 2015

Record last verified: 2015-09