MalariaPhase 3NCT02878265
The Effect of Vitamin A With and Without Zinc and Multivitamin Supplementation on Malaria Morbidity in Ghanaian Children
A Phase 3 study testing Vitamin A, Vitamin A and ZInc and Vitamin A , Zinc and Multivitamin in people with Malaria, run by University of Ghana at 1 site in Ghana.
Trial summary
The aim of this study was to determine the effect of combining vitamin A (VA), zinc (Z) and multivitamins (MV- A, B1, B2, B6, B12, C, D and E) on malaria morbidity Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Malaria
- What is being tested?
- Vitamin A, Vitamin A and ZInc and Vitamin A , Zinc and Multivitamin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 547 participants
- Where
- 1 siteGhana
- Study dates
- Nov 2011to Dec 2012
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- under 5years
- will stay in the community for 10years
Who cannot join
- chronic diseases
Trial locations and contacts
1 site in 1 country.
About this study
The aim of this study was to determine the effect of combining vitamin A (VA), zinc (Z) and multivitamins (MV- A, B1, B2, B6, B12, C, D and E) on malaria morbidity
Read the detailed description
A total of 542 children aged between 6-59 months received either: (i) VA (control) or (ii) VA \& Z (VAZ) or (iii) VA, Z \& MV (VAZM). VA was delivered as a single dose while MV and Z were delivered daily. Malaria cases were managed by community health workers, who used rapid diagnostic test to confirm infection prior to treatment.
- Conditions
- Malaria
- Being tested
- Vitamin A, Vitamin A and ZInc, Vitamin A , Zinc and Multivitamin
- Keywords
- malaria, vitamin A, Zinc, Multivitamin
- Medical subject headings
- Malaria
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vitamin ADietary supplement
Also called VA
Vitamin A supplements
Vitamin A and ZIncDietary supplement
Also called VAZ
Combination of vitamin A and zinc supplements
Vitamin A , Zinc and MultivitaminDietary supplement
Also called VAZM
Combination of vitamin A, zinc and multivitamins
| Study group | Role | What they receive |
|---|---|---|
| Vitamin A | Placebo comparator | A single dose of 20,000IU Vitamin A for the whole study period Receives: Dietary Supplement: Vitamin A |
| Vitamin A and zinc | Active comparator | A single dose of 20,000IU Vitamin A and 10mg of elemental zinc each day for 5 months Receives: Dietary Supplement: Vitamin A and ZInc |
| Vitamin A , Zinc and Multivitamin | Active comparator | A single dose of 20,000IU Vitamin A , 10mg of elemental zinc each day and 0.5ml/kg multivitamin syrup for 5 months Receives: Dietary Supplement: Vitamin A , Zinc and Multivitamin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of clinical malaria attacks
While taking the supplement, malaria incidence will be measured
Measured: Baseline and every month up to six months
Secondary outcomes (1)
Incidence of diarrhea attacks
While taking the supplement, diarrhea incidence will be measured
Measured: Every month up to six months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Aug 2016 (estimated)
- Study startNov 2011
- Primary completionMay 2012
- Study completionDec 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for MalariaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 547 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Ghana
- Sponsor type
- University, hospital or other
- Collaborators
- Kwame Nkrumah University of Science and Technology
- Responsible party
- Principal investigator, Wilhelmina Annie Mensah, University of Ghana
- Investigators
- Patricia k Brown, PhD, Study chair, Kwame Nkrumah Univeristy of Science and TechnolgyWilhelmina A Mensah, Mphil, Principal investigator, University of Ghana
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02878265
- Sponsor's protocol ID
- VAZ20016
- Status last verified
- Aug 2016
- First submitted
- 16 Aug 2016
- Last updated
- 25 Aug 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Yes: To meet the participants and explain the results of their data to them
Publications
Veenemans J, Milligan P, Prentice AM, Schouten LR, Inja N, van der Heijden AC, de Boer LC, Jansen EJ, Koopmans AE, Enthoven WT, Kraaijenhagen RJ, Demir AY, Uges DR, Mbugi EV, Savelkoul HF, Verhoef H. Effect of supplementation with zinc and other micronutrients on malaria in Tanzanian children: a randomised trial. PLoS Med. 2011 Nov;8(11):e1001125. doi: 10.1371/journal.pmed.1001125. Epub 2011 Nov 22.
PubMed 22131908Zeba AN, Sorgho H, Rouamba N, Zongo I, Rouamba J, Guiguemde RT, Hamer DH, Mokhtar N, Ouedraogo JB. Major reduction of malaria morbidity with combined vitamin A and zinc supplementation in young children in Burkina Faso: a randomized double blind trial. Nutr J. 2008 Jan 31;7:7. doi: 10.1186/1475-2891-7-7.
PubMed 18237394Owusu-Agyei S, Newton S, Mahama E, Febir LG, Ali M, Adjei K, Tchum K, Alhassan L, Moleah T, Tanumihardjo SA. Impact of vitamin A with zinc supplementation on malaria morbidity in Ghana. Nutr J. 2013 Sep 23;12:131. doi: 10.1186/1475-2891-12-131.
PubMed 24330422Imdad A, Herzer K, Mayo-Wilson E, Yakoob MY, Bhutta ZA. Vitamin A supplementation for preventing morbidity and mortality in children from 6 months to 5 years of age. Cochrane Database Syst Rev. 2010 Dec 8;(12):CD008524. doi: 10.1002/14651858.CD008524.pub2.
PubMed 21154399
Study at a glance
From the registry record, last updated by the sponsor on 25 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Vitamin A With and Without Zinc and Multivitamin Supplementation on Malaria Morbidity in Ghanaian Children
- ClinicalTrials.gov ID
- NCT02878265
- Acronym / sponsor ID
- VAZ20016
- Conditions
- Malaria
- Keywords
- malaria, vitamin A, Zinc, Multivitamin
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 547 participants (actual)
- Lead sponsor
- University of GhanaUniversity, hospital or other
- Collaborators
- Kwame Nkrumah University of Science and Technology
- Study start
- Nov 2011
- Primary completion
- May 2012 (actual)
- Study completion
- Dec 2012 (actual)
- First posted
- 25 Aug 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The aim of this study was to determine the effect of combining vitamin A (VA), zinc (Z) and multivitamins (MV- A, B1, B2, B6, B12, C, D and E) on malaria morbidity
Detailed description
A total of 542 children aged between 6-59 months received either: (i) VA (control) or (ii) VA \& Z (VAZ) or (iii) VA, Z \& MV (VAZM). VA was delivered as a single dose while MV and Z were delivered daily. Malaria cases were managed by community health workers, who used rapid diagnostic test to confirm infection prior to treatment.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Vitamin A | Placebo comparator | Dietary Supplement: Vitamin AA single dose of 20,000IU Vitamin A for the whole study period |
| Vitamin A and zinc | Active comparator | Dietary Supplement: Vitamin A and ZIncA single dose of 20,000IU Vitamin A and 10mg of elemental zinc each day for 5 months |
| Vitamin A , Zinc and Multivitamin | Active comparator | Dietary Supplement: Vitamin A , Zinc and MultivitaminA single dose of 20,000IU Vitamin A , 10mg of elemental zinc each day and 0.5ml/kg multivitamin syrup for 5 months |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- under 5years
- will stay in the community for 10years
Key exclusion criteria (1 listed)
- chronic diseases
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Vitamin AAlso: VAVitamin A supplements | Dietary supplement | Vitamin A |
| Vitamin A and ZIncAlso: VAZCombination of vitamin A and zinc supplements | Dietary supplement | Vitamin A and zinc |
| Vitamin A , Zinc and MultivitaminAlso: VAZMCombination of vitamin A, zinc and multivitamins | Dietary supplement | Vitamin A , Zinc and Multivitamin |
Primary outcome
Incidence of clinical malaria attacks
Time frame: Baseline and every month up to six months
While taking the supplement, malaria incidence will be measured
1 secondary outcome
Incidence of diarrhea attacks
Time frame: Every month up to six months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Aug 2016.
- Background: PubMed 22131908Veenemans J, Milligan P, Prentice AM, Schouten LR, Inja N, van der Heijden AC, de Boer LC, Jansen EJ, Koopmans AE, Enthoven WT, Kraaijenhagen RJ, Demir AY, Uges DR, Mbugi EV, Savelkoul HF, Verhoef H. Effect of supplementation with zinc and other micronutrients on malaria in Tanzanian children: a randomised trial. PLoS Med. 2011 Nov;8(11):e1001125. doi: 10.1371/journal.pmed.1001125. Epub 2011 Nov 22.
- Results publication: PubMed 18237394Zeba AN, Sorgho H, Rouamba N, Zongo I, Rouamba J, Guiguemde RT, Hamer DH, Mokhtar N, Ouedraogo JB. Major reduction of malaria morbidity with combined vitamin A and zinc supplementation in young children in Burkina Faso: a randomized double blind trial. Nutr J. 2008 Jan 31;7:7. doi: 10.1186/1475-2891-7-7.
- Results publication: PubMed 24330422Owusu-Agyei S, Newton S, Mahama E, Febir LG, Ali M, Adjei K, Tchum K, Alhassan L, Moleah T, Tanumihardjo SA. Impact of vitamin A with zinc supplementation on malaria morbidity in Ghana. Nutr J. 2013 Sep 23;12:131. doi: 10.1186/1475-2891-12-131.
- Results publication: PubMed 21154399Imdad A, Herzer K, Mayo-Wilson E, Yakoob MY, Bhutta ZA. Vitamin A supplementation for preventing morbidity and mortality in children from 6 months to 5 years of age. Cochrane Database Syst Rev. 2010 Dec 8;(12):CD008524. doi: 10.1002/14651858.CD008524.pub2.
- Individual participant dataSharing planned: Yes. To meet the participants and explain the results of their data to them
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Patricia k Brown, PhD study chair
Kwame Nkrumah Univeristy of Science and Technolgy
Wilhelmina A Mensah, Mphil principal investigator
University of Ghana
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Vitamin A, Vitamin A and ZInc and Vitamin A , Zinc and Multivitamin in people with Malaria, run by University of Ghana at 1 site in Ghana.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Aug 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Ghana. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of clinical malaria attacks (time frame: Baseline and every month up to six months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02878265, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Aug 2016.