MalariaPhase 3NCT01782001
Evaluation of Vitamin A and Zinc Supplementation on Malarial Morbidity
A Phase 3 study testing vitamin A and vitamin A and zinc in people with Malaria and Malnutrition, run by Kintampo Health Research Centre, Ghana at 1 site in Ghana.
Trial summary
The purpose of this study was to determine whether young children receiving Vitamin A and Zinc supplements will have a lower incidence of symptomatic malaria than similar children receiving vitamin A supplements alone. Read more about this study
- Who is it for?
- Ages 6 to 24 months
- Conditions the study is for
- Malaria, Malnutrition
- What is being tested?
- vitamin A and vitamin A and zinc
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteGhana
- Study dates
- Mar 2009to Nov 2009
- 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 6 to 24 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Children aged 6 - 24 months
- Child's guardian is willing to provide informed consent
- Child's family plans to remain resident in the study areas during the study period
Who cannot join
- Clinical evidence of vitamin A deficiency
- Severe acute malnutrition
- Severe illness
- Child aged <6 months or >24 months
- Receipt of vitamin A supplement within the last three months
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of the Impact of Vitamin A and Zinc Supplementation on Malarial Morbidity in Ghana
The purpose of this study was to determine whether young children receiving Vitamin A and Zinc supplements will have a lower incidence of symptomatic malaria than similar children receiving vitamin A supplements alone.
Read the detailed description
The aim of our study was to determine the impact of the combination of vitamin A and zinc supplements on malaria morbidity in young children. The primary objective was to determine the effect of vitamin A alone vs. vitamin A and zinc supplements on the incidence of clinical malaria. The specific objectives were to determine the effect of vitamin A alone vs. vitamin A and zinc supplements on changes in anthropometric measurements specifically weight and length/height and to assess the effect of the study interventions on the incidence of anemia, diarrhea and pneumonia. It also assessed the tolerability of the supplements and determined the change in zinc status by measuring plasma zinc concentration using atomic absorption spectrometry before and at the end of the intervention. The study also determined the change in vitamin A status as assessed by the modified relative dose response (MRDR) test during and at the end of the intervention.
- Conditions
- Malaria, Malnutrition
- Being tested
- vitamin A, vitamin A and zinc
- Keywords
- Vitamin A, Zinc, Malaria, Morbidity, MRDR
- Medical subject headings
- Malaria, Malnutrition
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
vitamin ADietary supplement
vitamin A with placebo
vitamin A and zincDietary supplement
combination of vitamin A and zinc supplements
| Study group | Role | What they receive |
|---|---|---|
| Vitamin A and zinc | Experimental | combination of vitamin A and zinc supplements Receives: Dietary Supplement: vitamin A and zinc |
| Vitamin A and placebo | Active comparator | vitamin A with placebo Receives: Dietary Supplement: vitamin A |
What is being measured
The primary outcome is the main question the study is designed to answer.
incidence of clinical malaria attacks
Measured: 6 months
Secondary outcomes (4)
changes in weight and height/length
Enrollment and end of supplementation
Measured: baseline and 6 months
changes in vitamin A and zinc nutritional status within and between the groups
enrollment and end of supplementation
Measured: baseline and 6 months
change in prevalence of anemia
enrollment and end of supplementation
Measured: baseline and 6 months
the incidence of diarrhea and pneumonia
1 time/week, enrollment to end, total:24
Measured: 1 time per week up to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Feb 2013 (estimated)
- Study startMar 2009
- Primary completionNov 2009
- Study completionNov 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kintampo Health Research Centre, Ghana
- Sponsor type
- University, hospital or other
- Collaborators
- International Atomic Energy Agency, University of Wisconsin, Madison
- Responsible party
- Sponsor
- Investigators
- Seth Owusu-Agyei, PhD, Principal investigator, Kintampo Health Research Centre, Ghana
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01782001
- Sponsor's protocol ID
- AMANI
- Status last verified
- Jan 2013
- First submitted
- 27 Jan 2013
- Last updated
- 1 Feb 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 1 Feb 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Impact of Vitamin A and Zinc Supplementation on Malarial Morbidity in Ghana
- ClinicalTrials.gov ID
- NCT01782001
- Acronym / sponsor ID
- AMANI
- Conditions
- Malaria, Malnutrition
- Keywords
- Vitamin A, Zinc, Malaria, Morbidity, MRDR
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Kintampo Health Research Centre, GhanaUniversity, hospital or other
- Collaborators
- International Atomic Energy Agency, University of Wisconsin, Madison
- Study start
- Mar 2009
- Primary completion
- Nov 2009 (actual)
- Study completion
- Nov 2009 (actual)
- First posted
- 1 Feb 2013 (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 purpose of this study was to determine whether young children receiving Vitamin A and Zinc supplements will have a lower incidence of symptomatic malaria than similar children receiving vitamin A supplements alone.
Detailed description
The aim of our study was to determine the impact of the combination of vitamin A and zinc supplements on malaria morbidity in young children. The primary objective was to determine the effect of vitamin A alone vs. vitamin A and zinc supplements on the incidence of clinical malaria. The specific objectives were to determine the effect of vitamin A alone vs. vitamin A and zinc supplements on changes in anthropometric measurements specifically weight and length/height and to assess the effect of the study interventions on the incidence of anemia, diarrhea and pneumonia. It also assessed the tolerability of the supplements and determined the change in zinc status by measuring plasma zinc concentration using atomic absorption spectrometry before and at the end of the intervention. The study also determined the change in vitamin A status as assessed by the modified relative dose response (MRDR) test during and at the end of the intervention.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Vitamin A and zinc | Experimental | Dietary Supplement: vitamin A and zinccombination of vitamin A and zinc supplements |
| Vitamin A and placebo | Active comparator | Dietary Supplement: vitamin Avitamin A with placebo |
Who may qualify
- Ages
- 6 to 24 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Children aged 6 - 24 months
- Child's guardian is willing to provide informed consent
- Child's family plans to remain resident in the study areas during the study period
Key exclusion criteria (5 listed)
- Clinical evidence of vitamin A deficiency
- Severe acute malnutrition
- Severe illness
- Child aged <6 months or >24 months
- Receipt of vitamin A supplement within the last three months
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 Avitamin A with placebo | Dietary supplement | Vitamin A and placebo |
| vitamin A and zinccombination of vitamin A and zinc supplements | Dietary supplement | Vitamin A and zinc |
Primary outcome
incidence of clinical malaria attacks
Time frame: 6 months
4 secondary outcomes
changes in weight and height/length
Time frame: baseline and 6 months
changes in vitamin A and zinc nutritional status within and between the groups
Time frame: baseline and 6 months
change in prevalence of anemia
Time frame: baseline and 6 months
the incidence of diarrhea and pneumonia
Time frame: 1 time per week up to 6 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 1 Feb 2013.
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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.
Seth Owusu-Agyei, PhD principal investigator
Kintampo Health Research Centre, 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 and vitamin A and zinc in people with Malaria and Malnutrition, run by Kintampo Health Research Centre, 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 3 inclusion and 5 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 1 Feb 2013. 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. 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: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 1 Feb 2013.