MalariaMAL2NCT01115478
Malaria in Pregnancy: Nutrition and Immunologic Effects
A study testing Vitamin A and Zinc in people with Malaria and Low Birth Weight, run by Harvard School of Public Health (HSPH) at 1 site in Tanzania.
Trial summary
The purpose of this study is to determine the efficacy of zinc and/or vitamin A supplementation in reducing the risk of placental malaria and its associated adverse pregnancy outcomes. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Malaria, Low Birth Weight, Anemia
- What is being tested?
- Vitamin A and Zinc
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 2,500 participants
- Where
- 1 siteTanzania
- Study dates
- Jul 2010to Jun 2014
- Phase
- Interventional
- 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 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Primigravida or secundigravidae
- At or before 13 weeks of gestation
- HIV-negative
- Intend to stay in Dar es Salaam until delivery and for at least 6 weeks thereafter
Who cannot join
- Not primigravida or secundigravidae
- After 13 weeks of gestation
- HIV-positive
- Do not intend to stay in Dar es Salaam until delivery and for at least 6 weeks thereafter
Trial locations and contacts
1 site in 1 country.
Tanzania1 site
Muhimbili University of Health And Allied Sciences
Dar es Salaam, PO BOX 65001
About this study
The purpose of this study is to determine the efficacy of zinc and/or vitamin A supplementation in reducing the risk of placental malaria and its associated adverse pregnancy outcomes.
Read the detailed description
Malaria accounts for a major proportion of the disease burden in Tanzania with 14 to 18 million new malaria cases being reported each year resulting in 100,000-125,000 deaths. Malaria results in impaired productivity for those between 15-55 years and lost learning opportunities in the 5-25 year age group. Dar es Salaam is characterized as an area with endemic and perennial malaria, with transmission occurring during the entire year. P. falciparum accounts for more than 95% of malaria infections. A number of interventions have contributed to reducing the burden of the disease in some settings in Tanzania and beyond, including vector control measures, bed nets, and prophylaxis and treatment of malaria. However, malaria remains a serious problem among pregnant women and children. We will examine the efficacy of micronutrient supplements as a means of enhancing immune response to malaria in pregnancy and reducing the risks of associated adverse clinical outcomes. If successful, such a low-cost intervention would be added to the armamentarium against this disease.
NOTE: The time frames listed for the maternal malaria and hemoglobin outcomes were updated on 4/22/15. This record initially indicated that maternal malaria anemia and hemoglobin would be measured at several specific time points throughout the study. Instead, maternal malaria was measured throughout pregnancy and hemoglobin was measured only at delivery. Due to an oversight, we did not update this record when this protocol change took effect at the start of the study.
- Conditions
- Malaria, Low Birth Weight, Anemia, Perinatal Mortality
- Being tested
- Vitamin A, Zinc, Placebo
- Keywords
- Malaria, Low birth weight, Anemia, Perinatal mortality, Vitamin A, Zinc
- Medical subject headings
- Malaria, Anemia, Perinatal Death
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vitamin ADietary supplement
Daily oral dose of 2500 IU from enrollment until delivery
ZincDietary supplement
Daily oral dose of 25 mg from enrollment until delivery
PlaceboOther
Daily oral dose from enrollment until delivery
| Study group | Role | What they receive |
|---|---|---|
| Vitamin A | Active comparator | Not described Receives: Dietary Supplement: Vitamin A |
| Zinc | Active comparator | Not described Receives: Dietary Supplement: Zinc |
| Vitamin A + Zinc | Active comparator | Not described Receives: Dietary Supplement: Vitamin A; Dietary Supplement: Zinc |
| Placebo | Placebo comparator | Not described Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of placental malaria
Placental infection status will be categorized as infected if there are asexual parasites in the placenta blood; not infected if the placental blood smear is negative; or status unknown if no placental smear is available.
Measured: Delivery
Low birth weight
Low birth weight will be defined as birth weight less than 2500 grams.
Measured: Delivery
Secondary outcomes (3)
Maternal anemia
Anemia is defined as hemoglobin less than 11 g/dl. Severe anemia is less than 8.5 g/dl.
Measured: Delivery
Perinatal death
Measured: at or after 28 weeks of gestation and in the first 7 days of life
Maternal malaria
Maternal malaria will be defined as fever within the last 72 hours with any parasitemia on a peripheral blood smear.
Measured: During pregnancy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 May 2010 (estimated)
- Study startJul 2010
- Primary completionJun 2014
- Study completionJun 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)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 N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 2,500 participants (actual)
Sponsor and investigators
- Lead sponsor
- Harvard School of Public Health (HSPH)
- Sponsor type
- University, hospital or other
- Collaborators
- Muhimbili University of Health and Allied Sciences
- Responsible party
- Principal investigator, Wafaie Fawzi, Harvard School of Public Health (HSPH)
- Investigators
- Wafaie W Fawzi, MD, DrPH, Principal investigator, Harvard School of Public Health (HSPH)Ferdinand Mugusi, MD, MMed, Principal investigator, Muhimbili University of Health and Allied Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01115478
- Sponsor's protocol ID
- HD57941-01A2
- Acronym
- MAL2
- Status last verified
- Apr 2015
- First submitted
- 30 Apr 2010
- Last updated
- 24 Apr 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Yang J, Wang D, Darling AM, Liu E, Perumal N, Fawzi WW, Wang M. Methodological approaches to imputing early-pregnancy weight based on weight measures collected during pregnancy. BMC Med Res Methodol. 2021 Feb 5;21(1):24. doi: 10.1186/s12874-021-01210-3.
PubMed 33546607
Study at a glance
From the registry record, last updated by the sponsor on 24 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Malaria in Pregnancy: Nutrition and Immunologic Effects
- ClinicalTrials.gov ID
- NCT01115478
- Acronym / sponsor ID
- MAL2 / HD57941-01A2
- Conditions
- Malaria, Low Birth Weight, Anemia, Perinatal Mortality
- Keywords
- Malaria, Low birth weight, Anemia, Perinatal mortality, Vitamin A, Zinc
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 2,500 participants (actual)
- Lead sponsor
- Harvard School of Public Health (HSPH)University, hospital or other
- Collaborators
- Muhimbili University of Health and Allied Sciences
- Study start
- Jul 2010
- Primary completion
- Jun 2014 (actual)
- Study completion
- Jun 2014 (actual)
- First posted
- 4 May 2010 (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 is to determine the efficacy of zinc and/or vitamin A supplementation in reducing the risk of placental malaria and its associated adverse pregnancy outcomes.
Detailed description
Malaria accounts for a major proportion of the disease burden in Tanzania with 14 to 18 million new malaria cases being reported each year resulting in 100,000-125,000 deaths. Malaria results in impaired productivity for those between 15-55 years and lost learning opportunities in the 5-25 year age group. Dar es Salaam is characterized as an area with endemic and perennial malaria, with transmission occurring during the entire year. P. falciparum accounts for more than 95% of malaria infections. A number of interventions have contributed to reducing the burden of the disease in some settings in Tanzania and beyond, including vector control measures, bed nets, and prophylaxis and treatment of malaria. However, malaria remains a serious problem among pregnant women and children. We will examine the efficacy of micronutrient supplements as a means of enhancing immune response to malaria in pregnancy and reducing the risks of associated adverse clinical outcomes. If successful, such a low-cost intervention would be added to the armamentarium against this disease.
NOTE: The time frames listed for the maternal malaria and hemoglobin outcomes were updated on 4/22/15. This record initially indicated that maternal malaria anemia and hemoglobin would be measured at several specific time points throughout the study. Instead, maternal malaria was measured throughout pregnancy and hemoglobin was measured only at delivery. Due to an oversight, we did not update this record when this protocol change took effect at the start of the study.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Vitamin A | Active comparator | Dietary Supplement: Vitamin A |
| Zinc | Active comparator | Dietary Supplement: Zinc |
| Vitamin A + Zinc | Active comparator | Dietary Supplement: Vitamin A, Dietary Supplement: Zinc |
| Placebo | Placebo comparator | Other: Placebo |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Primigravida or secundigravidae
- At or before 13 weeks of gestation
- HIV-negative
- Intend to stay in Dar es Salaam until delivery and for at least 6 weeks thereafter
Key exclusion criteria (4 listed)
- Not primigravida or secundigravidae
- After 13 weeks of gestation
- HIV-positive
- Do not intend to stay in Dar es Salaam until delivery and for at least 6 weeks thereafter
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 ADaily oral dose of 2500 IU from enrollment until delivery | Dietary supplement | Vitamin A, Vitamin A + Zinc |
| ZincDaily oral dose of 25 mg from enrollment until delivery | Dietary supplement | Vitamin A + Zinc, Zinc |
| PlaceboDaily oral dose from enrollment until delivery | Other | Placebo |
Primary outcome
Incidence of placental malaria
Time frame: Delivery
Placental infection status will be categorized as infected if there are asexual parasites in the placenta blood; not infected if the placental blood smear is negative; or status unknown if no placental smear is available.
Low birth weight
Time frame: Delivery
Low birth weight will be defined as birth weight less than 2500 grams.
3 secondary outcomes
Maternal anemia
Time frame: Delivery
Perinatal death
Time frame: at or after 28 weeks of gestation and in the first 7 days of life
Maternal malaria
Time frame: During pregnancy
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 24 Apr 2015.
- Derived from this study: PubMed 33546607Yang J, Wang D, Darling AM, Liu E, Perumal N, Fawzi WW, Wang M. Methodological approaches to imputing early-pregnancy weight based on weight measures collected during pregnancy. BMC Med Res Methodol. 2021 Feb 5;21(1):24. doi: 10.1186/s12874-021-01210-3.
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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.
Wafaie W Fawzi, MD, DrPH principal investigator
Harvard School of Public Health (HSPH)
Ferdinand Mugusi, MD, MMed principal investigator
Muhimbili University of Health and Allied Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Vitamin A and Zinc in people with Malaria and Low Birth Weight, run by Harvard School of Public Health (HSPH) at 1 site in Tanzania.
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 4 inclusion and 4 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 24 Apr 2015. 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 Tanzania. 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.
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 placental malaria (time frame: Delivery). The study lists 2 primary outcomes in all. 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 NCT01115478, which also lists 1 linked publication.
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 24 Apr 2015.