MalariaPhase 4PIMALNCT01308112
Prenatal Iron and Malaria Study
A Phase 4 study testing iron in people with Malaria, run by London School of Hygiene and Tropical Medicine at 1 site in Kenya.
Trial summary
The purpose of this study is to compare the presence of Plasmodium infection in parturient women who antenatally received a combination of iron-fortified foods with iron supplements versus iron-fortified foods only. Read more about this study
- Who is it for?
- Ages 15 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Malaria
- What is being tested?
- iron
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 470 participants
- Where
- 1 siteKenya
- Study dates
- Oct 2011to May 2013
- Phase
- Phase 4
- 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 15 to 45 years
- Women only
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Women aged 15-45 years resident in the predefined study area
- Pregnant, with gestational age <23 weeks
Who cannot join
- Failure to provide a blood sample
- Initial haemoglobin concentration <90 g/L
- Reported medical history suggestive of sickle cell anaemia, epilepsy, diabetes
- Obstetric history suggestive of eclampsia or pre-eclampsia
- Obvious mental retardation or metabolic disorder;
- No written consent
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- Carrying multiples
- Woman planning to leave the homestead or to be absent for prolonged periods in the course of the pregnancy or within a 1-month period thereafter
- Woman planning to deliver outside the research clinic.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomised Trial to Assess the Safety and Efficacy or Iron Supplementation in Kenyan Pregnant Women
The purpose of this study is to compare the presence of Plasmodium infection in parturient women who antenatally received a combination of iron-fortified foods with iron supplements versus iron-fortified foods only.
Read the detailed description
As per recommendations by the World Health Organization (WHO), iron supplementation in children should be restricted in malaria-endemic areas because of concerns that it can lead to an increased burden of malaria. Universal iron supplementation continues to be recommended, however, for women during pregnancy and 3 months postpartum. Observational studies have shown that iron deficiency in parturient women is associated with a marked reduction in the prevalence and density of malarial parasites in the placenta. Plasmodium infections in pregnant women have devastating effects on the foetus and neonate, causing low birth weight, intrauterine growth retardation, preterm delivery, spontaneous abortion, stillbirth and neonatal mortality. Based on our previous work, the Kenyan government is currently drafting legislation for mandatory iron fortification of industrially milled flour. Implementation of the new fortification policy means that pregnant women will receive iron through a combination of fortified foods and supplementation. The investigators are concerned about the safety of the high iron intake resulting from such a policy.
- Conditions
- Malaria
- Being tested
- iron
- Keywords
- Iron, Plasmodium, Malaria, Pregnancy, Kenya
- Medical subject headings
- Malaria
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ironDietary supplement
Daily supplementation with iron (60 mg) as ferrous sulphate
| Study group | Role | What they receive |
|---|---|---|
| Supplemental iron | Experimental | Not described Receives: Dietary Supplement: iron |
| Placebo | Placebo comparator | Not described Receives: Dietary Supplement: iron |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maternal Plasmodium infection
Assessed by LDH- and HRP2-based dipstick test and PCR
Measured: Parturition
Secondary outcomes (4)
Serum non-transferrin bound iron concentration
Measured: 3 h after ingestion of first supplement with either iron or placebo
Neonatal iron stores
Assessed by plasma ferritin concentration, restricted to infants without inflammation
Measured: At 1 month of age
Maternal iron status
To be assessed by haemoglobin concentrations, prevalence of iron deficiency anaemia (plasma ferritin concentration <12 µg/L) and iron stores (ratio of ferritin:transferrin receptor concentrations); indicators based on ferritin and/or transferrin receptor will be restricted to those without inflammation.
Measured: At 1 month after delivery
Maternal intestinal pathogens
Measured: At 1 month after delivery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Mar 2011 (estimated)
- Study startOct 2011
- Primary completionApr 2013
- Study completionMay 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)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 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 470 participants (actual)
Sponsor and investigators
- Lead sponsor
- London School of Hygiene and Tropical Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- University of Nairobi, Wageningen University
- Responsible party
- Sponsor
- Investigators
- Hans Verhoef, PhD, Principal investigator, London School of Hygiene and Tropical Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01308112
- Sponsor's protocol ID
- LSHTM-5664
- Acronym
- PIMAL
- Status last verified
- May 2013
- First submitted
- 2 Mar 2011
- Last updated
- 29 May 2013
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Mwangi MN, Roth JM, Smit MR, Trijsburg L, Mwangi AM, Demir AY, Wielders JP, Mens PF, Verweij JJ, Cox SE, Prentice AM, Brouwer ID, Savelkoul HF, Andang'o PE, Verhoef H. Effect of Daily Antenatal Iron Supplementation on Plasmodium Infection in Kenyan Women: A Randomized Clinical Trial. JAMA. 2015 Sep 8;314(10):1009-20. doi: 10.1001/jama.2015.9496.
PubMed 26348751Mwangi MN, Maskey S, Andang o PE, Shinali NK, Roth JM, Trijsburg L, Mwangi AM, Zuilhof H, van Lagen B, Savelkoul HF, Demir AY, Verhoef H. Diagnostic utility of zinc protoporphyrin to detect iron deficiency in Kenyan pregnant women. BMC Med. 2014 Nov 26;12:229. doi: 10.1186/s12916-014-0229-8.
PubMed 25428714
Study at a glance
From the registry record, last updated by the sponsor on 29 May 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomised Trial to Assess the Safety and Efficacy or Iron Supplementation in Kenyan Pregnant Women
- ClinicalTrials.gov ID
- NCT01308112
- Acronym / sponsor ID
- PIMAL / LSHTM-5664
- Conditions
- Malaria
- Keywords
- Iron, Plasmodium, Malaria, Pregnancy, Kenya
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 470 participants (actual)
- Lead sponsor
- London School of Hygiene and Tropical MedicineUniversity, hospital or other
- Collaborators
- University of Nairobi, Wageningen University
- Study start
- Oct 2011
- Primary completion
- Apr 2013 (actual)
- Study completion
- May 2013 (actual)
- First posted
- 3 Mar 2011 (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 compare the presence of Plasmodium infection in parturient women who antenatally received a combination of iron-fortified foods with iron supplements versus iron-fortified foods only.
Detailed description
As per recommendations by the World Health Organization (WHO), iron supplementation in children should be restricted in malaria-endemic areas because of concerns that it can lead to an increased burden of malaria. Universal iron supplementation continues to be recommended, however, for women during pregnancy and 3 months postpartum. Observational studies have shown that iron deficiency in parturient women is associated with a marked reduction in the prevalence and density of malarial parasites in the placenta. Plasmodium infections in pregnant women have devastating effects on the foetus and neonate, causing low birth weight, intrauterine growth retardation, preterm delivery, spontaneous abortion, stillbirth and neonatal mortality. Based on our previous work, the Kenyan government is currently drafting legislation for mandatory iron fortification of industrially milled flour. Implementation of the new fortification policy means that pregnant women will receive iron through a combination of fortified foods and supplementation. The investigators are concerned about the safety of the high iron intake resulting from such a policy.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Supplemental iron | Experimental | Dietary Supplement: iron |
| Placebo | Placebo comparator | Dietary Supplement: iron |
Who may qualify
- Ages
- 15 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (2 listed)
- Women aged 15-45 years resident in the predefined study area
- Pregnant, with gestational age <23 weeks
Key exclusion criteria (9 listed)
- Failure to provide a blood sample
- Initial haemoglobin concentration <90 g/L
- Reported medical history suggestive of sickle cell anaemia, epilepsy, diabetes
- Obstetric history suggestive of eclampsia or pre-eclampsia
- Obvious mental retardation or metabolic disorder;
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 |
|---|---|---|
| ironDaily supplementation with iron (60 mg) as ferrous sulphate | Dietary supplement | Placebo, Supplemental iron |
Primary outcome
Maternal Plasmodium infection
Time frame: Parturition
Assessed by LDH- and HRP2-based dipstick test and PCR
4 secondary outcomes
Serum non-transferrin bound iron concentration
Time frame: 3 h after ingestion of first supplement with either iron or placebo
Neonatal iron stores
Time frame: At 1 month of age
Maternal iron status
Time frame: At 1 month after delivery
Maternal intestinal pathogens
Time frame: At 1 month after delivery
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 29 May 2013.
- Derived from this study: PubMed 26348751Mwangi MN, Roth JM, Smit MR, Trijsburg L, Mwangi AM, Demir AY, Wielders JP, Mens PF, Verweij JJ, Cox SE, Prentice AM, Brouwer ID, Savelkoul HF, Andang'o PE, Verhoef H. Effect of Daily Antenatal Iron Supplementation on Plasmodium Infection in Kenyan Women: A Randomized Clinical Trial. JAMA. 2015 Sep 8;314(10):1009-20. doi: 10.1001/jama.2015.9496.
- Derived from this study: PubMed 25428714Mwangi MN, Maskey S, Andang o PE, Shinali NK, Roth JM, Trijsburg L, Mwangi AM, Zuilhof H, van Lagen B, Savelkoul HF, Demir AY, Verhoef H. Diagnostic utility of zinc protoporphyrin to detect iron deficiency in Kenyan pregnant women. BMC Med. 2014 Nov 26;12:229. doi: 10.1186/s12916-014-0229-8.
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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.
Hans Verhoef, PhD principal investigator
London School of Hygiene and Tropical Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing iron in people with Malaria, run by London School of Hygiene and Tropical Medicine at 1 site in Kenya.
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 9 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 29 May 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 Kenya. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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?
Maternal Plasmodium infection (time frame: Parturition). 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 NCT01308112, which also lists 2 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 29 May 2013.