PregnancyMamachipondeNCT02120599
Interventions for Moderate Malnutrition in Pregnancy
A study testing ready-to-use supplementary food, corn-soy blend and iron in people with Pregnancy and Moderate Malnutrition, run by Washington University School of Medicine at 2 sites in Malawi.
Trial summary
Malnutrition during pregnancy is more common in poor women in the developing world due to inadequate dietary intake combined with increased nutrient requirements; pregnancy risk is more consequential than among other demographic groups with increased risk of maternal and infant mortality and the lifelong effects of… Read more about this study
- Who is it for?
- Ages 14 years and older, women only
- Conditions the study is for
- Pregnancy, Moderate Malnutrition
- What is being tested?
- ready-to-use supplementary food, corn-soy blend and iron
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,867 participants
- Where
- 2 sitesMalawi
- Study dates
- Mar 2014to Aug 2016
- 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 14 years and older
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Pregnant and consenting to study participation and HIV testing (if not already performed)
- mid-upper-arm circumference (MUAC) ≤ 23 cm
- planning to stay in the area and attend the clinic during pregnancy and for 3 months post partum
Who cannot join
- Pregnancy complications such as gestational diabetes, pre-eclampsia, hypertension
- Severe anemia (Hg <7.0 mg/dl)
- Severe malnutrition
- under 18 years of age
- over estimated 35 weeks of gestation
Trial locations and contacts
2 sites in 1 country.
About this study
Official title: Randomized Controlled Trial of the Impact of Treating Moderately Malnourished Women in Pregnancy
Malnutrition during pregnancy is more common in poor women in the developing world due to inadequate dietary intake combined with increased nutrient requirements; pregnancy risk is more consequential than among other demographic groups with increased risk of maternal and infant mortality and the lifelong effects of fetal malnutrition. The benefits of treating moderate malnutrition during pregnancy remain largely undocumented. This study tests the hypothesis that providing either a fortified flour or fortified paste-based supplementary food designed to replete the nutrient deficits during pregnancy will result in improved maternal nutritional recovery rates and higher infant birth weights and lengths. This study is a randomized, controlled clinical trial of 3 supplementary foods in 1800 moderately malnourished Malawian women who are pregnant. Subjects will receive one of 3 food rations: 1) a ready-to-use supplementary food formulated to deliver about 200% of the recommended daily allowance (RDA) of most micronutrients in pregnancy (RUSF-P), 2) corn soy blend with a multiple micronutrient tablet chosen to deliver about 200% of the RDA of most micronutrients (CSB-P) or 3), the standard of care which is a corn soy blend with supplementary iron and folic acid (CSB), delivering between 0-350% of the RDA. Subjects will receive the supplementary food until they recover from MAM. The outcome of the pregnancy and maternal nutritional status will be followed until 3 months after delivery.
- Conditions
- Pregnancy, Moderate Malnutrition
- Being tested
- ready-to-use supplementary food, corn-soy blend, iron, folic acid, UNIMMAP
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ready-to-use supplementary foodDietary supplement
corn-soy blendDietary supplement
ironDietary supplement
folic acidDietary supplement
UNIMMAPDietary supplement
| Study group | Role | What they receive |
|---|---|---|
| corn-soy-blend | Active comparator | This is the control group for the study, which will receive the Malawi standard of care. The treatment provided to women randomized to this arm of the study includes daily iron (60 mg) and folic acid (400 mcg) supplementation, along with 4 kg/2 weeks corn-soy blend (~357 gm/d CSB). Receives: Dietary Supplement: corn-soy blend; Dietary Supplement: iron; Dietary Supplement: folic acid |
| corn-soy-blend + multiple micronutrients | Experimental | The treatment provided to women randomized to this arm of the study includes 200gm/d CSB along with a standard maternal multiple micronutrient tablet, which together provide a comparable amount of energy, protein and micronutrients to the ready-to-use supplemental food. The micronutrient supplement known as the United Nations Children's Emergency Fund (UNICEF) / World Health Organization (WHO) / United Nations University (UNU) international multiple micronutrient preparation (UNIMMAP) is widely available and has been used in many settings worldwide in pregnant women. Receives: Dietary Supplement: corn-soy blend; Dietary Supplement: UNIMMAP |
| ready-to-use supplementary food | Experimental | RUSF-P (ready-to-use supplementary food) provides 750 kcal/d, 20 g protein/d, and 200% of RDA/d for most micronutrients during pregnancy (except for vitamins A, B3, folic acid, minerals iodine, magnesium, and calcium which will remain near 100%) Receives: Dietary Supplement: ready-to-use supplementary food |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion recovered from moderate acute malnutrition (MAM)
proportion of women who reach mid-upper arm circumference (MUAC) > 23.5 cm for 2 consecutive visits
Measured: up to 40 weeks
Maternal change in mid-upper arm circumference (MUAC)
average change in mid-upper-arm circumference
Measured: up to 40 weeks
infant birth weight
mean birth weights of infants born to mothers in the study
Measured: up to 40 weeks
infant birth length
mean birth length of infants born to women in the study
Measured: up to 40 weeks
premature delivery
proportion of infants born prematurely
Measured: up to 36 weeks
Secondary outcomes (6)
maternal weight gain
Measured: up to 40 weeks
maternal hemoglobin
changes in average hemoglobin level
Measured: 8 weeks
pregnancy complications
rate of pregnancy complications
Measured: up to 40 weeks
infant weight at 3 months
Measured: 3 months
infant length at 3 months
Measured: 3 months
infant survival at 3 months
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Apr 2014 (estimated)
- Study startMar 2014
- Primary completionAug 2016
- Study completionAug 2016
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 PregnancyStudies of the same condition, open and under way.
- More trials run by Washington University School of MedicineThe sponsor's other registered studies.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 1,867 participants (actual)
Sponsor and investigators
- Lead sponsor
- Washington University School of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Mark J Manary, MD, Study chair, Washington University in St. Louis; University of MalawiPeggy C Papathakis, PhD, RD, Study director, California Polytechnic State University-San Luis ObispoKenneth Maleta, MBBS PhD, Principal investigator, University of MalawiChrissie Thakwalakwa, Principal investigator, University of Malawi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02120599
- Sponsor's protocol ID
- 201401112
- Acronym
- Mamachiponde
- Status last verified
- Nov 2016
- First submitted
- 18 Apr 2014
- Last updated
- 10 Nov 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
Callaghan-Gillespie M, Schaffner AA, Garcia P, Fry J, Eckert R, Malek S, Trehan I, Thakwalakwa C, Maleta KM, Manary MJ, Papathakis PC. Trial of ready-to-use supplemental food and corn-soy blend in pregnant Malawian women with moderate malnutrition: a randomized controlled clinical trial. Am J Clin Nutr. 2017 Oct 1;106(4):1062-1069. doi: 10.3945/ajcn.117.157198.
PubMed 28793991
Study at a glance
From the registry record, last updated by the sponsor on 10 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Controlled Trial of the Impact of Treating Moderately Malnourished Women in Pregnancy
- ClinicalTrials.gov ID
- NCT02120599
- Acronym / sponsor ID
- Mamachiponde / 201401112
- Conditions
- Pregnancy, Moderate Malnutrition
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,867 participants (actual)
- Lead sponsor
- Washington University School of MedicineUniversity, hospital or other
- Study start
- Mar 2014
- Primary completion
- Aug 2016 (actual)
- Study completion
- Aug 2016 (actual)
- First posted
- 23 Apr 2014 (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.
Malnutrition during pregnancy is more common in poor women in the developing world due to inadequate dietary intake combined with increased nutrient requirements; pregnancy risk is more consequential than among other demographic groups with increased risk of maternal and infant mortality and the lifelong effects of fetal malnutrition. The benefits of treating moderate malnutrition during pregnancy remain largely undocumented. This study tests the hypothesis that providing either a fortified flour or fortified paste-based supplementary food designed to replete the nutrient deficits during pregnancy will result in improved maternal nutritional recovery rates and higher infant birth weights and lengths. This study is a randomized, controlled clinical trial of 3 supplementary foods in 1800 moderately malnourished Malawian women who are pregnant. Subjects will receive one of 3 food rations: 1) a ready-to-use supplementary food formulated to deliver about 200% of the recommended daily allowance (RDA) of most micronutrients in pregnancy (RUSF-P), 2) corn soy blend with a multiple micronutrient tablet chosen to deliver about 200% of the RDA of most micronutrients (CSB-P) or 3), the standard of care which is a corn soy blend with supplementary iron and folic acid (CSB), delivering between 0-350% of the RDA. Subjects will receive the supplementary food until they recover from MAM. The outcome of the pregnancy and maternal nutritional status will be followed until 3 months after delivery.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| corn-soy-blend | Active comparator | Dietary Supplement: corn-soy blend, Dietary Supplement: iron, Dietary Supplement: folic acidThis is the control group for the study, which will receive the Malawi standard of care. The treatment provided to women randomized to this arm of the study includes daily iron (60 mg) and folic acid (400 mcg) supplementation, along with 4 kg/2 weeks corn-soy blend (~357 gm/d CSB). |
| corn-soy-blend + multiple micronutrients | Experimental | Dietary Supplement: corn-soy blend, Dietary Supplement: UNIMMAPThe treatment provided to women randomized to this arm of the study includes 200gm/d CSB along with a standard maternal multiple micronutrient tablet, which together provide a comparable amount of energy, protein and micronutrients to the ready-to-use supplemental food. The micronutrient supplement known as the United Nations Children's Emergency Fund (UNICEF) / World Health Organization (WHO) / United Nations University (UNU) international multiple micronutrient preparation (UNIMMAP) is widely available and has been used in many settings worldwide in pregnant women. |
| ready-to-use supplementary food | Experimental | Dietary Supplement: ready-to-use supplementary foodRUSF-P (ready-to-use supplementary food) provides 750 kcal/d, 20 g protein/d, and 200% of RDA/d for most micronutrients during pregnancy (except for vitamins A, B3, folic acid, minerals iodine, magnesium, and calcium which will remain near 100%) |
Who may qualify
- Ages
- 14 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Pregnant and consenting to study participation and HIV testing (if not already performed)
- mid-upper-arm circumference (MUAC) ≤ 23 cm
- planning to stay in the area and attend the clinic during pregnancy and for 3 months post partum
Key exclusion criteria (5 listed)
- Pregnancy complications such as gestational diabetes, pre-eclampsia, hypertension
- Severe anemia (Hg <7.0 mg/dl)
- Severe malnutrition
- under 18 years of age
- over estimated 35 weeks of gestation
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 |
|---|---|---|
| ready-to-use supplementary food | Dietary supplement | ready-to-use supplementary food |
| corn-soy blend | Dietary supplement | corn-soy-blend, corn-soy-blend + multiple micronutrients |
| iron | Dietary supplement | corn-soy-blend |
| folic acid | Dietary supplement | corn-soy-blend |
| UNIMMAP | Dietary supplement | corn-soy-blend + multiple micronutrients |
Primary outcome
Proportion recovered from moderate acute malnutrition (MAM)
Time frame: up to 40 weeks
proportion of women who reach mid-upper arm circumference (MUAC) > 23.5 cm for 2 consecutive visits
Maternal change in mid-upper arm circumference (MUAC)
Time frame: up to 40 weeks
average change in mid-upper-arm circumference
infant birth weight
Time frame: up to 40 weeks
mean birth weights of infants born to mothers in the study
infant birth length
Time frame: up to 40 weeks
mean birth length of infants born to women in the study
premature delivery
Time frame: up to 36 weeks
proportion of infants born prematurely
6 secondary outcomes
maternal weight gain
Time frame: up to 40 weeks
maternal hemoglobin
Time frame: 8 weeks
pregnancy complications
Time frame: up to 40 weeks
infant weight at 3 months
Time frame: 3 months
infant length at 3 months
Time frame: 3 months
infant survival at 3 months
Time frame: 3 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 10 Nov 2016.
- Derived from this study: PubMed 28793991Callaghan-Gillespie M, Schaffner AA, Garcia P, Fry J, Eckert R, Malek S, Trehan I, Thakwalakwa C, Maleta KM, Manary MJ, Papathakis PC. Trial of ready-to-use supplemental food and corn-soy blend in pregnant Malawian women with moderate malnutrition: a randomized controlled clinical trial. Am J Clin Nutr. 2017 Oct 1;106(4):1062-1069. doi: 10.3945/ajcn.117.157198.
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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.
Mark J Manary, MD study chair
Washington University in St. Louis; University of Malawi
Peggy C Papathakis, PhD, RD study director
California Polytechnic State University-San Luis Obispo
Kenneth Maleta, MBBS PhD principal investigator
University of Malawi
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ready-to-use supplementary food, corn-soy blend and iron in people with Pregnancy and Moderate Malnutrition, run by Washington University School of Medicine at 2 sites in Malawi.
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 10 Nov 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Malawi. 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.
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?
Proportion recovered from moderate acute malnutrition (MAM) (time frame: up to 40 weeks). The study lists 5 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 NCT02120599, 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 10 Nov 2016.