PregnancyNCT03079388
Nutritional and Anti-infective Interventions for Malnutrition in Pregnancy (Beleuman Welbodi)
A study testing Ready-to-use-supplementary food, Corn-soy-blend and Monthly intermittent preventive treatment of malaria during pregnancy (IPTp) in people with Pregnancy and Malnutrition in Pregnancy, run by Washington University School of Medicine at 1 site in Sierra Leone.
Trial summary
Acute malnutrition in pregnancy is a risk factor for adverse outcomes in mothers and their unborn children. Undernutrition during pregnancy can result in maternal complications such as life-threatening hemorrhage and hypertensive disorders of pregnancy and infant complications such as intrauterine growth retardation… Read more about this study
- Who is it for?
- Ages 14 years and older, women only
- Conditions the study is for
- Pregnancy, Malnutrition in Pregnancy, Nutrition Disorders
- What is being tested?
- Ready-to-use-supplementary food, Corn-soy-blend and Monthly intermittent preventive treatment of malaria during pregnancy (IPTp)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,489 participants
- Where
- 1 siteSierra Leone
- Study dates
- 27 Feb 2017to 24 Feb 2020
- 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 women and consenting to study participation
- Fundal height not greater than 32 cm
- Mid-upper arm circumference ≤23 cm
- Planning to reside in the study area during pregnancy and 6 months post partum
- Attending 1 of the 40 antenatal clinic sites
Who cannot join
- < 16 years of age without adult willing to consent
- Known pregnancy complications such as gestational diabetes, pre-eclampsia, hypertension
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Randomized Control Trial of the Use of Supplementary Food and Measures to Control Inflammation in Malnourished Pregnant Women to Improve Birth Outcomes
Acute malnutrition in pregnancy is a risk factor for adverse outcomes in mothers and their unborn children. Undernutrition during pregnancy can result in maternal complications such as life-threatening hemorrhage and hypertensive disorders of pregnancy and infant complications such as intrauterine growth retardation, low birth weight, pre-term delivery and poor cognitive development. Poor women in the developing world are at heightened risk of malnutrition due to inadequate dietary intake and are subject to transmission of a number of infections including malaria, intestinal helminths, and genitourinary infections. Food interventions for malnutrition may be less effective under conditions with excessive inflammation and infection, and especially so during pregnancy. Without specifically addressing treatment for infections, undernourished mothers may be less responsive to nutritional interventions. The benefits of treating both malnutrition and common infections simultaneously remain largely unstudied. This study tests the hypothesis that malnourished pregnant women receiving 100 grams per day of a specially formulated ready-to-use supplementary food in addition to a combination of 5 anti-infective interventions will have greater weight gain in pregnancy and deliver larger, longer infants than women receiving the standard of care. The outcome of the pregnancy and maternal nutritional status will be followed until 6 months after delivery.
- Conditions
- Pregnancy, Malnutrition in Pregnancy, Nutrition Disorders, Stunting
- Being tested
- Ready-to-use-supplementary food, Corn-soy-blend, Monthly intermittent preventive treatment of malaria during pregnancy (IPTp), Standard intermittent preventive treatment of malaria during pregnancy (IPTp), Insecticide-treated mosquito net
- Medical subject headings
- Nutrition Disorders, Growth Disorders
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
Specially formulated supplementary food for pregnancy
Corn-soy-blendDietary supplement
Standard of care for malnutrition in pregnancy in Sierra Leone
Monthly intermittent preventive treatment of malaria during pregnancy (IPTp)Drug
Also called Sulfadoxine-pyrimethamine
Sulfadoxine-pyrimethamine (500 mg / 25 mg) given every 4 weeks, beginning at enrollment or at 13 weeks' gestation, whichever is later.
Standard intermittent preventive treatment of malaria during pregnancy (IPTp)Drug
Also called Sulfadoxine-pyrimethamine
Standard of care for Sierra Leone is 2 doses of sulfadoxine/ pyrimethamine (500mg/ 25mg).
Insecticide-treated mosquito netOther
An insecticide-treated mosquito net at the time of enrollment into the study.
AzithromycinDrug
Azithromycin 1 gram given once in second trimester and again during weeks 28-34 of gestation.
AlbendazoleDrug
Single dose albendazole 400mg given in the second trimester.
Bacterial vaginosis testing and treatmentCombination product
Testing for bacterial vaginosis at enrollment and again at weeks 28-34 using a rapid diagnostic test for sialidase. Those with positive tests will receive extended release metronidazole 750mg daily for 7 days.
| Study group | Role | What they receive |
|---|---|---|
| Ready-to-use supplementary food + anti-infective bundle | Experimental | The women randomized to this arm will receive a ready-to-use-supplementary food (RUSF) designed specifically for pregnancy. The RUSF will provide a total of 520 kcal, 18 g protein, and 200% of recommended daily allowance (RDA) for most micronutrients during pregnancy. The supplement is also optimized to provide excellent protein quality and optimal polyunsaturated fatty acid composition. These women will receive 5 anti-infective interventions: 1) insecticide-treated mosquito net, 2) monthly intermittent preventive treatment of malaria during pregnancy (IPTp) 3) azithromycin at the second and third trimester 4) albendazole given in second trimester, and 5) bacterial vaginosis testing and treatment at enrollment and again at weeks 28-34 Receives: Dietary Supplement: Ready-to-use-supplementary food; Drug: Monthly intermittent preventive treatment of malaria during pregnancy (IPTp); Other: Insecticide-treated mosquito net; Drug: Azithromycin; Drug: Albendazole; Combination Product: Bacterial vaginosis testing and treatment |
| Corn-soy-blend | Active comparator | The women randomized to this arm will receive the standard of care for Sierra Leone. The treatment provided to women in this group includes 3.5 kg super cereal with 350 g vegetable oil every two weeks. This provides 250 mg portion/day of the super cereal and 25g oil/day for the mother. Women will receive the food for the duration of their pregnancy. These women will receive the current recommendations of the government of Sierra Leone, which includes standard intermittent preventive treatment of malaria during pregnancy (IPTp) of 2 doses of sulfadoxine/ pyrimethamine, iron and folic acid supplement with a goal of 90 pills/pregnancy, an insecticide-treated mosquito net, and albendazole for deworming in the second trimester. Receives: Dietary Supplement: Corn-soy-blend; Drug: Standard intermittent preventive treatment of malaria during pregnancy (IPTp); Other: Insecticide-treated mosquito net; Drug: Albendazole |
What is being measured
The primary outcome is the main question the study is designed to answer.
Infant birth length
mean birth length of infants born to mothers in the study
Measured: up to 40 weeks
Secondary outcomes (8)
Maternal weight gain
Average weekly weight gain of women in the study
Measured: up to 40 weeks
Proportion recovered from maternal malnutrition
proportion of women who reach mid-upper-arm circumference (MUAC) > 23 cm
Measured: up to 40 weeks
Premature delivery
proportion of infants born prematurely
Measured: up to 36 weeks
Newborn head circumference
mean head circumference of infants born to women in the study
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 weight at 6 weeks, 3 and 6 months
infant ponderal growth
Measured: up to 6 months
Infant length at 6 weeks, 3 and 6 months
infant linear growth
Measured: up to 6 months
Infant survival at 3 and 6 months
survival of infants in the study
Measured: 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 posted14 Mar 2017
- Study start27 Feb 2017
- Primary completion24 Sep 2019
- Study completion24 Feb 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)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
- 1,489 participants (actual)
Sponsor and investigators
- Lead sponsor
- Washington University School of Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- The Children's Investment Fund Foundation
- Responsible party
- Sponsor
- Investigators
- Mark J Manary, MD, Study chair, Washington University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03079388
- Sponsor's protocol ID
- 201611119
- Status last verified
- Jan 2021
- First submitted
- 5 Mar 2017
- Last updated
- 7 Jan 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Hendrixson DT, Lasowski PN, Koroma AS, Manary MJ. Newborn Mid-Upper Arm Circumference Identifies Low-Birth Weight and Vulnerable Infants: A Secondary Analysis. Curr Dev Nutr. 2022 Sep 12;6(10):nzac138. doi: 10.1093/cdn/nzac138. eCollection 2022 Oct.
PubMed 36475019Hendrixson DT, Smith K, Lasowski P, Callaghan-Gillespie M, Weber J, Papathakis P, Iversen PO, Koroma AS, Manary MJ. A novel intervention combining supplementary food and infection control measures to improve birth outcomes in undernourished pregnant women in Sierra Leone: A randomized, controlled clinical effectiveness trial. PLoS Med. 2021 Sep 28;18(9):e1003618. doi: 10.1371/journal.pmed.1003618. eCollection 2021 Sep.
PubMed 34582451Hendrixson DT, Koroma AS, Callaghan-Gillespie M, Weber J, Papathakis P, Manary MJ. Use of a novel supplementary food and measures to control inflammation in malnourished pregnant women in Sierra Leone to improve birth outcomes: study protocol for a prospective, randomized, controlled clinical effectiveness trial. BMC Nutr. 2018 Apr 2;4:15. doi: 10.1186/s40795-018-0218-y. eCollection 2018.
PubMed 32153879
Study at a glance
From the registry record, last updated by the sponsor on 7 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Control Trial of the Use of Supplementary Food and Measures to Control Inflammation in Malnourished Pregnant Women to Improve Birth Outcomes
- ClinicalTrials.gov ID
- NCT03079388
- Acronym / sponsor ID
- 201611119
- Conditions
- Pregnancy, Malnutrition in Pregnancy, Nutrition Disorders, Stunting
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,489 participants (actual)
- Lead sponsor
- Washington University School of MedicineUniversity, hospital or other
- Collaborators
- The Children's Investment Fund Foundation
- Study start
- 27 Feb 2017 (actual)
- Primary completion
- 24 Sep 2019 (actual)
- Study completion
- 24 Feb 2020 (actual)
- First posted
- 14 Mar 2017 (actual)
- 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.
Acute malnutrition in pregnancy is a risk factor for adverse outcomes in mothers and their unborn children. Undernutrition during pregnancy can result in maternal complications such as life-threatening hemorrhage and hypertensive disorders of pregnancy and infant complications such as intrauterine growth retardation, low birth weight, pre-term delivery and poor cognitive development. Poor women in the developing world are at heightened risk of malnutrition due to inadequate dietary intake and are subject to transmission of a number of infections including malaria, intestinal helminths, and genitourinary infections. Food interventions for malnutrition may be less effective under conditions with excessive inflammation and infection, and especially so during pregnancy. Without specifically addressing treatment for infections, undernourished mothers may be less responsive to nutritional interventions. The benefits of treating both malnutrition and common infections simultaneously remain largely unstudied. This study tests the hypothesis that malnourished pregnant women receiving 100 grams per day of a specially formulated ready-to-use supplementary food in addition to a combination of 5 anti-infective interventions will have greater weight gain in pregnancy and deliver larger, longer infants than women receiving the standard of care. The outcome of the pregnancy and maternal nutritional status will be followed until 6 months after delivery.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ready-to-use supplementary food + anti-infective bundle | Experimental | Dietary Supplement: Ready-to-use-supplementary food, Drug: Monthly intermittent preventive treatment of malaria during pregnancy (IPTp), Other: Insecticide-treated mosquito net, Drug: Azithromycin, Drug: Albendazole, Combination Product: Bacterial vaginosis testing and treatmentThe women randomized to this arm will receive a ready-to-use-supplementary food (RUSF) designed specifically for pregnancy. The RUSF will provide a total of 520 kcal, 18 g protein, and 200% of recommended daily allowance (RDA) for most micronutrients during pregnancy. The supplement is also optimized to provide excellent protein quality and optimal polyunsaturated fatty acid composition. These women will receive 5 anti-infective interventions: 1) insecticide-treated mosquito net, 2) monthly intermittent preventive treatment of malaria during pregnancy (IPTp) 3) azithromycin at the second and third trimester 4) albendazole given in second trimester, and 5) bacterial vaginosis testing and treatment at enrollment and again at weeks 28-34 |
| Corn-soy-blend | Active comparator | Dietary Supplement: Corn-soy-blend, Drug: Standard intermittent preventive treatment of malaria during pregnancy (IPTp), Other: Insecticide-treated mosquito net, Drug: AlbendazoleThe women randomized to this arm will receive the standard of care for Sierra Leone. The treatment provided to women in this group includes 3.5 kg super cereal with 350 g vegetable oil every two weeks. This provides 250 mg portion/day of the super cereal and 25g oil/day for the mother. Women will receive the food for the duration of their pregnancy. These women will receive the current recommendations of the government of Sierra Leone, which includes standard intermittent preventive treatment of malaria during pregnancy (IPTp) of 2 doses of sulfadoxine/ pyrimethamine, iron and folic acid supplement with a goal of 90 pills/pregnancy, an insecticide-treated mosquito net, and albendazole for deworming in the second trimester. |
Who may qualify
- Ages
- 14 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- Pregnant women and consenting to study participation
- Fundal height not greater than 32 cm
- Mid-upper arm circumference ≤23 cm
- Planning to reside in the study area during pregnancy and 6 months post partum
- Attending 1 of the 40 antenatal clinic sites
Key exclusion criteria (2 listed)
- < 16 years of age without adult willing to consent
- Known pregnancy complications such as gestational diabetes, pre-eclampsia, hypertension
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 foodSpecially formulated supplementary food for pregnancy | Dietary supplement | Ready-to-use supplementary food + anti-infective bundle |
| Corn-soy-blendStandard of care for malnutrition in pregnancy in Sierra Leone | Dietary supplement | Corn-soy-blend |
| Monthly intermittent preventive treatment of malaria during pregnancy (IPTp)Also: Sulfadoxine-pyrimethamineSulfadoxine-pyrimethamine (500 mg / 25 mg) given every 4 weeks, beginning at enrollment or at 13 weeks' gestation, whichever is later. | Drug | Ready-to-use supplementary food + anti-infective bundle |
| Standard intermittent preventive treatment of malaria during pregnancy (IPTp)Also: Sulfadoxine-pyrimethamineStandard of care for Sierra Leone is 2 doses of sulfadoxine/ pyrimethamine (500mg/ 25mg). | Drug | Corn-soy-blend |
| Insecticide-treated mosquito netAn insecticide-treated mosquito net at the time of enrollment into the study. | Other | Corn-soy-blend, Ready-to-use supplementary food + anti-infective bundle |
| AzithromycinAzithromycin 1 gram given once in second trimester and again during weeks 28-34 of gestation. | Drug | Ready-to-use supplementary food + anti-infective bundle |
| AlbendazoleSingle dose albendazole 400mg given in the second trimester. | Drug | Corn-soy-blend, Ready-to-use supplementary food + anti-infective bundle |
| Bacterial vaginosis testing and treatmentTesting for bacterial vaginosis at enrollment and again at weeks 28-34 using a rapid diagnostic test for sialidase. Those with positive tests will receive extended release metronidazole 750mg daily for 7 days. | Combination product | Ready-to-use supplementary food + anti-infective bundle |
Primary outcome
Infant birth length
Time frame: up to 40 weeks
mean birth length of infants born to mothers in the study
8 secondary outcomes
Maternal weight gain
Time frame: up to 40 weeks
Proportion recovered from maternal malnutrition
Time frame: up to 40 weeks
Premature delivery
Time frame: up to 36 weeks
Newborn head circumference
Time frame: up to 40 weeks
Infant birth weight
Time frame: up to 40 weeks
Infant weight at 6 weeks, 3 and 6 months
Time frame: up to 6 months
Infant length at 6 weeks, 3 and 6 months
Time frame: up to 6 months
Infant survival at 3 and 6 months
Time frame: 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 7 Jan 2021.
- Derived from this study: PubMed 36475019Hendrixson DT, Lasowski PN, Koroma AS, Manary MJ. Newborn Mid-Upper Arm Circumference Identifies Low-Birth Weight and Vulnerable Infants: A Secondary Analysis. Curr Dev Nutr. 2022 Sep 12;6(10):nzac138. doi: 10.1093/cdn/nzac138. eCollection 2022 Oct.
- Derived from this study: PubMed 34582451Hendrixson DT, Smith K, Lasowski P, Callaghan-Gillespie M, Weber J, Papathakis P, Iversen PO, Koroma AS, Manary MJ. A novel intervention combining supplementary food and infection control measures to improve birth outcomes in undernourished pregnant women in Sierra Leone: A randomized, controlled clinical effectiveness trial. PLoS Med. 2021 Sep 28;18(9):e1003618. doi: 10.1371/journal.pmed.1003618. eCollection 2021 Sep.
- Derived from this study: PubMed 32153879Hendrixson DT, Koroma AS, Callaghan-Gillespie M, Weber J, Papathakis P, Manary MJ. Use of a novel supplementary food and measures to control inflammation in malnourished pregnant women in Sierra Leone to improve birth outcomes: study protocol for a prospective, randomized, controlled clinical effectiveness trial. BMC Nutr. 2018 Apr 2;4:15. doi: 10.1186/s40795-018-0218-y. eCollection 2018.
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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 School of Medicine
1 site 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 Monthly intermittent preventive treatment of malaria during pregnancy (IPTp) in people with Pregnancy and Malnutrition in Pregnancy, run by Washington University School of Medicine at 1 site in Sierra Leone.
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 5 inclusion and 2 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 7 Jan 2021. 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 Sierra Leone. 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?
Infant birth length (time frame: up to 40 weeks). 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 NCT03079388, which also lists 3 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 7 Jan 2021.