Malnutrition, ChildNCT04216043

Milk Matters in Malnutrition, is it the Lactose or Dairy Protein?

A study testing RUSF skimmed milk powder, RUSF milk protein concentrate and sucrose and RUSF soy protein and whey permeate in people with Malnutrition, Child, run by Washington University School of Medicine at 1 site in Sierra Leone.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

This study is to look at the types of sugar and protein composition in the treatment of moderate acute malnutrition and its effects on gut health. The study will use 4 different types of ready to use supplementary foods to see which one if any has better recovery rate along with looking into the gut health. Read more about this study

Who is it for?: Ages 6 to 59 months
Conditions the study is for: Malnutrition, Child
What is being tested?: RUSF skimmed milk powder, RUSF milk protein concentrate and sucrose and RUSF soy protein and whey permeate
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 1,102 participants
Where: 1 siteSierra Leone
Study dates: 16 Sep 2020to 7 Mar 2022
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 6 to 59 months
All sexes
No healthy volunteers
Child

Who may be able to join

MUAC < 12.5 cm and ≥ 11.5 cm without bipedal oedema

Who cannot join

If they are involved in another research trial
in another supplemental feeding program
debilitating illness
history of peanut or milk allergy

Trial locations and contacts

1 site in 1 country.

Sierra Leone1 site

Project Peanut Butter Factory
Freetown

Other trials in Sierra Leone

About this study

Conditions: Malnutrition, Child
Being tested: RUSF skimmed milk powder, RUSF milk protein concentrate and sucrose, RUSF soy protein and whey permeate, RUSF soy and sucrose
Medical subject headings: Child Nutrition Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

RUSF skimmed milk powderDietary supplement
ready-to-use supplementary foods 75 kcal/kg/day (314 kJ/kg/day) and full daily doses of vitamins and micronutrients
RUSF milk protein concentrate and sucroseDietary supplement
ready-to-use supplementary foods 75 kcal/kg/day (314 kJ/kg/day) and full daily doses of vitamins and micronutrients
RUSF soy protein and whey permeateDietary supplement
ready-to-use supplementary foods 75 kcal/kg/day (314 kJ/kg/day) and full daily doses of vitamins and micronutrients
RUSF soy and sucroseDietary supplement
ready-to-use supplementary foods 75 kcal/kg/day (314 kJ/kg/day) and full daily doses of vitamins and micronutrients

Study groups in NCT04216043
Study group	Role	What they receive
RUSF skimmed milk powder	Experimental	RUSF will provide 75 kcal/kg/day (314 kJ/kg/day) and full daily doses of vitamins and micronutrients. Caregivers will instruct caregivers to feed the supplement only to the enrolled child, to feed it in addition to their usual diet, and to use daily portions. Receives: Dietary Supplement: RUSF skimmed milk powder
RUSF milk protein concentrate and sucrose	Experimental	RUSF will provide 75 kcal/kg/day (314 kJ/kg/day) and full daily doses of vitamins and micronutrients. Caregivers will instruct caregivers to feed the supplement only to the enrolled child, to feed it in addition to their usual diet, and to use daily portions. Receives: Dietary Supplement: RUSF milk protein concentrate and sucrose
RUSF soy protein and whey permeate	Experimental	RUSF will provide 75 kcal/kg/day (314 kJ/kg/day) and full daily doses of vitamins and micronutrients. Caregivers will instruct caregivers to feed the supplement only to the enrolled child, to feed it in addition to their usual diet, and to use daily portions. Receives: Dietary Supplement: RUSF soy protein and whey permeate
RUSF soy and sucrose	Experimental	RUSF will provide 75 kcal/kg/day (314 kJ/kg/day) and full daily doses of vitamins and micronutrients. Caregivers will instruct caregivers to feed the supplement only to the enrolled child, to feed it in addition to their usual diet, and to use daily portions. Receives: Dietary Supplement: RUSF soy and sucrose

What is being measured

The primary outcome is the main question the study is designed to answer.

% lactulose excretion after 4 weeks of supplementary feeding
This will only be assessed in children with higher-risk (MUAC < 12 cm) MAM at baseline.
%L measured in the urine relative to the amount ingested will be calculated. %L will be categorized as normal (<0.2%) and abnormal (>0.2)
Measured: 4 weeks
16S rRNA relative abundance of bacterial taxa after 4 weeks of supplementary feeding
This will only be assessed in children with higher-risk (MUAC < 12 cm) MAM at baseline
Measured: 4 weeks

Secondary outcomes (11)

Rate of weight gain (g/kg/d)
Changes in weight relative to baseline weight
Measured: up to 12 weeks of treatment
Rate of length gain (mm/week)
Changes in linear growth
Measured: up to 12 weeks of treatment
Final mid-upper arm circumference
Use the mid-upper are circumference at the visit when outcome was reached
Measured: up to 12 weeks of treatment
Proportion with %L < 0.20
Percentage of children with %L excreted < 0.20
Measured: 4 weeks
16S rRNA beta-diversity at week 4
Looking at the 16S configuration in stool samples collected
Measured: 4 weeks
16S rRNA alpha-diversity at week 4
Several metrics of alpha diversity will be assessed, including Shannon's index
Measured: 4 weeks
Rate of recovery from moderate acute malnutrition
Recovery is when a participant reaches a Mid-Upper Arm Circumference of 12.5cm or better
Measured: up to 12 weeks of treatment
Rate of deteriorating to severe acute malnutrition or death
Severe acute malnutrition defined by MUAC < 11.5 cm or development of nutritional edema
Measured: up to 12 weeks of treatment
Sub-group analysis of %L and 16S rRNA outcomes among children not receiving breastfeeding at baseline vs. those being breastfeed at baseline
Anthropometric, %L and 16s rRNA outcomes (relative abundance, alpha-diversity, beta-diversity) will be compared between study foods among those who are reported to be breastfeeding vs. those who are not
Measured: 4 weeks
Sub-group analysis of anthropometric outcomes among children with MUAC < 12 cm vs. >= 12 cm at baseline
Rate of weight change, length change, final MUAC, recovery, SAM, and death will be compared between the study foods among children with baseline MUAC < vs. >=12 cm.
Measured: up to 12 weeks of treatment
Metabolomic feature abundance in the 4 dietary groups
Metabolomic feature abundance in the 4 dietary groups, as determined by untargeted metabolomics in 200 randomly selected children with MUAC < 12.1 cm on enrollment
Measured: After 4 weeks of supplementary feeding

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

16 Sep 20207 Mar 2022

First posted2 Jan 2020
Study start16 Sep 2020
Primary completion7 Mar 2022
Study completion7 Mar 2022

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (6)Papers the sponsor has linked to this study.
Other trials for Malnutrition, ChildStudies 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: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 1,102 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04216043
Sponsor's protocol ID: 201912091
Status last verified: Jan 2024
First submitted: 23 Dec 2019
Last updated: 5 Jan 2024
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No

Publications

Black RE, Allen LH, Bhutta ZA, Caulfield LE, de Onis M, Ezzati M, Mathers C, Rivera J; Maternal and Child Undernutrition Study Group. Maternal and child undernutrition: global and regional exposures and health consequences. Lancet. 2008 Jan 19;371(9608):243-60. doi: 10.1016/S0140-6736(07)61690-0. No abstract available.
PubMed 18207566
Caulfield LE, de Onis M, Blossner M, Black RE. Undernutrition as an underlying cause of child deaths associated with diarrhea, pneumonia, malaria, and measles. Am J Clin Nutr. 2004 Jul;80(1):193-8. doi: 10.1093/ajcn/80.1.193.
PubMed 15213048
Shankar AH. Nutritional modulation of malaria morbidity and mortality. J Infect Dis. 2000 Sep;182 Suppl 1:S37-53. doi: 10.1086/315906.
PubMed 10944483
Matilsky DK, Maleta K, Castleman T, Manary MJ. Supplementary feeding with fortified spreads results in higher recovery rates than with a corn/soy blend in moderately wasted children. J Nutr. 2009 Apr;139(4):773-8. doi: 10.3945/jn.108.104018. Epub 2009 Feb 18.
PubMed 19225128
Nackers F, Broillet F, Oumarou D, Djibo A, Gaboulaud V, Guerin PJ, Rusch B, Grais RF, Captier V. Effectiveness of ready-to-use therapeutic food compared to a corn/soy-blend-based pre-mix for the treatment of childhood moderate acute malnutrition in Niger. J Trop Pediatr. 2010 Dec;56(6):407-13. doi: 10.1093/tropej/fmq019. Epub 2010 Mar 23.
PubMed 20332221
Son M, Laury ML, Stephenson KB, May T, Hendrixson DT, Koroma AS, Ngegbai AS, Song JH, Naskidashvili N, Goo YA, Manary MJ. The Impact of Milk on Gut Permeability, Fecal 16S rRNA Gene Microbiota Profiling, and Fecal Metabolomics in Children with Moderate Malnutrition in Sierra Leone: A Double-Blind, Randomized Controlled Trial. Am J Clin Nutr. 2024 Nov;120(5):1114-1124. doi: 10.1016/j.ajcnut.2024.09.018. Epub 2024 Sep 21.
PubMed 39307188

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Malnutrition, Child trials

Study at a glance

From the registry record, last updated by the sponsor on 5 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Milk Matters in Malnutrition, is it the Lactose or Dairy Protein?
ClinicalTrials.gov ID: NCT04216043
Acronym / sponsor ID: 201912091
Conditions: Malnutrition, Child
Study type: Interventional
Recruitment status: Completed
Enrolment: 1,102 participants (actual)
Lead sponsor: Washington University School of MedicineUniversity, hospital or other
Collaborators: Project Peanut Butter, Sierra Leone
Study start: 16 Sep 2020 (actual)
Primary completion: 7 Mar 2022 (actual)
Study completion: 7 Mar 2022 (actual)
First posted: 2 Jan 2020 (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.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 4

Arm	Type	Receives
RUSF skimmed milk powder	Experimental	Dietary Supplement: RUSF skimmed milk powderRUSF will provide 75 kcal/kg/day (314 kJ/kg/day) and full daily doses of vitamins and micronutrients. Caregivers will instruct caregivers to feed the supplement only to the enrolled child, to feed it in addition to their usual diet, and to use daily portions.
RUSF milk protein concentrate and sucrose	Experimental	Dietary Supplement: RUSF milk protein concentrate and sucroseRUSF will provide 75 kcal/kg/day (314 kJ/kg/day) and full daily doses of vitamins and micronutrients. Caregivers will instruct caregivers to feed the supplement only to the enrolled child, to feed it in addition to their usual diet, and to use daily portions.
RUSF soy protein and whey permeate	Experimental	Dietary Supplement: RUSF soy protein and whey permeateRUSF will provide 75 kcal/kg/day (314 kJ/kg/day) and full daily doses of vitamins and micronutrients. Caregivers will instruct caregivers to feed the supplement only to the enrolled child, to feed it in addition to their usual diet, and to use daily portions.
RUSF soy and sucrose	Experimental	Dietary Supplement: RUSF soy and sucroseRUSF will provide 75 kcal/kg/day (314 kJ/kg/day) and full daily doses of vitamins and micronutrients. Caregivers will instruct caregivers to feed the supplement only to the enrolled child, to feed it in addition to their usual diet, and to use daily portions.

Who may qualify

Ages: 6 to 59 months
Sex: All
Healthy volunteers: Not accepted
Age groups: Child

Key inclusion criteria (1 listed)

MUAC < 12.5 cm and ≥ 11.5 cm without bipedal oedema

Key exclusion criteria (4 listed)

If they are involved in another research trial
in another supplemental feeding program
debilitating illness
history of peanut or milk allergy

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
RUSF skimmed milk powderready-to-use supplementary foods 75 kcal/kg/day (314 kJ/kg/day) and full daily doses of vitamins and micronutrients	Dietary supplement	RUSF skimmed milk powder
RUSF milk protein concentrate and sucroseready-to-use supplementary foods 75 kcal/kg/day (314 kJ/kg/day) and full daily doses of vitamins and micronutrients	Dietary supplement	RUSF milk protein concentrate and sucrose
RUSF soy protein and whey permeateready-to-use supplementary foods 75 kcal/kg/day (314 kJ/kg/day) and full daily doses of vitamins and micronutrients	Dietary supplement	RUSF soy protein and whey permeate
RUSF soy and sucroseready-to-use supplementary foods 75 kcal/kg/day (314 kJ/kg/day) and full daily doses of vitamins and micronutrients	Dietary supplement	RUSF soy and sucrose

Primary outcome

% lactulose excretion after 4 weeks of supplementary feeding
Time frame: 4 weeks
This will only be assessed in children with higher-risk (MUAC < 12 cm) MAM at baseline. %L measured in the urine relative to the amount ingested will be calculated. %L will be categorized as normal (<0.2%) and abnormal (>0.2)
16S rRNA relative abundance of bacterial taxa after 4 weeks of supplementary feeding
Time frame: 4 weeks
This will only be assessed in children with higher-risk (MUAC < 12 cm) MAM at baseline

11 secondary outcomes

Rate of weight gain (g/kg/d)
Time frame: up to 12 weeks of treatment
Rate of length gain (mm/week)
Time frame: up to 12 weeks of treatment
Final mid-upper arm circumference
Time frame: up to 12 weeks of treatment
Proportion with %L < 0.20
Time frame: 4 weeks
16S rRNA beta-diversity at week 4
Time frame: 4 weeks
16S rRNA alpha-diversity at week 4
Time frame: 4 weeks
Rate of recovery from moderate acute malnutrition
Time frame: up to 12 weeks of treatment
Rate of deteriorating to severe acute malnutrition or death
Time frame: up to 12 weeks of treatment
Sub-group analysis of %L and 16S rRNA outcomes among children not receiving breastfeeding at baseline vs. those being breastfeed at baseline
Time frame: 4 weeks
Sub-group analysis of anthropometric outcomes among children with MUAC < 12 cm vs. >= 12 cm at baseline
Time frame: up to 12 weeks of treatment
Metabolomic feature abundance in the 4 dietary groups
Time frame: After 4 weeks of supplementary feeding

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 5 Jan 2024.
Background: PubMed 18207566Black RE, Allen LH, Bhutta ZA, Caulfield LE, de Onis M, Ezzati M, Mathers C, Rivera J; Maternal and Child Undernutrition Study Group. Maternal and child undernutrition: global and regional exposures and health consequences. Lancet. 2008 Jan 19;371(9608):243-60. doi: 10.1016/S0140-6736(07)61690-0. No abstract available.
Background: PubMed 15213048Caulfield LE, de Onis M, Blossner M, Black RE. Undernutrition as an underlying cause of child deaths associated with diarrhea, pneumonia, malaria, and measles. Am J Clin Nutr. 2004 Jul;80(1):193-8. doi: 10.1093/ajcn/80.1.193.
Background: PubMed 10944483Shankar AH. Nutritional modulation of malaria morbidity and mortality. J Infect Dis. 2000 Sep;182 Suppl 1:S37-53. doi: 10.1086/315906.
Background: PubMed 19225128Matilsky DK, Maleta K, Castleman T, Manary MJ. Supplementary feeding with fortified spreads results in higher recovery rates than with a corn/soy blend in moderately wasted children. J Nutr. 2009 Apr;139(4):773-8. doi: 10.3945/jn.108.104018. Epub 2009 Feb 18.
Background: PubMed 20332221Nackers F, Broillet F, Oumarou D, Djibo A, Gaboulaud V, Guerin PJ, Rusch B, Grais RF, Captier V. Effectiveness of ready-to-use therapeutic food compared to a corn/soy-blend-based pre-mix for the treatment of childhood moderate acute malnutrition in Niger. J Trop Pediatr. 2010 Dec;56(6):407-13. doi: 10.1093/tropej/fmq019. Epub 2010 Mar 23.
Derived from this study: PubMed 39307188Son M, Laury ML, Stephenson KB, May T, Hendrixson DT, Koroma AS, Ngegbai AS, Song JH, Naskidashvili N, Goo YA, Manary MJ. The Impact of Milk on Gut Permeability, Fecal 16S rRNA Gene Microbiota Profiling, and Fecal Metabolomics in Children with Moderate Malnutrition in Sierra Leone: A Double-Blind, Randomized Controlled Trial. Am J Clin Nutr. 2024 Nov;120(5):1114-1124. doi: 10.1016/j.ajcnut.2024.09.018. Epub 2024 Sep 21.

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Milk Fat Globule Membrane-Enhanced RUTF for Children With Severe Acute Malnutrition
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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 Manary, MD principal investigator

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?

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 1 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 5 Jan 2024. 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?

% lactulose excretion after 4 weeks of supplementary feeding (time frame: 4 weeks). 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 NCT04216043, which also lists 6 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 5 Jan 2024.