Acute Malnutrition in ChildhoodRAMPNCT07871955
The Relapse to Acute Malnutrition Prevention (RAMP) Trial
A study testing Azithromycin and Small-quantity Lipid-based Nutrient Supplements in people with Acute Malnutrition in Childhood and Acute Malnutrition, Severe, run by Action Against Hunger USA at 1 site in South Sudan.
Trial summary
This individually randomized controlled trial uses a 2x2 factorial design to evaluate the effects of azithromycin and small-quantity lipid-based nutrient supplements (SQ-LNS) on sustained nutritional recovery following initial recovery from uncomplicated severe acute malnutrition (SAM) in South Sudan. Read more about this study
- Who is it for?
- Ages 6 to 59 months
- Conditions the study is for
- Acute Malnutrition in Childhood, Acute Malnutrition, Severe
- What is being tested?
- Azithromycin and Small-quantity Lipid-based Nutrient Supplements
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 3,750 participants
- Where
- 1 siteSouth Sudan
- Study dates
- Oct 2026to Dec 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
Inclusion Criteria: Initial phase criteria (upon admission to SAM treatment)
- Age 6-44 months
- Diagnosed with uncomplicated SAM (MUAC < 11.5 cm and/or WHZ < -3 SD and/or bilateral pitting edema)
- Being admitted to an outpatient therapeutic program (OTP) at one of the outpatient treatment sites where the study is conducted
- Residing in the catchment area of a study OTP site with no plans to move elsewhere for the next 15 months.
- Provision of informed consent by a caregiver for the child's participation
Inclusion Criteria: Second phase criteria (upon discharge from SAM treatment)
- Age 6-47 months
- Determined to be recovered from SAM, defined as MUAC ≥ 12.5 cm, WHZ ≥ -2 SD, and no nutritional edema for two consecutive OTP visits
- Verification that the family plans to continue residing in the catchment area of a study site with no plans to move for next 12 months
- Verification of informed consent for the child's continued participation
- Agreement to return to the study site monthly for the next 12 months
- Agreement to be randomized to one of the four study arms and to provide their child with the randomized intervention(s)
Exclusion Criteria: Initial phase criteria (upon admission to SAM treatment)
- Age below 6 months or above 44 months
- Signs of severe illness requiring hospitalization
- Hospitalized prior to OTP admission (including in a stabilization center)
- Prior treatment for acute malnutrition within three months preceding study enrollment
Exclusion Criteria: Second phase criteria (upon discharge from SAM treatment)
- Age below 6 months or above 47 months
- Known allergies or contraindications to macrolide antibiotics
- Exited from OTP with a final discharge outcome as requiring hospitalization or defaulted
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
South Sudan1 site
Action Against Hunger USA
Gogrial West, Warrap
Stella Guwoly Henry, +211-926-640-008, gstella@ssd-actionagainsthunger.org
Heather Stobaugh
About this study
Official title: The RAMP Trial: Effectiveness of Azithromycin and Small-quantity Lipid-based Nutrient Supplements (SQ-LNS) on Sustained Nutritional Recovery Among Children Recovered From Uncomplicated Severe Acute Malnutrition in South Sudan
This individually randomized controlled trial uses a 2x2 factorial design to evaluate the effects of azithromycin and small-quantity lipid-based nutrient supplements (SQ-LNS) on sustained nutritional recovery following initial recovery from uncomplicated severe acute malnutrition (SAM) in South Sudan. The study will evaluate the effects of each intervention component alone and when given together, compared with standard care, on sustained recovery for 12 months post initial SAM recovery.
Read the detailed description
If there is a shortage of supply for one intervention or the another, we will enroll in the arms where we have supplies until all supplies are secured.
- Being tested
- Azithromycin, Placebo (Azithromycin), Small-quantity Lipid-based Nutrient Supplements
- Medical subject headings
- Severe Acute Malnutrition
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AzithromycinDrug
A single oral dose of 20mg/kg azithromycin will be administered under direct observation to children once every four weeks (with four weeks equaling one month of clinic services) for six monthly visits. It will be supplied as a 200 mg/5mL oral suspension reconstituted on-site and dosed using a calibrated dosing cup.
Placebo (Azithromycin)Drug
A single oral dose of matched placebo suspension equivalent to a 20mg/kg azithromycin dose will be administered under direct observation to children once every four weeks (with four weeks equaling one month of clinic services) at six monthly visits. It will be supplied as a 200 mg/5mL matched oral suspension reconstituted on-site and dosed using a calibrated dosing cup.
Small-quantity Lipid-based Nutrient SupplementsDietary supplement
One 20g sachet of SQ-LNS (120 kcal) will be provided daily consumption by children. It will be dispensed to caregivers as a monthly supply of 28 sachets at six monthly visits. (Four weeks equals one month of clinic services.) Open label.
| Study group | Role | What they receive |
|---|---|---|
| Control | Active comparator | Standard of care + placebo Receives: Drug: Placebo (Azithromycin) |
| RAMP Experimental A | Experimental | Azithromycin only Receives: Drug: Azithromycin |
| RAMP Experimental B | Experimental | SQ-LNS only Receives: Drug: Placebo (Azithromycin); Dietary Supplement: Small-quantity Lipid-based Nutrient Supplements |
| RAMP Experimental C | Experimental | Azithromycin + SQ-LNS Receives: Drug: Azithromycin; Dietary Supplement: Small-quantity Lipid-based Nutrient Supplements |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sustained nutritional recovery at 12 months post-recovery
Proportion of children who remained alive and achieved sustained nutritional recovery, defined as WHZ ≥ -2, MUAC ≥ 125mm, and no edema throughout the 12 months post-discharge.
Measured: Up to 12 months post-discharge
Secondary outcomes (11)
Sustained recovery at 6 months
Proportion of children who achieve sustained recovery at the end of the six-month intervention period.
Measured: 6 months post-discharge.
Cumulative incidence of relapse to acute malnutrition (AM)
Number of children who develop AM (MAM or SAM) during follow-up divided by total at risk at discharge.
Measured: Up to 12 months post-discharge
Cumulative incidence of relapse to MAM
Number of children who develop MAM during follow-up divided by total at risk at discharge.
Measured: Up to 12 months post-discharge
Cumulative incidence of relapse to SAM
Number of children who develop SAM during follow-up divided by total at risk at discharge.
Measured: Up to 12 months post-discharge
Cumulative mortality
Number of children who die during follow-up divided by total at risk at discharge.
Measured: Up to 12 months post-discharge
Weight gain velocity
Change in g/kg/day
Measured: Monthly for up to 12 months post-discharge
Change in MUAC
Change in cm
Measured: Monthly for up to 12 months post-discharge
Change in length/height
Change in cm
Measured: Monthly for up to 12 months post-discharge
Change in weight-for-height z-score (WHZ)
Change in WHZ calculated using the 2006 WHO Growth Standards
Measured: Monthly for up to 12 months post-discharge
Change in height-for-age z-score (HAZ)
Change in HAZ calculated using the 2006 WHO Growth Standards
Measured: Monthly for up to 12 months post-discharge
Change in weight-for-age z-score (WAZ)
Change in WAZ calculated using the 2006 WHO Growth Standards
Measured: Monthly for up to 12 months post-discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Oct 2026
- Study startOct 2026 (estimated)
- Primary completionDec 2028 (estimated)
- Study completionDec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Malnutrition in ChildhoodStudies 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
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 3,750 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Action Against Hunger USA
- Sponsor type
- University, hospital or other
- Collaborators
- University of Washington, Harvard School of Public Health (HSPH), Tufts University
- Responsible party
- Principal investigator, Heather Stobaugh, Action Against Hunger USA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07871955
- Sponsor's protocol ID
- RAMP Trial
- Acronym
- RAMP
- Status last verified
- Sep 2026
- First submitted
- 7 Oct 2026
- Last updated
- 13 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The RAMP Trial: Effectiveness of Azithromycin and Small-quantity Lipid-based Nutrient Supplements (SQ-LNS) on Sustained Nutritional Recovery Among Children Recovered From Uncomplicated Severe Acute Malnutrition in South Sudan
- ClinicalTrials.gov ID
- NCT07871955
- Acronym / sponsor ID
- RAMP / RAMP Trial
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 3,750 participants (estimated)
- Lead sponsor
- Action Against Hunger USAUniversity, hospital or other
- Collaborators
- University of Washington, Harvard School of Public Health (HSPH), Tufts University
- Study start
- Oct 2026 (estimated)
- Primary completion
- Dec 2028 (estimated)
- Study completion
- Dec 2028 (estimated)
- First posted
- 13 Oct 2026 (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.
This individually randomized controlled trial uses a 2x2 factorial design to evaluate the effects of azithromycin and small-quantity lipid-based nutrient supplements (SQ-LNS) on sustained nutritional recovery following initial recovery from uncomplicated severe acute malnutrition (SAM) in South Sudan. The study will evaluate the effects of each intervention component alone and when given together, compared with standard care, on sustained recovery for 12 months post initial SAM recovery.
Detailed description
If there is a shortage of supply for one intervention or the another, we will enroll in the arms where we have supplies until all supplies are secured.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Control | Active comparator | Drug: Placebo (Azithromycin)Standard of care + placebo |
| RAMP Experimental A | Experimental | Drug: AzithromycinAzithromycin only |
| RAMP Experimental B | Experimental | Drug: Placebo (Azithromycin), Dietary Supplement: Small-quantity Lipid-based Nutrient SupplementsSQ-LNS only |
| RAMP Experimental C | Experimental | Drug: Azithromycin, Dietary Supplement: Small-quantity Lipid-based Nutrient SupplementsAzithromycin + SQ-LNS |
Who may qualify
- Ages
- 6 to 59 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
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 |
|---|---|---|
| AzithromycinA single oral dose of 20mg/kg azithromycin will be administered under direct observation to children once every four weeks (with four weeks equaling one month of clinic services) for six monthly visits. It will be supplied as a 200 mg/5mL oral suspension reconstituted on-site and dosed using a calibrated dosing cup. | Drug | RAMP Experimental A, RAMP Experimental C |
| Placebo (Azithromycin)A single oral dose of matched placebo suspension equivalent to a 20mg/kg azithromycin dose will be administered under direct observation to children once every four weeks (with four weeks equaling one month of clinic services) at six monthly visits. It will be supplied as a 200 mg/5mL matched oral suspension reconstituted on-site and dosed using a calibrated dosing cup. | Drug | Control, RAMP Experimental B |
| Small-quantity Lipid-based Nutrient SupplementsOne 20g sachet of SQ-LNS (120 kcal) will be provided daily consumption by children. It will be dispensed to caregivers as a monthly supply of 28 sachets at six monthly visits. (Four weeks equals one month of clinic services.) Open label. | Dietary supplement | RAMP Experimental B, RAMP Experimental C |
Primary outcome
Sustained nutritional recovery at 12 months post-recovery
Time frame: Up to 12 months post-discharge
Proportion of children who remained alive and achieved sustained nutritional recovery, defined as WHZ ≥ -2, MUAC ≥ 125mm, and no edema throughout the 12 months post-discharge.
11 secondary outcomes
Sustained recovery at 6 months
Time frame: 6 months post-discharge.
Cumulative incidence of relapse to acute malnutrition (AM)
Time frame: Up to 12 months post-discharge
Cumulative incidence of relapse to MAM
Time frame: Up to 12 months post-discharge
Cumulative incidence of relapse to SAM
Time frame: Up to 12 months post-discharge
Cumulative mortality
Time frame: Up to 12 months post-discharge
Weight gain velocity
Time frame: Monthly for up to 12 months post-discharge
Change in MUAC
Time frame: Monthly for up to 12 months post-discharge
Change in length/height
Time frame: Monthly for up to 12 months post-discharge
Change in weight-for-height z-score (WHZ)
Time frame: Monthly for up to 12 months post-discharge
Change in height-for-age z-score (HAZ)
Time frame: Monthly for up to 12 months post-discharge
Change in weight-for-age z-score (WAZ)
Time frame: Monthly for up to 12 months post-discharge
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Oct 2026.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Azithromycin and Small-quantity Lipid-based Nutrient Supplements in people with Acute Malnutrition in Childhood and Acute Malnutrition, Severe, run by Action Against Hunger USA at 1 site in South Sudan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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: opening soon, as of the sponsor's last update on 13 Oct 2026. 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 South Sudan. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Heather Stobaugh, PhD (+1(212) 967-7800, researchteam@actionagainsthunger.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sustained nutritional recovery at 12 months post-recovery (time frame: Up to 12 months post-discharge). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 13 Oct 2026.