AzTrials
AzTrials

ChildPhase 4PREAMANCT01154595

Effectiveness of a Ready-to-Use-Food (RUF) Supplement to Prevent Acute Child Malnutrition

A Phase 4 study testing Plumpy Doz(r) - Ready-to-Use Food and Food-for-Training in people with Child and Malnutrition, run by Action Contre la Faim at 1 site in Chad.

Completed

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

Official record
Search all trials

Trial summary

The overall objective of this project is to assess the effectiveness and cost-effectiveness of RUF (ready-to-Use Food, Plumpy Doz(r)) to prevent moderate acute malnutrition in children aged 6-36 months if embedded in a program of conditional household food assistance. Read more about this study

Who is it for?
Ages 6 to 36 monthsHealthy volunteers can take part
Conditions the study is for
Child, Malnutrition
What is being tested?
Plumpy Doz(r) - Ready-to-Use Food and Food-for-Training
Could I receive a placebo?
No, everyone receives an active treatment
How many people
2,000 participants
Where
1 siteChad
Study dates
Jun 2010to Feb 2011
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 6 to 36 months
  • All sexes
  • Healthy volunteers accepted
  • Child

Who may be able to join

  • WH≥80% of median of NCHS reference without bilateral pitting oedema;
  • Age ≥ 6 months and ≤36 months;
  • Member of a household with a dependency ratio >4;
  • Not planning to leave the study zone for the coming 5 months;

Who cannot join

  • Not showing appetite;
  • Age < 6 months or age > 36 months
  • Weight-for-Height Z-score <-2 and/or the presence of bilateral pitting oedema in children 6-36 months;
  • Member of a household with a dependency ration ≤ 4;
  • Clinical complications
  • Presence of chronic illness, cardiac disease, congenital abnormalities, cancer;
  • Being allergic to one of the ingredients of the RUF.

Trial locations and contacts

1 site in 1 country.

Chad1 site

  • Action Contre La Faim Tchad

    Abéché

About this study

Official title: Effectiveness and Cost-effectiveness of a Ready-to-Use-Food (RUF) Supplement to Prevent Acute Malnutrition in Children Between 6-36 Months in Urban Chad

The overall objective of this project is to assess the effectiveness and cost-effectiveness of RUF (ready-to-Use Food, Plumpy Doz(r)) to prevent moderate acute malnutrition in children aged 6-36 months if embedded in a program of conditional household food assistance.

Conditions
Child, Malnutrition
Being tested
Plumpy Doz(r) - Ready-to-Use Food, Food-for-Training
Keywords
moderate acute malnutrition, prevention, Lipid-based supplement
Medical subject headings
Malnutrition

What participants receive

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

  • Plumpy Doz(r) - Ready-to-Use FoodDietary supplement

    47g Plumpy Doz(r) per day per child

  • Food-for-TrainingBehavioural

    Conditional family food supplementation (sugar, sorghum, beans, iodized salt, vegetable oil) 1800 kcal/person/day in function of attendance and participation in a sensitization program covering various themes on household, water and disease management, hygiene promotion, sanitation and dietary practices for children.

Study groups in NCT01154595
Study groupRoleWhat they receive
Food-for-Training componentActive comparatorConditional family food supplementation (sugar, sorghum, beans, iodized salt, vegetable oil) 1800 kcal/person/day in function of attendance and participation in a sensitization program covering various themes on household, water and disease management, hygiene promotion, sanitation and dietary practices for children.
Receives: Behavioral: Food-for-Training
Food-for-Training + RUF (Plumpy Doz(r))ExperimentalConditional family food supplementation (sugar, sorghum, beans, iodized salt, vegetable oil) 1800 kcal/person/day in function of attendance and participation in a sensitization program covering various themes on household, water and disease management, hygiene promotion, sanitation and dietary practices for children. In addition, a blanket supplementation with 47g RUF (Plumpy Doz(r)) per day per child is provided.
Receives: Dietary Supplement: Plumpy Doz(r) - Ready-to-Use Food; Behavioral: Food-for-Training

What is being measured

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

  1. Cumulative wasting incidence, hemoglobin concentration

    Measured: monthly

Secondary outcomes (5)

  1. weight gain

    Measured: monthly

  2. time to become wasted

    Measured: monthly

  3. default rate

    Measured: monthly

  4. RUF acceptability

    Measured: monthly

  5. dietary intake

    Measured: monthly

Timeline

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

  1. First posted1 Jul 2010 (estimated)
  2. Study startJun 2010
  3. Primary completionFeb 2011
  4. Study completionFeb 2011

Resources

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
Single blind
Who is masked
Outcomes assessor
Enrolment
2,000 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01154595
Sponsor's protocol ID
UGENT0410
Acronym
PREAMA
Status last verified
Oct 2011
First submitted
29 Jun 2010
Last updated
12 Oct 2011
Results posted
No
Data monitoring committee
Yes

Publications

  • Huybregts L, Houngbe F, Salpeteur C, Brown R, Roberfroid D, Ait-Aissa M, Kolsteren P. The effect of adding ready-to-use supplementary food to a general food distribution on child nutritional status and morbidity: a cluster-randomized controlled trial. PLoS Med. 2012;9(9):e1001313. doi: 10.1371/journal.pmed.1001313. Epub 2012 Sep 18.

    PubMed 23028263

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Plumpy Doz(r) - Ready-to-Use Food and Food-for-Training in people with Child and Malnutrition, run by Action Contre la Faim at 1 site in Chad.

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 4 inclusion and 7 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 12 Oct 2011. 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 Chad. 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.

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?

Cumulative wasting incidence, hemoglobin concentration (time frame: monthly). 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 NCT01154595, 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 12 Oct 2011.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in