MalnutritionPhase 3NCT00131222
Trial to Alleviate Malnutrition With Fortified Spread Given as a Food Supplement to Underweight Infants
A Phase 3 study testing Food supplement: fortified spread and Food supplement: maize and soy flour in people with Malnutrition, run by Tampere University at 1 site in Malawi.
Trial summary
This study tests the hypothesis that underweight 6-17-month old infants receiving fortified spread as a food supplement for 12 weeks grow better during the supplementation than infants who are provided with maize-soy flour supplement. Read more about this study
- Who is it for?
- Ages 6 to 15 months
- Conditions the study is for
- Malnutrition
- What is being tested?
- Food supplement: fortified spread and Food supplement: maize and soy flour
- Type of treatment
- Surgery or procedure
- How many people
- 176 participants
- Where
- 1 siteMalawi
- Study dates
- Feb 2005to Sep 2005
- Phase
- Phase 3
- 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 15 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Signed informed consent from at least one guardian
- Ages 6.00 months to 14.99 months
- Weight-for-age < -2 z-scores
- Availability during the period of the study
- Permanent resident of the area
Who cannot join
- WHZ < -3 z-scores or presence of oedema
- History of peanut allergy
- Severe illness warranting hospital referral
- Concurrent participation in another clinical trial with intervention to the child
Trial locations and contacts
1 site in 1 country.
Malawi1 site
College of Medicine, University of Malawi
Mangochi, Mangochi District
About this study
Official title: Lungwena Child Nutrition Intervention Study-4, LCNI-4. A Single-centre Intervention Trial in Rural Malawi, Testing the Potency of RUTF Supplementation to Alleviate Moderate Malnutrition Among 6-17 Month Old Infants
This study tests the hypothesis that underweight 6-17-month old infants receiving fortified spread as a food supplement for 12 weeks grow better during the supplementation than infants who are provided with maize-soy flour supplement.
Read the detailed description
Childhood undernutrition is very common in rural Malawi, like in many other countries in Sub-Saharan Africa. Usually, undernutrition develops between 6 and 24 months of age. By two years of age, 30-50% of all children in rural Malawi are undernourished, predisposing them to subsequent morbidity, developmental delay and mortality. Urgent interventions are needed but the magnitude of the problem precludes a hospital-based management strategy. Therefore, emphasis must be on prevention and early home-based rehabilitation of children with mild-to-moderate malnutrition. However, the options for community based approaches are not as developed as those for institutional management of undernutrition.
The present study tests a recently developed nutrient -dense spread, ready-to use- therapeutic food (RUTF), which offers a potential solution to home based nutrition rehabilitation. The concept has previously been shown to work not only in therapeutic feeding of undernourished children in nutrition rehabilitation units in Malawi but also home based supplementation of undernourished children aged 42 to 60 months in Mangochi District, southern Malawi. In the present study the investigators will test the efficacy in growth promotion of this product when provided as a supplementary food to moderately underweight infants (defined as WAZ <-2) between 6 and 18 months of age.
The study will be conducted in Lungwena area, Mangochi District, rural Malawi. A total of 176 6-14 -month old infants will be enrolled and randomised to two groups receiving different daily food supplements for 12 weeks. Children in group one (control group) will receive 72g of fortified maize/soy flour and children in group 2 will receive 50g RUTF daily. The food supplements will be delivered to the participant's home at 3-weekly intervals.
All children will undergo medical and anthropometric examinations at 6-weekly intervals and disease symptoms monitoring every week. Dietary intake assessments will be conducted at 3 and 9 weeks after the onset of supplementation. A blood sample will be collected at the beginning and end of the study to measure blood haemoglobin and serum ferritin concentrations. At enrolment, children's HIV status will be screened with antibody-ELISA and confirmed with HIV PCR.
The impact of the dietary interventions will be primarily assessed by comparing weight gain in the two intervention groups. Secondary outcomes include length gain, increase in tibial length and changes in blood haemoglobin and serum ferritin concentration. The study will also produce descriptive data on morbidity and intake of foods during the intervention.
- Conditions
- Malnutrition
- Being tested
- Food supplement: fortified spread, Food supplement: maize and soy flour
- Keywords
- Infant, Malnutrition, Sub-Saharan Africa, Treatment, Growth, Haemoglobin, Fortified spread, Food supplement
- Medical subject headings
- Malnutrition
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Food supplement: fortified spreadProcedure or surgery
Food supplement: maize and soy flourProcedure or surgery
What is being measured
The primary outcome is the main question the study is designed to answer.
Weight gain during the 12-week follow-up (in grams)
Secondary outcomes (5)
Length gain during the study period (mm)
Tibial length gain during the study period (mm)
Change in blood haemoglobin concentration during the study period (g/l)
Change in serum ferritin concentration during the study period (µg/l)
Mean change in anthropometric indices (weight-for-age z-score [WAZ], weight-for-height z-score [WHZ] and height-for-age z-score [HAZ])
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Aug 2005 (estimated)
- Study startFeb 2005
- Study completionSep 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MalnutritionStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Enrolment
- 176 participants
Sponsor and investigators
- Lead sponsor
- Tampere University
- Sponsor type
- University, hospital or other
- Collaborators
- Academy of Finland, Foundation for Paediatric Research, Finland
- Investigators
- Per Ashorn, MD, PhD, Study director, University of Tampere, Medical SchoolKenneth M Maleta, MBBS, PhD, Principal investigator, Kamuzu University of Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00131222
- Sponsor's protocol ID
- SA-1200720-4
- Status last verified
- Apr 2007
- First submitted
- 16 Aug 2005
- Last updated
- 20 May 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 20 May 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Lungwena Child Nutrition Intervention Study-4, LCNI-4. A Single-centre Intervention Trial in Rural Malawi, Testing the Potency of RUTF Supplementation to Alleviate Moderate Malnutrition Among 6-17 Month Old Infants
- ClinicalTrials.gov ID
- NCT00131222
- Acronym / sponsor ID
- SA-1200720-4
- Conditions
- Malnutrition
- Keywords
- Infant, Malnutrition, Sub-Saharan Africa, Treatment, Growth, Haemoglobin, Fortified spread, Food supplement
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 176 participants
- Lead sponsor
- Tampere UniversityUniversity, hospital or other
- Collaborators
- Academy of Finland, Foundation for Paediatric Research, Finland
- Study start
- Feb 2005
- Study completion
- Sep 2005 (actual)
- First posted
- 17 Aug 2005 (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.
This study tests the hypothesis that underweight 6-17-month old infants receiving fortified spread as a food supplement for 12 weeks grow better during the supplementation than infants who are provided with maize-soy flour supplement.
Detailed description
Childhood undernutrition is very common in rural Malawi, like in many other countries in Sub-Saharan Africa. Usually, undernutrition develops between 6 and 24 months of age. By two years of age, 30-50% of all children in rural Malawi are undernourished, predisposing them to subsequent morbidity, developmental delay and mortality. Urgent interventions are needed but the magnitude of the problem precludes a hospital-based management strategy. Therefore, emphasis must be on prevention and early home-based rehabilitation of children with mild-to-moderate malnutrition. However, the options for community based approaches are not as developed as those for institutional management of undernutrition.
The present study tests a recently developed nutrient -dense spread, ready-to use- therapeutic food (RUTF), which offers a potential solution to home based nutrition rehabilitation. The concept has previously been shown to work not only in therapeutic feeding of undernourished children in nutrition rehabilitation units in Malawi but also home based supplementation of undernourished children aged 42 to 60 months in Mangochi District, southern Malawi. In the present study the investigators will test the efficacy in growth promotion of this product when provided as a supplementary food to moderately underweight infants (defined as WAZ <-2) between 6 and 18 months of age.
The study will be conducted in Lungwena area, Mangochi District, rural Malawi. A total of 176 6-14 -month old infants will be enrolled and randomised to two groups receiving different daily food supplements for 12 weeks. Children in group one (control group) will receive 72g of fortified maize/soy flour and children in group 2 will receive 50g RUTF daily. The food supplements will be delivered to the participant's home at 3-weekly intervals.
All children will undergo medical and anthropometric examinations at 6-weekly intervals and disease symptoms monitoring every week. Dietary intake assessments will be conducted at 3 and 9 weeks after the onset of supplementation. A blood sample will be collected at the beginning and end of the study to measure blood haemoglobin and serum ferritin concentrations. At enrolment, children's HIV status will be screened with antibody-ELISA and confirmed with HIV PCR.
The impact of the dietary interventions will be primarily assessed by comparing weight gain in the two intervention groups. Secondary outcomes include length gain, increase in tibial length and changes in blood haemoglobin and serum ferritin concentration. The study will also produce descriptive data on morbidity and intake of foods during the intervention.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
Who may qualify
- Ages
- 6 to 15 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- Signed informed consent from at least one guardian
- Ages 6.00 months to 14.99 months
- Weight-for-age < -2 z-scores
- Availability during the period of the study
- Permanent resident of the area
Key exclusion criteria (4 listed)
- WHZ < -3 z-scores or presence of oedema
- History of peanut allergy
- Severe illness warranting hospital referral
- Concurrent participation in another clinical trial with intervention to the 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 |
|---|---|---|
| Food supplement: fortified spread | Procedure or surgery | – |
| Food supplement: maize and soy flour | Procedure or surgery | – |
Primary outcome
Weight gain during the 12-week follow-up (in grams)
5 secondary outcomes
Length gain during the study period (mm)
Tibial length gain during the study period (mm)
Change in blood haemoglobin concentration during the study period (g/l)
Change in serum ferritin concentration during the study period (µg/l)
Mean change in anthropometric indices (weight-for-age z-score [WAZ], weight-for-height z-score [WHZ] and height-for-age z-score [HAZ])
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 20 May 2014.
- College of Medicine home pageLink provided by the sponsor.
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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.
Per Ashorn, MD, PhD study director
University of Tampere, Medical School
Kenneth M Maleta, MBBS, PhD principal investigator
Kamuzu University of Health Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Food supplement: fortified spread and Food supplement: maize and soy flour in people with Malnutrition, run by Tampere University at 1 site 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 5 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 20 May 2014. 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 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
Weight gain during the 12-week follow-up (in grams). 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 20 May 2014.