MalnutritionPhase 3NCT00420758
Effectiveness Trial on Alleviation of Infant Malnutrition With Fortified Spread or Maize-Soy Flour Food Supplements
A Phase 3 study testing Food supplement: fortified spread and Food supplement: maize-soy flour in people with Malnutrition, run by Tampere University at 1 site in Malawi.
Trial summary
This study tests the hypothesis that moderately underweight but not severely wasted 6-17-month old infants receiving fortified spread or maize-spy flour as a food supplement for 12 weeks grow better during the supplementation than infants who do not get any food 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-soy flour
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 299 participants
- Where
- 1 siteMalawi
- Study dates
- Nov 2007to May 2008
- 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
- age 6.00 months to 14.99 months
- weight-for-age <-2.0 Z scores
- availability during the period of the study
- permanent resident Lungwena Health Centre catchment area
Who cannot join
- moderate or severe wasting (WHM<80% of the reference median)
- history of peanut allergy
- history of any serious allergic reaction to any substance, requiring emergency medical care
- history of anaphylaxis
- 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: LCNI-7. A Three-centre Intervention Trial in Rural Malawi, Testing the Effectiveness of Fortified Spread or Maize-Soy Flour Supplementation to Alleviate Moderate Malnutrition Among 6-18 Month Old Children
This study tests the hypothesis that moderately underweight but not severely wasted 6-17-month old infants receiving fortified spread or maize-spy flour as a food supplement for 12 weeks grow better during the supplementation than infants who do not get any food 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 micronutrient fortified spread, FS, 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, but not wasted, infants (defined as WAZ <-2, WHM=>80%) between 6 and 18 months of age.
The study will be conducted in Lungwena area, Mangochi District, rural Malawi. A total of 291 6-15 -month old infants will be enrolled and randomised to three groups receiving different daily food supplements for 12 weeks. Children in group one (control group) will not receive any supplementation, children in group two will receive 1200 g FS 4-weekly (43 g / day) and children in group 3 will received 2000 g of fortified maize/soy flour weekly (71 g / day). Participant´s guardians will collect the food supplements from a local health centre at 4-weekly intervals.
All children will undergo medical and anthropometric examinations at the beginning and end of the 12-week follow-up period. Dietary intake assessments will be conducted at 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 concentration.
The impact of the dietary interventions will be primarily assessed by comparing weight gain in the three intervention groups. Secondary outcomes include length gain and changes in blood haemoglobin concentration. The study will also produce descriptive data on intake of foods during the intervention.
- Conditions
- Malnutrition
- Being tested
- Food supplement: fortified spread, Food supplement: maize-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 spreadDietary supplement
Provision of fortified spread
Food supplement: maize-soy flourDietary supplement
Provision of corn-soy blend (maize-soy flour)
| Study group | Role | What they receive |
|---|---|---|
| Control | No intervention | Not described |
| LNS | Experimental | Lipid-based nutrient supplement Receives: Dietary Supplement: Food supplement: fortified spread |
| CSB | Experimental | Corn-soy blend supplement Receives: Dietary Supplement: Food supplement: maize-soy flour |
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)
Measured: 12 weeks
Secondary outcomes (5)
Length gain during the 12-week follow-up (in centimetres
Measured: 12 weeks
Change in blood haemoglobin concentration during the study period (g/l)
Measured: 12 weeks
Change in anthropometric indices (WAZ, WHZ and HAZ)
Measured: 12 weeks
Proportion developing moderate or severe wasting during the intervention (WHM<80% of the reference mean)
Measured: 12 weeks
Change in mid-upper arm and head circumference
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jan 2007 (estimated)
- Study startNov 2007
- Primary completionMay 2008
- Study completionMay 2008
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
- Who is masked
- Outcomes assessor
- Enrolment
- 299 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tampere University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Per Ashorn, Tampere University
- Investigators
- Per Ashorn, MD, PhD, Study director, University of Tampere, Medical School, FinlandKenneth Maleta, MBBS, PhD, Principal investigator, University of Malawi, College of Medicine, Department of Community Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00420758
- Sponsor's protocol ID
- AF-109796-b
- Status last verified
- Dec 2015
- First submitted
- 10 Jan 2007
- Last updated
- 4 Dec 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 4 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- LCNI-7. A Three-centre Intervention Trial in Rural Malawi, Testing the Effectiveness of Fortified Spread or Maize-Soy Flour Supplementation to Alleviate Moderate Malnutrition Among 6-18 Month Old Children
- ClinicalTrials.gov ID
- NCT00420758
- Acronym / sponsor ID
- AF-109796-b
- 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
- 299 participants (actual)
- Lead sponsor
- Tampere UniversityUniversity, hospital or other
- Study start
- Nov 2007
- Primary completion
- May 2008 (actual)
- Study completion
- May 2008 (actual)
- First posted
- 11 Jan 2007 (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 moderately underweight but not severely wasted 6-17-month old infants receiving fortified spread or maize-spy flour as a food supplement for 12 weeks grow better during the supplementation than infants who do not get any food 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 micronutrient fortified spread, FS, 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, but not wasted, infants (defined as WAZ <-2, WHM=>80%) between 6 and 18 months of age.
The study will be conducted in Lungwena area, Mangochi District, rural Malawi. A total of 291 6-15 -month old infants will be enrolled and randomised to three groups receiving different daily food supplements for 12 weeks. Children in group one (control group) will not receive any supplementation, children in group two will receive 1200 g FS 4-weekly (43 g / day) and children in group 3 will received 2000 g of fortified maize/soy flour weekly (71 g / day). Participant´s guardians will collect the food supplements from a local health centre at 4-weekly intervals.
All children will undergo medical and anthropometric examinations at the beginning and end of the 12-week follow-up period. Dietary intake assessments will be conducted at 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 concentration.
The impact of the dietary interventions will be primarily assessed by comparing weight gain in the three intervention groups. Secondary outcomes include length gain and changes in blood haemoglobin concentration. The study will also produce descriptive data on intake of foods during the intervention.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | – |
| LNS | Experimental | Dietary Supplement: Food supplement: fortified spreadLipid-based nutrient supplement |
| CSB | Experimental | Dietary Supplement: Food supplement: maize-soy flourCorn-soy blend supplement |
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
- age 6.00 months to 14.99 months
- weight-for-age <-2.0 Z scores
- availability during the period of the study
- permanent resident Lungwena Health Centre catchment area
Key exclusion criteria (6 listed)
- moderate or severe wasting (WHM<80% of the reference median)
- history of peanut allergy
- history of any serious allergic reaction to any substance, requiring emergency medical care
- history of anaphylaxis
- severe illness warranting hospital referral
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 spreadProvision of fortified spread | Dietary supplement | LNS |
| Food supplement: maize-soy flourProvision of corn-soy blend (maize-soy flour) | Dietary supplement | CSB |
Primary outcome
Weight gain during the 12-week follow-up (in grams)
Time frame: 12 weeks
5 secondary outcomes
Length gain during the 12-week follow-up (in centimetres
Time frame: 12 weeks
Change in blood haemoglobin concentration during the study period (g/l)
Time frame: 12 weeks
Change in anthropometric indices (WAZ, WHZ and HAZ)
Time frame: 12 weeks
Proportion developing moderate or severe wasting during the intervention (WHM<80% of the reference mean)
Time frame: 12 weeks
Change in mid-upper arm and head circumference
Time frame: 12 weeks
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 4 Dec 2015.
- 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, Finland
Kenneth Maleta, MBBS, PhD principal investigator
University of Malawi, College of Medicine, Department of Community Health
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-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 6 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 4 Dec 2015. 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) (time frame: 12 weeks). 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 4 Dec 2015.