Moderately Malnourished ChildrenPhase 2/3NCT01553877
Development and Acceptability Testing of Ready-to-use-complementary Food Supplement (RUCFS) for Children in Bangladesh
A Phase 2/3 study testing Pushti packet, Rice based Ready to Use Complementary Food Supplements and Chick-pea based Ready to Use Complementary Food Supplements in people with Moderately Malnourished Children, run by International Centre for Diarrhoeal Disease Research, Bangladesh at 1 site in Bangladesh.
Trial summary
The prevention of malnutrition among children under 5 years of age requires consumption of nutritious food, including exclusive breast feeding for the first six months of life, followed by breastfeeding in combination with complementary foods thereafter until at least 24 months of age; a hygienic environment; access… Read more about this study
- Who is it for?
- Ages 6 to 18 monthsHealthy volunteers can take part
- Conditions the study is for
- Moderately Malnourished Children
- What is being tested?
- Pushti packet, Rice based Ready to Use Complementary Food Supplements and Chick-pea based Ready to Use Complementary Food Supplements
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteBangladesh
- Study dates
- Jan 2012to May 2012
- Phase
- Phase 2/3
- 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 18 months
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 6 to 18 months; either sex, having no acute illness, and be on at least one semi-solid or solid food in a day.
Who cannot join
- loss of appetite,
- oral lesion,
- congenital anomaly/acquired disorder affecting growth,
- severe acute malnutrition (SAM) defined by:
- MUAC < 115 mm or
- WL < -3 Z score or
Show all 10Show fewer
- bipedal edema,
- persistent diarrhea,
- tuberculosis,
- any other chronic illness.
Trial locations and contacts
1 site in 1 country.
About this study
The prevention of malnutrition among children under 5 years of age requires consumption of nutritious food, including exclusive breast feeding for the first six months of life, followed by breastfeeding in combination with complementary foods thereafter until at least 24 months of age; a hygienic environment; access to preventive as well as curative health services, and good prenatal care. The proposed research is on the possible options for providing a nutritious diet, realizing the constraints of poverty and food insecurity faced by care givers whose children are at risk of developing or confirmed to be suffering from moderate malnutrition. Even when people are not typically food insecure but consume a relatively monotonous diet with few good-quality foods, they also have to have options for dietary improvement, and especially the possibility of ready-to-use complementary food supplements (RUCFS) for young children. This proposed research on development of RUCFS will pave the way for programmatic considerations for expansion of the use of new complementary food supplements for preventing malnutrition among young children in Bangladesh.
- Conditions
- Moderately Malnourished Children
- Being tested
- Pushti packet, Rice based Ready to Use Complementary Food Supplements, Chick-pea based Ready to Use Complementary Food Supplements
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pushti packetDietary supplement
Also called A food composed of roasted rice, roasted lentil, molasses and soybean oil
A food composed of roasted rice, roasted lentil, molasses and soybean oil
Rice based Ready to Use Complementary Food SupplementsDietary supplement
A rice based diet.
Chick-pea based Ready to Use Complementary Food SupplementsDietary supplement
A chick-pea based diet.
| Study group | Role | What they receive |
|---|---|---|
| Pushti Packet | Active comparator | Not described Receives: Dietary Supplement: Pushti packet |
| Rice based Ready to Use Complementary Food Supplements | Experimental | Not described Receives: Dietary Supplement: Rice based Ready to Use Complementary Food Supplements |
| Chick-pea based Ready to Use Complementary Food Supplements | Active comparator | Not described Receives: Dietary Supplement: Chick-pea based Ready to Use Complementary Food Supplements |
What is being measured
The primary outcome is the main question the study is designed to answer.
Acceptability of at least one Ready -to-Use Complementary Food supplement
At least one of the experimental Ready -to-Use Complementary Food supplement will be acceptable to the study participants for prevention of malnutrition. The acceptability will be assessed by a 7-point Hedonic scale.
Measured: 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Mar 2012 (estimated)
- Study startJan 2012
- Primary completionFeb 2012
- Study completionMay 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Moderately Malnourished ChildrenStudies 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 2/3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Care provider
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- International Centre for Diarrhoeal Disease Research, Bangladesh
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01553877
- Sponsor's protocol ID
- PR-10066
- Status last verified
- Mar 2012
- First submitted
- 24 Jan 2012
- Last updated
- 3 Jan 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
Ahmed T, Choudhury N, Hossain MI, Tangsuphoom N, Islam MM, de Pee S, Steiger G, Fuli R, Sarker SA, Parveen M, West KP Jr, Christian P. Development and acceptability testing of ready-to-use supplementary food made from locally available food ingredients in Bangladesh. BMC Pediatr. 2014 Jun 27;14:164. doi: 10.1186/1471-2431-14-164.
PubMed 24972632
Study at a glance
From the registry record, last updated by the sponsor on 3 Jan 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development and Acceptability Testing of Ready-to-use-complementary Food Supplement (RUCFS) for Children in Bangladesh
- ClinicalTrials.gov ID
- NCT01553877
- Acronym / sponsor ID
- PR-10066
- Conditions
- Moderately Malnourished Children
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- International Centre for Diarrhoeal Disease Research, BangladeshUniversity, hospital or other
- Study start
- Jan 2012
- Primary completion
- Feb 2012 (actual)
- Study completion
- May 2012 (actual)
- First posted
- 14 Mar 2012 (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.
The prevention of malnutrition among children under 5 years of age requires consumption of nutritious food, including exclusive breast feeding for the first six months of life, followed by breastfeeding in combination with complementary foods thereafter until at least 24 months of age; a hygienic environment; access to preventive as well as curative health services, and good prenatal care. The proposed research is on the possible options for providing a nutritious diet, realizing the constraints of poverty and food insecurity faced by care givers whose children are at risk of developing or confirmed to be suffering from moderate malnutrition. Even when people are not typically food insecure but consume a relatively monotonous diet with few good-quality foods, they also have to have options for dietary improvement, and especially the possibility of ready-to-use complementary food supplements (RUCFS) for young children. This proposed research on development of RUCFS will pave the way for programmatic considerations for expansion of the use of new complementary food supplements for preventing malnutrition among young children in Bangladesh.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (care provider)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Pushti Packet | Active comparator | Dietary Supplement: Pushti packet |
| Rice based Ready to Use Complementary Food Supplements | Experimental | Dietary Supplement: Rice based Ready to Use Complementary Food Supplements |
| Chick-pea based Ready to Use Complementary Food Supplements | Active comparator | Dietary Supplement: Chick-pea based Ready to Use Complementary Food Supplements |
Who may qualify
- Ages
- 6 to 18 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- 6 to 18 months; either sex, having no acute illness, and be on at least one semi-solid or solid food in a day.
Key exclusion criteria (10 listed)
- loss of appetite,
- oral lesion,
- congenital anomaly/acquired disorder affecting growth,
- severe acute malnutrition (SAM) defined by:
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 |
|---|---|---|
| Pushti packetAlso: A food composed of roasted rice, roasted lentil, molasses and soybean oilA food composed of roasted rice, roasted lentil, molasses and soybean oil | Dietary supplement | Pushti Packet |
| Rice based Ready to Use Complementary Food SupplementsA rice based diet. | Dietary supplement | Rice based Ready to Use Complementary Food Supplements |
| Chick-pea based Ready to Use Complementary Food SupplementsA chick-pea based diet. | Dietary supplement | Chick-pea based Ready to Use Complementary Food Supplements |
Primary outcome
Acceptability of at least one Ready -to-Use Complementary Food supplement
Time frame: 7 days
At least one of the experimental Ready -to-Use Complementary Food supplement will be acceptable to the study participants for prevention of malnutrition. The acceptability will be assessed by a 7-point Hedonic scale.
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 3 Jan 2013.
- Derived from this study: PubMed 24972632Ahmed T, Choudhury N, Hossain MI, Tangsuphoom N, Islam MM, de Pee S, Steiger G, Fuli R, Sarker SA, Parveen M, West KP Jr, Christian P. Development and acceptability testing of ready-to-use supplementary food made from locally available food ingredients in Bangladesh. BMC Pediatr. 2014 Jun 27;14:164. doi: 10.1186/1471-2431-14-164.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Pushti packet, Rice based Ready to Use Complementary Food Supplements and Chick-pea based Ready to Use Complementary Food Supplements in people with Moderately Malnourished Children, run by International Centre for Diarrhoeal Disease Research, Bangladesh at 1 site in Bangladesh.
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 10 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 3 Jan 2013. 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 Bangladesh. 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 combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Acceptability of at least one Ready -to-Use Complementary Food supplement (time frame: 7 days). 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 NCT01553877, 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 3 Jan 2013.