MalnutritionNCT01129089
Acceptability of Nutrient Supplements Among Women and Children in Bangladesh
A study testing Lipid-based nutrient supplement and Micronutrient powder in people with Malnutrition, run by University of California, Davis at 1 site in Bangladesh.
Trial summary
The study aims to confirm the acceptability of lipid-based nutrient supplements (LNS) for use as nutritional supplements for pregnant and lactating women (PLW) or infants and young children (IYC) and micronutrient powder (MNP) for use as nutritional supplements for infants and young children in Bangladesh.We… Read more about this study
- Who is it for?
- Ages 6 months to 49 years
- Conditions the study is for
- Malnutrition
- What is being tested?
- Lipid-based nutrient supplement and Micronutrient powder
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 144 participants
- Where
- 1 siteBangladesh
- Study dates
- Dec 2009to Feb 2010
- Phase
- Interventional
- 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 months to 49 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Pregnant women in their second or third trimester (in case of third trimester pregnancy, the expected date of delivery is not within three weeks) or lactating women with a child between 3 days and 6 months of age
- At least 18 years of age
- No life-threatening pregnancy-related complications (e.g., pre-eclampsia, antepartum hemorrhage)
- Apparently healthy and not presently suffering from an acute illness (e.g., fever, diarrhea, acute respiratory tract infection)
- Living in the study area for at least 6 months
- Planning to remain in study area for at least the following three weeks.
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- Children 6-24 months of age
- Consuming solid foods for at least the past 30 days
- Apparently healthy and not presently suffering from an acute illness (e.g., fever, diarrhea, acute respiratory tract infection)
- No known allergy to peanuts or other food products (as reported on the screening questionnaire by the mother/primary caregiver)[LNS-Child only]
- Planning to remain in study area for at least the following three weeks.
Who cannot join
- Known allergy to peanuts or other food products (as reported on the screening questionnaire)
- Severely malnourished [mid-upper arm circumference (MUAC) < 115 mm]
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Acceptability of Lipid-based Nutrient Supplements (LNS) and Micronutrient Powder (MNP) for Women and Infants in Bangladesh
The study aims to confirm the acceptability of lipid-based nutrient supplements (LNS) for use as nutritional supplements for pregnant and lactating women (PLW) or infants and young children (IYC) and micronutrient powder (MNP) for use as nutritional supplements for infants and young children in Bangladesh.We hypothesized that at least 75 percent of the test dose of LNS and MNP offered to PLW and IYC will be consumed by them.
Read the detailed description
The study will be conducted in three steps. Step 1 will be a test-feeding to compare the acceptability of each "version" of the LNS-child (LNS-child with cardamom flavor, LNS-child with no added flavor),LNS-PLW (LNS-PLW with cumin flavor, and LNS-PLW with no added flavor) and MNP to the others in terms of taste, smell and texture, as well as amount of the test-dose consumed. In Step 2, participants in the Phase 1 trial will receive a 2-week supply of one of the LNS products or MNP, which they will consume daily in their homes for 14 days under real-life conditions. In Step 3, focus group discussions will be held with participants to discuss different aspects of infant and child feeding and discuss best ways for the LNS or MNP product to be used in the context of Bangladesh.
- Conditions
- Malnutrition
- Being tested
- Lipid-based nutrient supplement, Micronutrient powder
- Keywords
- Acceptability, Lipid-based nutrient supplements, Micronutrient powder, Malnutrition
- Medical subject headings
- Malnutrition
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lipid-based nutrient supplementDietary supplement
Also called LNS
Lipid-based nutrient supplement for pregnant and lactating women
Lipid-based nutrient supplementDietary supplement
Also called LNS
Lipid-based nutrient supplement for infant and young children
Micronutrient powderDietary supplement
Also called MNP, Sprinkles
Micronutrient powder for infant and young children
| Study group | Role | What they receive |
|---|---|---|
| LNS-PLW | Experimental | There will be 48 pregnant or lactating women (PLW) in this arm. They will be randomized to receive cumin flavored LNS-PLW or LNS-PLW with no added flavor on day 2. On day 3, the PLW getting a test-dose of cumin flavored LNS-PLW on day 2 will receive LNS-PLW with no added flavor and the PLW getting a test-dose of LNS-PLW with no added flavor on day 2 will receive cumin flavored LNS-PLW. Receives: Dietary Supplement: Lipid-based nutrient supplement |
| LNS-Child | Experimental | There will be 48 infant and young children(IYC) in this arm. They will be randomized to receive cardamom flavored LNS-Child or LNS-Child with no added flavor on day 2. On day 3, the IYC getting a test-dose of LNS-Child with no added flavor on day 2 will receive cardamom flavored LNS-Child and the IYC getting a test-dose of cardamom flavored LNS-Child on day 2 will receive LNS-Child with no added flavor. Receives: Dietary Supplement: Lipid-based nutrient supplement |
| MNP-Child | Experimental | There will be 48 infant and young children(IYC) in this arm. They will receive MNP on day 2 and day 3. Receives: Dietary Supplement: Micronutrient powder |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of test dose consumed
Mean consumption of the test dose of LNS for PLW, LNS for IYC and MNP for IYC on day 2 (First test dose)
Measured: Day 2
Proportion of test dose consumed
Mean consumption of the test dose of LNS for PLW, LNS for IYC and MNP for IYC on day 3(Second test dose)
Measured: Day 3
Secondary outcomes (4)
Proportion of subjects liked the supplements
Using a five point Likert scale proportion of PLW and IYC liked the supplements will be acertained.
Measured: Day 2
Proportion of subjects liked the supplement
Using a five point Likert scale proportion of PLW and IYC liked the supplements will be acertained.
Measured: Day 3
Proportion of subjects liked the supplement
Using a five point Likert scale proportion of PLW and IYC liked the supplements will be acertained.
Measured: Day 8
Proportion of subjects liked the supplement
Using a five point Likert scale proportion of PLW and IYC liked the supplements will be acertained.
Measured: Day 15
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 May 2010 (estimated)
- Study startDec 2009
- Primary completionJan 2010
- Study completionFeb 2010
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.
- More trials run by University of California, DavisThe sponsor's other registered studies.
- 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
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 144 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, Davis
- Sponsor type
- University, hospital or other
- Collaborators
- United States Agency for International Development (USAID)
- Responsible party
- Sponsor
- Investigators
- Katnryn G Dewey, Ph.D., Principal investigator, University of California, DavisMalay K Mridha, MBBS,MPH, Study director, University of Callifornia, DavisCamila M Chaparro, Ph.D., Study director, Academy for Educational Development
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01129089
- Sponsor's protocol ID
- 273918
- Other IDs
- 4001-UCD-00
- Status last verified
- Sep 2024
- First submitted
- 13 May 2010
- Last updated
- 23 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Acceptability of Lipid-based Nutrient Supplements (LNS) and Micronutrient Powder (MNP) for Women and Infants in Bangladesh
- ClinicalTrials.gov ID
- NCT01129089
- Acronym / sponsor ID
- 273918
- Conditions
- Malnutrition
- Keywords
- Acceptability, Lipid-based nutrient supplements, Micronutrient powder, Malnutrition
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 144 participants (actual)
- Lead sponsor
- University of California, DavisUniversity, hospital or other
- Collaborators
- United States Agency for International Development (USAID)
- Study start
- Dec 2009
- Primary completion
- Jan 2010 (actual)
- Study completion
- Feb 2010 (actual)
- First posted
- 24 May 2010 (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 study aims to confirm the acceptability of lipid-based nutrient supplements (LNS) for use as nutritional supplements for pregnant and lactating women (PLW) or infants and young children (IYC) and micronutrient powder (MNP) for use as nutritional supplements for infants and young children in Bangladesh.We hypothesized that at least 75 percent of the test dose of LNS and MNP offered to PLW and IYC will be consumed by them.
Detailed description
The study will be conducted in three steps. Step 1 will be a test-feeding to compare the acceptability of each "version" of the LNS-child (LNS-child with cardamom flavor, LNS-child with no added flavor),LNS-PLW (LNS-PLW with cumin flavor, and LNS-PLW with no added flavor) and MNP to the others in terms of taste, smell and texture, as well as amount of the test-dose consumed. In Step 2, participants in the Phase 1 trial will receive a 2-week supply of one of the LNS products or MNP, which they will consume daily in their homes for 14 days under real-life conditions. In Step 3, focus group discussions will be held with participants to discuss different aspects of infant and child feeding and discuss best ways for the LNS or MNP product to be used in the context of Bangladesh.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| LNS-PLW | Experimental | Dietary Supplement: Lipid-based nutrient supplementThere will be 48 pregnant or lactating women (PLW) in this arm. They will be randomized to receive cumin flavored LNS-PLW or LNS-PLW with no added flavor on day 2. On day 3, the PLW getting a test-dose of cumin flavored LNS-PLW on day 2 will receive LNS-PLW with no added flavor and the PLW getting a test-dose of LNS-PLW with no added flavor on day 2 will receive cumin flavored LNS-PLW. |
| LNS-Child | Experimental | Dietary Supplement: Lipid-based nutrient supplementThere will be 48 infant and young children(IYC) in this arm. They will be randomized to receive cardamom flavored LNS-Child or LNS-Child with no added flavor on day 2. On day 3, the IYC getting a test-dose of LNS-Child with no added flavor on day 2 will receive cardamom flavored LNS-Child and the IYC getting a test-dose of cardamom flavored LNS-Child on day 2 will receive LNS-Child with no added flavor. |
| MNP-Child | Experimental | Dietary Supplement: Micronutrient powderThere will be 48 infant and young children(IYC) in this arm. They will receive MNP on day 2 and day 3. |
Who may qualify
- Ages
- 6 months to 49 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (11 listed)
- Pregnant women in their second or third trimester (in case of third trimester pregnancy, the expected date of delivery is not within three weeks) or lactating women with a child between 3 days and 6 months of age
- At least 18 years of age
- No life-threatening pregnancy-related complications (e.g., pre-eclampsia, antepartum hemorrhage)
- Apparently healthy and not presently suffering from an acute illness (e.g., fever, diarrhea, acute respiratory tract infection)
- Living in the study area for at least 6 months
Key exclusion criteria (2 listed)
- Known allergy to peanuts or other food products (as reported on the screening questionnaire)
- Severely malnourished [mid-upper arm circumference (MUAC) < 115 mm]
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 |
|---|---|---|
| Lipid-based nutrient supplementAlso: LNSLipid-based nutrient supplement for pregnant and lactating women | Dietary supplement | LNS-PLW |
| Lipid-based nutrient supplementAlso: LNSLipid-based nutrient supplement for infant and young children | Dietary supplement | LNS-Child |
| Micronutrient powderAlso: MNP, SprinklesMicronutrient powder for infant and young children | Dietary supplement | MNP-Child |
Primary outcome
Proportion of test dose consumed
Time frame: Day 2
Mean consumption of the test dose of LNS for PLW, LNS for IYC and MNP for IYC on day 2 (First test dose)
Proportion of test dose consumed
Time frame: Day 3
Mean consumption of the test dose of LNS for PLW, LNS for IYC and MNP for IYC on day 3(Second test dose)
4 secondary outcomes
Proportion of subjects liked the supplements
Time frame: Day 2
Proportion of subjects liked the supplement
Time frame: Day 3
Proportion of subjects liked the supplement
Time frame: Day 8
Proportion of subjects liked the supplement
Time frame: Day 15
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 23 Sep 2024.
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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.
Katnryn G Dewey, Ph.D. principal investigator
University of California, Davis
Malay K Mridha, MBBS,MPH study director
University of Callifornia, Davis
Camila M Chaparro, Ph.D. study director
Academy for Educational Development
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lipid-based nutrient supplement and Micronutrient powder in people with Malnutrition, run by University of California, Davis 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 11 inclusion and 2 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 23 Sep 2024. 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.
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?
Proportion of test dose consumed (time frame: Day 2). The study lists 2 primary outcomes in all. 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 23 Sep 2024.