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Moderate Acute MalnutritionPhase 1NCT02272543

Acceptability and Efficacy of 'Fish Surimi Peptide' in Under Five Children Suffering From Moderate Acute Malnutrition

A Phase 1 study testing Fish surimi peptide in people with Moderate Acute Malnutrition, run by International Centre for Diarrhoeal Disease Research, Bangladesh at 1 site in Bangladesh.

Completed

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

Official record
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Trial summary

Protein-energy malnutrition (PEM) including moderate acute malnutrition (MAM: weight-for-height z-score <-2 to -3, or mid upper arm circumference (MUAC) 115 to < 125 mm) is a major cause of morbidity and mortality in under-5 children of developing/low-income countries. Read more about this study

Who is it for?
Ages 2 to 5 yearsHealthy volunteers can take part
Conditions the study is for
Moderate Acute Malnutrition
What is being tested?
Fish surimi peptide
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
100 participants
Where
1 siteBangladesh
Study dates
Oct 2014to Dec 2016
Phase
Phase 1
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 2 to 5 years
  • All sexes
  • Healthy volunteers accepted
  • Child

Who may be able to join

  • Signed informed consent from guardian
  • Ages 2 to 5 years
  • WHZ<-2 to -3or (MUAC) 115 to < 125 mm without any edema
  • Parent/guardian planning to stay in the same area for 3 to 4 months (for smooth follow up purpose)

Who cannot join

  • WHZ ≤ -3 z-scores or presence of bilateral pedal edema
  • History of allergy to any fish product
  • Anorexia, jaundice or chronic disease or any serious illness warranting hospital referral
  • Any congenital anomaly
  • Concurrent participation in another clinical trial with intervention to the child

Trial locations and contacts

1 site in 1 country.

Bangladesh1 site
  • icddr,b Dhaka Hospital

    Dhaka, 1212

Other trials in Bangladesh

About this study

Protein-energy malnutrition (PEM) including moderate acute malnutrition (MAM: weight-for-height z-score <-2 to -3, or mid upper arm circumference (MUAC) 115 to < 125 mm) is a major cause of morbidity and mortality in under-5 children of developing/low-income countries. Approximately 14.6% of all under-5 mortality worldwide is attributed to MAM. Prevalence of MAM among under-5 children in Bangladesh is ~12% (~1.7 million). Providing a diet containing adequate nutrients is the mainstay of treatment of children with MAM. Dietary protein is mostly derived from vegetable sources for the middle and low income population among whom the prevalence of MAM and other forms of PEM is high. It is now possible to process fish into fish peptides with longer shelf-life without refrigerator, known as 'fish Surimi' and consumed by different categories of people who need more well-balanced protein; this could be an attractive alternative to supply fish protein in the diet of children in low-income countries like Bangladesh.

Fish Surimi peptide is broken down from white fish meat using plant-derived enzyme and the ingredient is just fish meat consisted of 20 different kinds of amino acids including nine essential amino acids. In human studies it is found to help lowering blood lipids, glucose, IgE, hypertension, and increasing serum albumin and total protein, and bone density.

Read more

The present study is designed to assess acceptability and efficacy of 'fish Surimi' in 2-5 years old children suffering from MAM. A pilot study with two phases: to assess the i) acceptability with a small convenience sample (N=30) (phase 1); and ii) efficacy (rate of weight gain) of this fish peptide in a small convenience sample (N=70: 35 intervention 35 control) (phase 2) is proposed.

Acceptability trial (first phase): The investigators will conduct this study in the study ward of Dhaka Hospital of icddr,b. For each child the study will be for two days: i.e. direct observation of food intake of two lunches and two suppers. In a randomly manner and cross over design, an individual child will be offered 5g of fish Surimi during lunch and 5g during supper in one day or the same meal without any fish peptide on the other day in a blinded manner. The investigators will observe the completeness and eagerness of eating and any possible side effect (e.g. allergy, vomiting, diarrhea etc.) over these two days.

Pilot efficacy trial (second phase): The investigators will conduct a pilot trial to assess the efficacy (mainly on child weight gain) of fish Surimi given at home with various foods/meals in 2-5 years old children with MAM will be conducted in Dhaka City of Bangladesh. Children will be enrolled from the Dhaka Hospital of icddr,b after improvement of any acute illness. The intervention group will receive (as take home supplementation) two-week's ration of fish Surimi (@10g/day in two doses i.e. 5g + 5g each in airtight packet), which will be served twice daily mixed with family diet. The control group will not be provided any supplements but the parents will be given dietary advice to provide nutritious food to the child in adequate amounts, and children of both groups will receive micronutrient sprinkle. The child's guardian will be supplied with fish Surimi during initial discharge from icddr,b hospital and requested to come for a fortnightly follow up at the nutrition follow-up unit (NFU) of icddr,b. During each follow-up visit the study research assistant/health worker will do the anthropometry, collect morbidity history since the last visit/follow up and dietary history will also be taken to find out how the child is doing along with the fish Surimi intake. Treatment of any illness will be provided as per standard method by on duty physician of the Dhaka Hospital of icddr,b. The ration for next two weeks will be provided and in such way each child will be followed for ~ 3 months over six NFU-follow-up visits. To reduce the possible drop-out the both-way transportation cost (~ 150 to 250 taka) during each follow-up visit will be reimbursed to the guardians. In the middle of the two scheduled follow-up days the research assistant will call the family by cell phone to monitor the child's feeding and morbidity status. Approximately 5ml blood will be collected from the ante-cubital vein of the children for biochemical test on enrolment and at the end of 3 months and will be analyzed for haemoglobin (Hb), c-reactive protein, zinc, ferritin, albumin, total protein, and IgE. During the blood drawing days each child will be given a toy (take home).

Being tested
Fish surimi peptide

What participants receive

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

  • Fish surimi peptideDietary supplement

Study groups in NCT02272543
Study groupRoleWhat they receive
Fish surimi peptide powderActive comparatorFish surimi peptide powder
Receives: Dietary Supplement: Fish surimi peptide
PlaceboPlacebo comparatorPlacebo
Receives: Dietary Supplement: Fish surimi peptide

What is being measured

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

  1. Primary outcome measures: Weight gain after serving the test diet for 12 weeks: changes in body weight during the study period will be measured and 'weight-for-height Z-score 'will be calculated.

    Measured: 12weeks

Timeline

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

  1. First posted23 Oct 2014 (estimated)
  2. Study startOct 2014
  3. Primary completionDec 2016
  4. Study completionDec 2016

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 1
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
100 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02272543
Sponsor's protocol ID
PR-14047
Status last verified
Jun 2016
First submitted
21 Oct 2014
Last updated
25 Sep 2017
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Fish surimi peptide in people with Moderate Acute Malnutrition, 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 4 inclusion and 5 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 25 Sep 2017. 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. Some participants in this study may receive a placebo. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

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?

Primary outcome measures: Weight gain after serving the test diet for 12 weeks: changes in body weight during the study period will be measured and 'weight-for-height Z-score 'will be calculated. (time frame: 12weeks). 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 25 Sep 2017.

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