GrowthNCT02056275
A Study of an Oral Nutrition Supplement (ONS) in Children.
A study testing Nutrition supplement + dietary counseling and Dietary Counseling in people with Growth, run by Abbott Nutrition at 8 sites in India.
Trial summary
To assess the effect of oral nutritional supplementation with dietary counseling versus dietary counseling alone on growth of preschool children over a period of 90 days. Read more about this study
- Who is it for?
- Ages 24 to 72 months
- Conditions the study is for
- Growth
- What is being tested?
- Nutrition supplement + dietary counseling and Dietary Counseling
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 256 participants
- Where
- 8 sitesIndia
- Study dates
- Aug 2013to Apr 2014
- 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 24 to 72 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Age of 24-72 months (inclusive), both genders.
- Diagnosed with current acute upper respiratory tract infection.
- Weight-for-age between 3rd - 15th percentile according to WHO Growth Charts.
- Identified as a picky eater.
- Able to consume foods and beverages orally.
- Willing to abstain from additional non-study provided protein supplements or nutritional supplements throughout the study period.
Who cannot join
- Current illness requiring hospitalization.
- Gastrointestinal infection and/or acute diarrhea at the time of inclusion in the study.
- Currently taking medication that could affect absorption/metabolism of study product or weight of the child.
- Diagnosed with recurrent respiratory infections due to cystic fibrosis, immunodeficiency syndromes, and congenital abnormalities of the respiratory tract, congenital lung and ciliary abnormalities, an unsuspected foreign body and asthma.
- Active tuberculosis, acute hepatitis B or C, or HIV, malignancy.
- History of diabetes mellitus.
Show all 9Show fewer
- Received antibiotic therapy within the last two weeks before start of the study.
- Dysphagia, aspiration risk, difficulty in swallowing due to acquired / congenital abnormalities that would hamper oral intake of the study product.
- Clinically significant nutritional deficiency requiring specific treatment with any other nutritional supplement (not study product).
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
India8 sites
Sangini Hospital
Ahmedabad, Gujarat, 380006
St. Theresa's Hospital
Hyderabad, Andhra Pradesh, 500018
Institute of Child Health
Kolkata, West Bengal, 700 017
Kasturba Medical College and Hospital
Manipal, Karnataka, 567104
TN Medical College & BYL Nair Hospital
Mumbai, Mumbai, 400 008
Seth GS Medical College and KEM Hospital
Mumbai-12, Mumbai
Noble Hospital
Pune, Maharashtra, 411013
Praveen Cardiac Centre
Vijayawada, Andhra Pradesh, 520002
About this study
To assess the effect of oral nutritional supplementation with dietary counseling versus dietary counseling alone on growth of preschool children over a period of 90 days.
- Conditions
- Growth
- Being tested
- Nutrition supplement + dietary counseling, Dietary Counseling
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nutrition supplement + dietary counselingOther
Also called Commercially available nutritional supplement.
Nutritionally balanced nutritional supplement providing 1.0 kcal/ml.
Dietary CounselingOther
Dietary counseling provided at each study visit by study dietitian.
| Study group | Role | What they receive |
|---|---|---|
| ONS + dietary counseling | Experimental | ONS/day + dietary counseling Receives: Other: Nutrition supplement + dietary counseling |
| Dietary counseling | Active comparator | Dietary counseling Receives: Other: Dietary Counseling |
What is being measured
The primary outcome is the main question the study is designed to answer.
Weight
Change in weight-for-age from Day 1 to Day 90
Measured: Study Day (SD) 1 to 90
Secondary outcomes (5)
Respiratory Infections
Number and duration of recurrent acute upper respiratory tract infections per month during the study period.
Measured: Study Day (SD) 1 to 90
Sick Days
Number of sick days per month assessed by the presence of any acute upper respiratory tract infections during the study period.
Measured: Study Day (SD) 1 to 90
Doctor Visits
Number of unscheduled visits per month due to development of acute upper respiratory tract infections during the study period.
Measured: Study Day (SD) 1 to 90
Dietary Intake
Average energy consumption (values and changes from baseline).
Measured: Study Day (SD) 1 to 90
Appetite Score
Change in appetite score (values and changes from baseline)
Measured: Study Day (SD) 3, 10, 30, 60 and 90
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2014 (estimated)
- Study startAug 2013
- Primary completionApr 2014
- Study completionApr 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for GrowthStudies 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 N/A
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 256 participants (actual)
Sponsor and investigators
- Lead sponsor
- Abbott Nutrition
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Vinita Satyavrat, MD, Study chair, Abbott Nutrition
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02056275
- Sponsor's protocol ID
- DA01
- Status last verified
- Oct 2014
- First submitted
- 4 Feb 2014
- Last updated
- 6 Mar 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study of an Oral Nutrition Supplement (ONS) in Children.
- ClinicalTrials.gov ID
- NCT02056275
- Acronym / sponsor ID
- DA01
- Conditions
- Growth
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 256 participants (actual)
- Lead sponsor
- Abbott NutritionIndustry (pharma, biotech, devices)
- Study start
- Aug 2013
- Primary completion
- Apr 2014 (actual)
- Study completion
- Apr 2014 (actual)
- First posted
- 5 Feb 2014 (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.
To assess the effect of oral nutritional supplementation with dietary counseling versus dietary counseling alone on growth of preschool children over a period of 90 days.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ONS + dietary counseling | Experimental | Other: Nutrition supplement + dietary counselingONS/day + dietary counseling |
| Dietary counseling | Active comparator | Other: Dietary CounselingDietary counseling |
Who may qualify
- Ages
- 24 to 72 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- Age of 24-72 months (inclusive), both genders.
- Diagnosed with current acute upper respiratory tract infection.
- Weight-for-age between 3rd - 15th percentile according to WHO Growth Charts.
- Identified as a picky eater.
- Able to consume foods and beverages orally.
Key exclusion criteria (9 listed)
- Current illness requiring hospitalization.
- Gastrointestinal infection and/or acute diarrhea at the time of inclusion in the study.
- Currently taking medication that could affect absorption/metabolism of study product or weight of the child.
- Diagnosed with recurrent respiratory infections due to cystic fibrosis, immunodeficiency syndromes, and congenital abnormalities of the respiratory tract, congenital lung and ciliary abnormalities, an unsuspected foreign body and asthma.
- Active tuberculosis, acute hepatitis B or C, or HIV, malignancy.
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 |
|---|---|---|
| Nutrition supplement + dietary counselingAlso: Commercially available nutritional supplement.Nutritionally balanced nutritional supplement providing 1.0 kcal/ml. | Other | ONS + dietary counseling |
| Dietary CounselingDietary counseling provided at each study visit by study dietitian. | Other | Dietary counseling |
Primary outcome
Weight
Time frame: Study Day (SD) 1 to 90
Change in weight-for-age from Day 1 to Day 90
5 secondary outcomes
Respiratory Infections
Time frame: Study Day (SD) 1 to 90
Sick Days
Time frame: Study Day (SD) 1 to 90
Doctor Visits
Time frame: Study Day (SD) 1 to 90
Dietary Intake
Time frame: Study Day (SD) 1 to 90
Appetite Score
Time frame: Study Day (SD) 3, 10, 30, 60 and 90
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 6 Mar 2015.
Related trials for Growth
Recruiting
Short-Term Reduced Dietary Protein in ER+/HER2- Breast Cancer Patients During Neoadjuvant Chemotherapy
Breast Cancer, Hormone Receptor Positive / HER2-negative Breast Cancer
RecruitingPhase 3
Adding an Immunotherapy Drug, MEDI4736 (Durvalumab), to the Usual Chemotherapy Treatment (Paclitaxel, Cyclophosphamide, and Doxorubicin) for Stage II-III Breast Cancer
Anatomic Stage II Breast Cancer AJCC v8, Anatomic Stage III Breast Cancer AJCC v8
RecruitingPhase 2
Study of Patritumab Deruxtecan Plus Pembrolizumab With Other Anticancer Agents in Participants With High-Risk Early-Stage Triple-Negative or Hormone Receptor-Low Positive/HER-2 Negative Breast Cancer (MK-1022-010, HERTHENA-Breast-03)
Breast Neoplasms, Breast Cancer
RecruitingPhase 1/2
A Study of VRN110755 in Patients With EGFR-Mutant Non-Small Cell Lung Cancer
EGFR-Mutant Non-Small Cell Lung Cancer
Active, not recruitingPhase 2
Safety, Preliminary Effectiveness of BNT327, an Investigational Therapy for Patients With Small-cell Lung Cancer in Combination With Chemotherapy
Extensive-stage Small-cell Lung Cancer, Small-cell Lung Cancer
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.
Vinita Satyavrat, MD study chair
Abbott Nutrition
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Nutrition supplement + dietary counseling and Dietary Counseling in people with Growth, run by Abbott Nutrition at 8 sites in India.
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 6 inclusion and 9 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 6 Mar 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in India. 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?
Weight (time frame: Study Day (SD) 1 to 90). 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 6 Mar 2015.