MalnutritionPhase 3NCT01641770
Oral Nutritional Supplementation in Hospital Patients
A Phase 3 study testing Nutritional beverage 10003RF and Dietary Counseling in people with Malnutrition, run by Abbott Nutrition at 13 sites in India.
Trial summary
The study objective is to evaluate the benefits of Oral Nutritional Supplementation (ONS) plus Dietary Counseling (DC) in newly admitted hospital subjects with moderate or severe malnutrition. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Malnutrition
- What is being tested?
- Nutritional beverage 10003RF and Dietary Counseling
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 212 participants
- Where
- 13 sitesIndia
- Study dates
- Oct 2010to Oct 2011
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ≥ 18 years of age
- Recently admitted into hospital ≤36 hrs.
- Identified as having "moderate malnutrition" or "severe malnutrition".
- Anticipated length of hospital stay of at least 3 days.
- Life expectancy of ≥ 12 weeks
- Able to consume foods and beverages orally.
- Willing to abstain from nutritional supplements throughout the study period unless provided be study.
Who cannot join
- Alcohol or substance abuse, severe dementia, brain metastases, eating disorders or any psychological condition that may interfere with dietary intake, severe nausea, dysphagia, vomiting, diarrhea, active gastritis, gastrointestinal bleeding or other gastrointestinal disturbances.
- Diabetes, burn injury covering greater than or equal to 15% of the body, advanced renal or hepatic disease, active malignancy.
- Ascites, pleural effusion, severe edema or dehydration.
- Severe edema.
- Medications/ supplements/substances that could profoundly modulate metabolism or weight
- Active tuberculosis, acute Hepatitis B or C, or HIV.
Trial locations and contacts
13 sites in 1 country.
13 sites in 1 country
India13 sites
King George Hospital / Andhra Medical College
Andhra Pradesh
St. Theresa's Hospital
Andhra Pradesh
Care Hospital- Hyderabad
Hyderabad
Advanced Medicare and Research Institute
Kolkata
Sengupta Hospital & Research Institute
Maharashtra
Lokmanya Tilak Muncipal Medical College & Lokmanya Thilak Municipal General Hospital
Mumbai
Seth GS Medical College and KEM Hospital
Mumbai
TN Medical College & BYL Nair Hospital
Mumbai
Abhinav Hospital
Nagpur
Sir Ganga Ram Hospital
New Delhi
Metro Multispecialty Hospital- X-1,Sector
Noida
Jehangir Clinical Development Centre Pvt. Ltd., Jehangir Hospital
Pune
Immunology at Dayanand Medical College & Hospital
Punjab
About this study
The study objective is to evaluate the benefits of Oral Nutritional Supplementation (ONS) plus Dietary Counseling (DC) in newly admitted hospital subjects with moderate or severe malnutrition.
Read the detailed description
Approximately 212 subjects (men and women) from multiple Institutions in India will participate in this study. Eligible subjects will be randomized into 2 treatment groups.
- Dietary Counseling only (n=106)
- Dietary Counseling + ONS (n=106)
- Conditions
- Malnutrition
- Being tested
- Nutritional beverage 10003RF, Dietary Counseling
- Medical subject headings
- Malnutrition
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nutritional beverage 10003RFOther
2 sachets per day
Dietary CounselingOther
Guidelines for dietary counseling include energy and nutrient requirements.
Dietary CounselingOther
Guidelines for dietary counseling include energy and nutrient requirements.
| Study group | Role | What they receive |
|---|---|---|
| Dietary Counseling + ONS | Experimental | Not described Receives: Other: Nutritional beverage 10003RF; Other: Dietary Counseling |
| Dietary Counseling | Active comparator | Not described Receives: Other: Dietary Counseling |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes from baseline in Body weight
Measured: baseline and weeks 4, 8, 12
Secondary outcomes (6)
Nutrition Assessment
Measured: baseline and week 12
BMI
Measured: baseline and week 12
Blood Chemistries (pre-albumin g/L, alpha-1 acid glycoprotein g/L)
values and changes from baseline
Measured: baseline and weeks 4,8,12
Blood Chemistries (albumin gm/dL, hemoglobin gm/dL, total protein gm/dL)
values and changes from baseline
Measured: baseline and weeks 4, 8, 12
Blood Chemistries (glucose mg/dL, creatinine mg/dL)
values and changes from baseline
Measured: Baseline and weeks 4,8,12
Blood Chemistries (c-reactive protein mg/L)
Values and changes from baseline
Measured: Baseline and weeks 4,8,12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jul 2012 (estimated)
- Study startOct 2010
- Primary completionJul 2011
- Study completionOct 2011
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
- None (open label)
- Enrolment
- 212 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 International-India
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01641770
- Sponsor's protocol ID
- BK83
- Status last verified
- Jul 2012
- First submitted
- 11 Jul 2012
- Last updated
- 17 Jul 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 17 Jul 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Oral Nutritional Supplementation in Hospital Patients
- ClinicalTrials.gov ID
- NCT01641770
- Acronym / sponsor ID
- BK83
- Conditions
- Malnutrition
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 212 participants (actual)
- Lead sponsor
- Abbott NutritionIndustry (pharma, biotech, devices)
- Study start
- Oct 2010
- Primary completion
- Jul 2011 (actual)
- Study completion
- Oct 2011 (actual)
- First posted
- 17 Jul 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 study objective is to evaluate the benefits of Oral Nutritional Supplementation (ONS) plus Dietary Counseling (DC) in newly admitted hospital subjects with moderate or severe malnutrition.
Detailed description
Approximately 212 subjects (men and women) from multiple Institutions in India will participate in this study. Eligible subjects will be randomized into 2 treatment groups.
- Dietary Counseling only (n=106)
- Dietary Counseling + ONS (n=106)
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dietary Counseling + ONS | Experimental | Other: Nutritional beverage 10003RF, Other: Dietary Counseling |
| Dietary Counseling | Active comparator | Other: Dietary Counseling |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- ≥ 18 years of age
- Recently admitted into hospital ≤36 hrs.
- Identified as having "moderate malnutrition" or "severe malnutrition".
- Anticipated length of hospital stay of at least 3 days.
- Life expectancy of ≥ 12 weeks
Key exclusion criteria (6 listed)
- Alcohol or substance abuse, severe dementia, brain metastases, eating disorders or any psychological condition that may interfere with dietary intake, severe nausea, dysphagia, vomiting, diarrhea, active gastritis, gastrointestinal bleeding or other gastrointestinal disturbances.
- Diabetes, burn injury covering greater than or equal to 15% of the body, advanced renal or hepatic disease, active malignancy.
- Ascites, pleural effusion, severe edema or dehydration.
- Severe edema.
- Medications/ supplements/substances that could profoundly modulate metabolism or weight
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 |
|---|---|---|
| Nutritional beverage 10003RF2 sachets per day | Other | Dietary Counseling + ONS |
| Dietary CounselingGuidelines for dietary counseling include energy and nutrient requirements. | Other | Dietary Counseling + ONS |
| Dietary CounselingGuidelines for dietary counseling include energy and nutrient requirements. | Other | Dietary Counseling |
Primary outcome
Changes from baseline in Body weight
Time frame: baseline and weeks 4, 8, 12
6 secondary outcomes
Nutrition Assessment
Time frame: baseline and week 12
BMI
Time frame: baseline and week 12
Blood Chemistries (pre-albumin g/L, alpha-1 acid glycoprotein g/L)
Time frame: baseline and weeks 4,8,12
Blood Chemistries (albumin gm/dL, hemoglobin gm/dL, total protein gm/dL)
Time frame: baseline and weeks 4, 8, 12
Blood Chemistries (glucose mg/dL, creatinine mg/dL)
Time frame: Baseline and weeks 4,8,12
Blood Chemistries (c-reactive protein mg/L)
Time frame: Baseline and weeks 4,8,12
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 17 Jul 2012.
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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.
Vinita Satyavrat, MD study chair
Abbott Nutrition International-India
13 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Nutritional beverage 10003RF and Dietary Counseling in people with Malnutrition, run by Abbott Nutrition at 13 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 7 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 17 Jul 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 13 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.
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?
Changes from baseline in Body weight (time frame: baseline and weeks 4, 8, 12). 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 17 Jul 2012.