This Academy member benefit temporarily has been made public to allow all practitioners access to content that may assist in patient care during the national pandemic response. Click here for information on joining the Academy. 

HIV/AIDS

H/A: MNT (2009)

Citation:

Rabeneck L, Palmer A, Knowles JB, Seidehamel RJ, Harris CL, Merkel KL, Risser JMH, Akrabawi SS. A randomized controlled trial evaluating nutrition counseling with or without oral supplementation in malnourished HIV-infected patients. J Am Diet Assoc. 1998; 98: 434-438.

PubMed ID: 9550167
 
Study Design:
Randomized Controlled Trial
Class:
A - Click here for explanation of classification scheme.
Quality Rating:
Negative NEGATIVE: See Quality Criteria Checklist below.
Research Purpose:

The objective of this study was to evaluate the effects of nutrition counseling with or without oral supplementation on malnourished HIV-infected patients.

Inclusion Criteria:

To be eligible for this study subjects had to be:

  • Men
  • Age 18 years or older
  • CD4+ cell count fewer than 500 cells per cubic millimeter
  • Less than 90% usual weight-for-height or had an involuntary weight loss of more than 10% body weight in the previous six months
  • Able to care for themselves as denoted of a Karnofsky score of 50 or more
  • Life expectancy of at least 12 weeks
  • If receiving drug therapy, the regimen must have been unchanged for eight weeks.

 

Exclusion Criteria:
  • Dysphagia
  • Severe diarrhea (more than six watery stools per day for seven or more days)
  • Cytomegalovirus or Mycobacterium avium complex infection
  • Suspected or treated infection (fever, chills)
  • Diagnosis of infection or hospitalization within the preceding two weeks
  • Receiving anabolic agents, appetite stimulants or chemotherapy.
Description of Study Protocol:

Recruitment

HIV-infected patients were recruited from three sources: the Houston Veterans Administration Medical Center Special Medicine clinic, an outpatient facility for HIV-infected veterans; the Thomas Street Clinic, an outpatient facility that serves Harris County (Texas) and the private practices of several physicians in the Houston, TX, area.

Design

The study consisted of a two-week baseline period followed by a six-week treatment period. During the baseline period, patients were seen at weekly intervals (visit one, visit two). At visit one, a history and physical examination were completed, the Karnofsky score was determined and a blood sample was obtained for analysis. A 24-hour dietary recall was obtained. Each patient was instructed about how to use the three-day food records that were to be completed and returned at all subsequent visits. At visit two and all subsequent visits, nutritional status, grip strength, cognitive function and quality-of-life were assessed. At visit three, patients were randomly assigned to either a normal diet (control group) or a normal diet plus oral supplement (supplement group) for six weeks. All patients in both groups received individual nutritional counseling and were told how to consume a diet intended to achieve a specific energy target (approximately 960kcal per day more than estimated total energy expenditure). Patients were seen every two weeks during the treatment period. When a patient's dietary intake did not achieve the energy target, he was counseled by the study dietitian.

Blinding used

Not possible.

Intervention

The supplemented group was provided with a specialized, medium-chain triglyceride formula suitable for HIV-infected patients with fat malabsorption.

Statistical Analysis

Fisher's exact test was used to evaluate differences in study discontinuation rates and adverse event rates in the treatment groups. All P values were based on two-tailed tests. Differences in baseline variables and in end-point change from baseline were evaluated using either analysis of variance (for baseline age, Karnofsky score, body mass index); and for end-point change in weight, cognitive function, quality-of-life or the Wilcoxon rank sum test (for baseline weight, cognitive function, quality-of-life and of baseline and end-point change in laboratory, skinfold thickness, bioelectrical impedance and grip-strength measurements). Analysis of covariance was also used to evaluate end-point change from baseline in quality-of-life scores.

Data Collection Summary:

Timing of Measurements

Measurements were done at baseline and then every two weeks during the six-week treatment phase.

Dependent Variables

  • Nutritional parameters (weight, height, skinfold thickness, grip strength, body composition measures) 
  • Cognitive function (Buschke selective reminding test, which evaluates recall, short-term recall, long-term storage, long-term retrieval and consistent long-term retrieval)
  • Quality-of-life (self-administered questionnaire developed for this study, evaluates physical, emotional function, burden of symptoms and sense of well-being).

Independent Variable

Nutrition counseling only vs. nutrition counseling plus oral supplement.

Control Variables

  • HIV status
  • Sex.
Description of Actual Data Sample:

Initial N: 118 men (59 in each treatment group)

Attrition (final N): 99 (49 in supplement group, 50 in the control group)

Age: Mean age: supplementation group, 39 years; control group, 41 years

Ethnicity: Not mentioned

Anthropometrics: Only significant difference between groups is that the total quality-of-life score was higher in the control group (P=0.025) than the supplement group

Location: Houston, Texas.

 

Summary of Results:

Other Findings

There were no significant differences in hematologic parameters, CD4+ cell count or serum albumin level. The control group had a median increase in serum triglyceride level of 0.55mmol per liter compared with an increase of 0.02mmol per liter in the supplement group (P=0.04).

No significant differences were observed in weight, body fat, skinfold thickness, grip strength or fat-free mass. There was a significant difference between groups in total body water (change from baseline 0.6kg±0.5kg in supplement group, -0.4kg±0.3kg in control group, P=0.039). Patients in the supplement group experienced improvement in short-term recall (P=0.029) and long-term storage (P=0.047). No difference the total quality-of-life scores was detected.

The proportions of patients in the supplement (56%) and control (50%) groups who achieved 80% or more of energy target were not significantly different.

 

Author Conclusion:

In the short term, nutrition counseling with our without oral supplementation can achieve a substantial increase in energy intake in approximately 50% of malnourished HIV-infected patients. Further study is needed to evaluate the effects of longer treatment periods on patient outcomes.

Funding Source:
Reviewer Comments:
  • Caloric intake not measured in groups at baseline
  • Off the 19 subjects not completing the study, 17 did so for "unrelated reasons." It would have been important to know what those reasons were.
  • Potential bias in measurements, especially cognitive function and quality-of-life tests
  • Protocol for supplementation not well-described.
Quality Criteria Checklist: Primary Research
Relevance Questions
  1. Would implementing the studied intervention or procedure (if found successful) result in improved outcomes for the patients/clients/population group? (Not Applicable for some epidemiological studies) Yes
  2. Did the authors study an outcome (dependent variable) or topic that the patients/clients/population group would care about? Yes
  3. Is the focus of the intervention or procedure (independent variable) or topic of study a common issue of concern to dieteticspractice? Yes
  4. Is the intervention or procedure feasible? (NA for some epidemiological studies) Yes
 
Validity Questions
1. Was the research question clearly stated? Yes
  1.1. Was (were) the specific intervention(s) or procedure(s) [independent variable(s)] identified? Yes
  1.2. Was (were) the outcome(s) [dependent variable(s)] clearly indicated? Yes
  1.3. Were the target population and setting specified? Yes
2. Was the selection of study subjects/patients free from bias? Yes
  2.1. Were inclusion/exclusion criteria specified (e.g., risk, point in disease progression, diagnostic or prognosis criteria), and with sufficient detail and without omitting criteria critical to the study? Yes
  2.2. Were criteria applied equally to all study groups? Yes
  2.3. Were health, demographics, and other characteristics of subjects described? Yes
  2.4. Were the subjects/patients a representative sample of the relevant population? ???
3. Were study groups comparable? ???
  3.1. Was the method of assigning subjects/patients to groups described and unbiased? (Method of randomization identified if RCT) Yes
  3.2. Were distribution of disease status, prognostic factors, and other factors (e.g., demographics) similar across study groups at baseline? ???
  3.3. Were concurrent controls or comparisons used? (Concurrent preferred over historical control or comparison groups.) Yes
  3.4. If cohort study or cross-sectional study, were groups comparable on important confounding factors and/or were preexisting differences accounted for by using appropriate adjustments in statistical analysis? N/A
  3.5. If case control study, were potential confounding factors comparable for cases and controls? (If case series or trial with subjects serving as own control, this criterion is not applicable.) N/A
  3.6. If diagnostic test, was there an independent blind comparison with an appropriate reference standard (e.g., "gold standard")? N/A
4. Was method of handling withdrawals described? ???
  4.1. Were follow-up methods described and the same for all groups? Yes
  4.2. Was the number, characteristics of withdrawals (i.e., dropouts, lost to follow up, attrition rate) and/or response rate (cross-sectional studies) described for each group? (Follow up goal for a strong study is 80%.) ???
  4.3. Were all enrolled subjects/patients (in the original sample) accounted for? Yes
  4.4. Were reasons for withdrawals similar across groups? ???
  4.5. If diagnostic test, was decision to perform reference test not dependent on results of test under study? N/A
5. Was blinding used to prevent introduction of bias? N/A
  5.1. In intervention study, were subjects, clinicians/practitioners, and investigators blinded to treatment group, as appropriate? N/A
  5.2. Were data collectors blinded for outcomes assessment? (If outcome is measured using an objective test, such as a lab value, this criterion is assumed to be met.) N/A
  5.3. In cohort study or cross-sectional study, were measurements of outcomes and risk factors blinded? N/A
  5.4. In case control study, was case definition explicit and case ascertainment not influenced by exposure status? N/A
  5.5. In diagnostic study, were test results blinded to patient history and other test results? N/A
6. Were intervention/therapeutic regimens/exposure factor or procedure and any comparison(s) described in detail? Were interveningfactors described? No
  6.1. In RCT or other intervention trial, were protocols described for all regimens studied? Yes
  6.2. In observational study, were interventions, study settings, and clinicians/provider described? Yes
  6.3. Was the intensity and duration of the intervention or exposure factor sufficient to produce a meaningful effect? ???
  6.4. Was the amount of exposure and, if relevant, subject/patient compliance measured? No
  6.5. Were co-interventions (e.g., ancillary treatments, other therapies) described? No
  6.6. Were extra or unplanned treatments described? No
  6.7. Was the information for 6.4, 6.5, and 6.6 assessed the same way for all groups? Yes
  6.8. In diagnostic study, were details of test administration and replication sufficient? N/A
7. Were outcomes clearly defined and the measurements valid and reliable? ???
  7.1. Were primary and secondary endpoints described and relevant to the question? Yes
  7.2. Were nutrition measures appropriate to question and outcomes of concern? No
  7.3. Was the period of follow-up long enough for important outcome(s) to occur? ???
  7.4. Were the observations and measurements based on standard, valid, and reliable data collection instruments/tests/procedures? Yes
  7.5. Was the measurement of effect at an appropriate level of precision? ???
  7.6. Were other factors accounted for (measured) that could affect outcomes? ???
  7.7. Were the measurements conducted consistently across groups? Yes
8. Was the statistical analysis appropriate for the study design and type of outcome indicators? ???
  8.1. Were statistical analyses adequately described and the results reported appropriately? Yes
  8.2. Were correct statistical tests used and assumptions of test not violated? Yes
  8.3. Were statistics reported with levels of significance and/or confidence intervals? Yes
  8.4. Was "intent to treat" analysis of outcomes done (and as appropriate, was there an analysis of outcomes for those maximally exposed or a dose-response analysis)? Yes
  8.5. Were adequate adjustments made for effects of confounding factors that might have affected the outcomes (e.g., multivariate analyses)? Yes
  8.6. Was clinical significance as well as statistical significance reported? Yes
  8.7. If negative findings, was a power calculation reported to address type 2 error? No
9. Are conclusions supported by results with biases and limitations taken into consideration? Yes
  9.1. Is there a discussion of findings? Yes
  9.2. Are biases and study limitations identified and discussed? Yes
10. Is bias due to study's funding or sponsorship unlikely? ???
  10.1. Were sources of funding and investigators' affiliations described? Yes
  10.2. Was the study free from apparent conflict of interest? ???