EAL

H/A: Micronutrient Supplementation (2009)

Citation:

Study Design:

Class:

- Click here for explanation of classification scheme.

Quality Rating:

Research Purpose:

To describe the dietary, demographic and health characteristics of HIV-infected persons who use different types of dietary supplements.

Inclusion Criteria:

Participants in the Nutrition for Healthy Living cohort
Age 18 years or older
Documented HIV infection.

Exclusion Criteria:

Pregnancy
Diabetes
Thyroid disease
Malignancies other than those associated with HIV at enrollment
Inadequate fluency in English
Excluded if they had not completed a three-day food record within a specified time or if the food record was marked unreliable.

Description of Study Protocol:

Recruitment

Participants of the Nutrition for Healthy Living cohort.

Design

Cross-sectional analysis of a cohort.

Intervention

Dietary supplement use was assessed
Each patient was categorized in one of four dietary supplement groups.

Statistical Analysis

All statistical comparisons were made by testing differences among the four treatment groups separated by sex
Macronutrient variables were generally normally distributed, and between-group comparisons were tested using one-way ANOVA with Tukey post-hoc tests
Statistical comparisons for micronutrients were conducted on logged variables because the data were skewed and medians were calculated.

Data Collection Summary:

Timing of Measurements

Participants had semiannual clinic visits during which medical, nutritional, dietary, body composition and quality-of-life data were collected.

Dependent Variables

Weight, height, BMI
Skinfold measurements (triceps, subscapular and suprailiac)
Bioelectrical impedance analysis
Waist and hip circumference
Depression measured using eight-item screening questionnaire
Fasting blood tested for immunologic, biochemical and nutritional markers.

Independent Variables

Use of dietary supplements and dietary assessment completed through three-day food records
Categorized into one of four groups: No supplement, vitamin and mineral supplement only, enteral nutrition or non-vitamin and non-mineral supplement.

Description of Actual Data Sample:

Initial N: 404 participants
Attrition (final N): 368 participants with valid three-day food records (100 females, 268 males).

Age, Ethnicity and Other Relevant Demographics

Variables	Age (Years)	White (%)	HIV RNA Level <200 Copies per ml (%)	Receiving Treatment (%)
Men: No supplement (N=97)	43.6±7.6	57	48	77
Men: Vitamin/mineral supplement (N=82)	46.4±9.1	57	55	76
Men: Enteral nutrition (N=25)	44.4±5.7	40	52	81
Men: Non-vitamin/non-mineral supplement (N=64)	46.9±7.2	83	66	89
Women: No supplement (N=46)	41.1±6.5	37	43	70
Women: Vitamin/mineral supplement (N=34)	42.4±6.6	29	50	68
Women: Enteral nutrition (N=12)	50.0±7.9	17	40	56
Women: Non-vitamin/non-mineral supplement (N=8)	43.6±7.5	100	75	80

Location

United States. Study centers in Boston, MA and Providence, RI.

Summary of Results:

Other Findings

Among men, 24% were taking non-vitamin/non-mineral supplements; 9%, enteral nutrition supplements; 31%, vitamin/mineral supplements; and 36%, no supplements.

Extremes in intake of micronutrients were common.

Across groups, inadequate intake of calcium was seen in men and inadequate calcium and iron intake was seen in women.

Men and women who consumed no supplements reported inadequate intakes of a number of micronutrients.

Men using non-vitamin/non-mineral supplements had diets higher in fiber (P<0.05), protein (P<0.05), and 13 of 14 vitamins and minerals.

Almost 90% of male non-vitamin/non-mineral supplement users ingested one or more vitamins or minerals in amounts above the tolerable upper limit.

Male non-vitamin/non-mineral supplement users were more likely to be white, well-educated and receiving highly active antiretroviral therapy and more likely to have higher annual incomes, higher CD4 counts and lower HIV RNA levels.

HIV-infected women who were using non-vitamin/non-mineral supplements exhibited similar trends.

Author Conclusion:

In conclusion, we found that extremes in intake of micronutrients were common. Men and women who consumed no supplements were found to have inadequate intake of a number of micronutrients. Also, many HIV-infected persons are taking multiple dietary supplements, sometimes in large doses. Non-vitamin/non-mineral supplement users are more likely to be white, well-educated and have higher incomes. They reported higher intakes of fiber, protein, vitamins and minerals. Many ingest very large amounts of vitamins and minerals, well above the recommended upper limit. Evaluation of the effects of megadose vitamins/minerals and non-vitamin/non-mineral supplements on the health of persons with HIV/AIDS is essential. Using current research as their guide, practitioners must teach persons living with HIV infection about adequate and safe levels of vitamin and mineral supplementation.

Funding Source:

Government:

GCRC Grant #M01-RR00054 and NIDDK Grant #2PODK45734

Reviewer Comments:

Less than 10 people in one group for the findings in women. Authors note the following limitations:

Small number of women in each group, making conclusions less relevant to women living with HIV infection
Analysis did not differentiate between nutrients supplied by diet alone and use of supplements
Details about type and number of supplements consumed is important and should also be assessed.

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)	N/A
	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)	N/A

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?		???
	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?		Yes
	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?	Yes
	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?	Yes
	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.)	Yes
	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?		Yes
	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%.)	Yes
	4.3.	Were all enrolled subjects/patients (in the original sample) accounted for?	Yes
	4.4.	Were reasons for withdrawals similar across groups?	N/A
	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?		Yes
	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.)	Yes
	5.3.	In cohort study or cross-sectional study, were measurements of outcomes and risk factors blinded?	Yes
	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?		Yes
	6.1.	In RCT or other intervention trial, were protocols described for all regimens studied?	N/A
	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?	N/A
	6.4.	Was the amount of exposure and, if relevant, subject/patient compliance measured?	N/A
	6.5.	Were co-interventions (e.g., ancillary treatments, other therapies) described?	N/A
	6.6.	Were extra or unplanned treatments described?	N/A
	6.7.	Was the information for 6.4, 6.5, and 6.6 assessed the same way for all groups?	N/A
	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?	Yes
	7.3.	Was the period of follow-up long enough for important outcome(s) to occur?	Yes
	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?		Yes
	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)?	N/A
	8.5.	Were adequate adjustments made for effects of confounding factors that might have affected the outcomes (e.g., multivariate analyses)?	N/A
	8.6.	Was clinical significance as well as statistical significance reported?	N/A
	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?		Yes
	10.1.	Were sources of funding and investigators' affiliations described?	Yes
	10.2.	Was the study free from apparent conflict of interest?	Yes