EAL

Cardiovascular Disease and Micronutrients

Citation:

Study Design:

Class:

- Click here for explanation of classification scheme.

Quality Rating:

Research Purpose:

The research purpose was to determine if supplemental vitamins C and E were effective in lowering serum lipids in healthy middle aged and older adults.

Inclusion Criteria:

No known cardiovascular disease
Aged 50 years or older.

Exclusion Criteria:

None listed.

Description of Study Protocol:

Recruitment: Volunteers from a university-based outpatient clinic
Design: Double-blind, placebo-controlled RCT (extensive randomization described)
Blinding used: Both subjects and investigators blinded.

Intervention

Group A (N=30): 1,000mg vitamin C
Group B (N=30): 100 IU vitamin E
Group C (N=30): Both 1,000mg vitamin C and 100 IU vitamin E
Group D (N=30): Placebo.

Statistical Analysis

Paired T-tests
ANOVA
Significance, P<0.05.

Data Collection Summary:

Timing of Measurements

Baseline and 75 days.

Dependent Variables

Total serum cholesterol
HDL-cholesterol
LDL-cholesterol
Triglycerides.

Independent Variables

Group A: 1,000mg vitamin C
Group B: 100 IU vitamin E
Group C: Both 1,000mg vitamin C and 100 IU vitamin E
Group D: Placebo.

Description of Actual Data Sample:

Initial N

120 (60 males, 60 females).

Attrition (Final N)

98 (19% attrition)

Group A (N=27): 1,000mg vitamin C
Group B (N=24): 100 IU vitamin E
Group C (N=26): Both 1,000mg vitamin C and 100 IU vitamin E
Group D (N=19): Placebo

Age

Range: 50 to 75 years
Mean: 60.5±7 years.

Ethnicity

Not described.

Anthropometrics

Investigators reported no significant differences at baseline, but:

Mean serum cholesterol of four groups ranged from 171mg to 206mg per dL at baseline
Mean triglyceride levels of four groups ranged from 152mg to 195mg per dL at baseline
Mean LDL-cholesterol levels of four groups ranged from 97mg to 130mg per dL at baseline.

Location

Lebanon.

Summary of Results:

Change in Serum Lipids

	Vit C		Vit E		Vit C&E		Placebo
	Pre	Post	Pre	Post	Pre	Post	Pre	Post
TG (mg/dL)	195	191	215	207*	152	144*	186	188
Cholesterol (mg/dL)	171	163*	178	167*	184	171*	206	212**
HDL-Cholesterol (mg/dL)	38	44*	32	43*	33	44*	37	36
LDL-Cholesterol (mg/dL)	97	80*	103	84*	121	101*	130	137*

* significantly different P<0.0001
**significantly different P<0.05.

Author Conclusion:

Supplementation with vitamins C and E can lower cholesterol and LDL levels and increase HDL levels in healthy middle-aged to older adults.

Funding Source:

Other:

Reviewer Comments:

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?	Yes
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?	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%.)	No
	4.3.	Were all enrolled subjects/patients (in the original sample) accounted for?	No
	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?		Yes
	5.1.	In intervention study, were subjects, clinicians/practitioners, and investigators blinded to treatment group, as appropriate?	Yes
	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?	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?		Yes
	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?	Yes
	6.4.	Was the amount of exposure and, if relevant, subject/patient compliance measured?	???
	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?	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?		Yes
	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?	Yes
	7.6.	Were other factors accounted for (measured) that could affect outcomes?	Yes
	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)?	???
	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?	No
	8.7.	If negative findings, was a power calculation reported to address type 2 error?	N/A
9.	Are conclusions supported by results with biases and limitations taken into consideration?		No
	9.1.	Is there a discussion of findings?	Yes
	9.2.	Are biases and study limitations identified and discussed?	No
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