Fatigue is a health issue experienced all-over the world. It is a symptom described among primary care. Persistence of this condition may lead to reduced quality of life and low productivity in life. Doctors have for a long time been prescribing vitamin D, iron and nutritional supplements as preventive treatment. However, this practice has been presumptive in nature because there is no proven scientific data to back it. This has led to uncertainty in the practice and its effectiveness and/or side effects, leaving a lot of medications to be dispensed without scientific backing of their effectiveness.
This essay is an evaluation and review of the article “Effects of vitamin D3 on self-perceived fatigue, a double-blind randomised placebo-controlled trial’ by Nowak at el (2016). The article discusses how a clinical trial investigated how vitamin D3 supplement affect symptoms of fatigue on individuals who are vitamin D deficient but healthy overall. These trials were the first to provide scientific prove about the effect of vitamin D3 on fatigue.
Details of the research
This research was aimed at testing how vitamin D3 supplements affects fatigued persons who are have a deficiency of vitamin D but are healthy overall. All ingredients needed for a successful research were applied. Firstly, the facilitators chose a research question that would address all the objectives of the research study and offer a process that is evidence-based. Secondly, choosing of the target population was done carefully while following a strict screening process (through use of inclusion an exclusion criteria). Thirdly, for intervention, a single dose of vitamin D3 supplement was administered on the subject population. Lastly, to effectively measure the outcome of the study, a 30-day post intervention assessment was done on the persons who perceived themselves to be fatigued.
Participation and allocation methods
The research used randomization method in its trials which gives every participant an equal chance of been allocated to either the experimental or control group. The method is effective if intervention is been applied on a highly controlled study population. It ensures even allocation of participants by establishing baseline similarity before intervention is implemented so as to avoid bias.
A strict inclusion and exclusion criteria were followed in order to guarantee baseline similarity. It involved performing blood analysis, fatigue assessment and physical examinations on the participants. The chosen participants were divided into two groups of equal numbers. The sequence used for allocation was hidden from both the investigators and participants so as to eliminate any bias in the system and ensure any of the participants could be allotted to nay of the two groups.
Lost participants
Out of the 122 participants chosen for the study, 59 were placed in the vitamin D group while 63 were placed in the placebo group. After baseline visit, two participants, one from each group were excluded because one disappeared and could not be followed-up while the other started taking anti-depressant medication (Venlafexine) which is an exclusion requirement. All other factors such as baseline characteristics and similarity between the two groups were kept constant to eliminate risks of bias in the research.
Evaluation of the methods
Double-blind studying – This is a research method where the participant and the investigators are paired blindly to the experimental group in order to get rid of behaviours which might affect the overall results of the study. The hosting pharmacy also made sure the placebo and vitamin D supplements were similar in appearance, smell, taste and packaging as well as labelling. The overall intend is to make all the study criteria as identical in both groups as possible.
Investigators also ensured all variables and baseline characteristics after screening process were balanced and any differences of the two groups with regard to prognosing the level of fatigue and vitamin D of the participants were eliminated. This was aimed at enabling the researcher to correctly determine the effects of the intervention since all other variables in the research are similar, except the application of the intervention itself.
How the two groups were handled
According to the article, the study protocol has details in the following areas of the study: –
- Treatment phase involve measuring of fatigue levels using FAS scale. Administration of vitamin D supplements or placebo was the only clinical intervention method implemented.
- 30 days after treatment, follow-up visits were made. They included fatigue measurements (using FAS scale), a FAS test and a clinical examination and laboratory analysis of blood samples.
- The study protocol required enrolment of participants to be done in separate periods of the year but baseline and treatment visits as well as follow-up visits was done at the same times. This also helped to capture participants medical details at different times of the year.
Results of the study
Effects of interventions administered
For accurate results, the research undertook the following measures: –
- To find out the effectiveness of the interventions, detailed measurements which included pre-and-post intervention testing of multiple variables were done.
- The variables (four of them) that were measured at baseline and during follow-up included all participants from the two groups.
- The FAS scale measurements of participants in the primary outcome ensured accurate assessment of changes in the self-perceived fatigue levels.
- Laboratory analysis of blood and urine specimens ensured the effects of vitamin D3 supplement was accurately measured in the secondary outcome.
- Lastly, more outcomes were achieved by measuring the effects of oral vitamin D3 supplements on fatigue using the FCA test.
The research methodology ensured there was no missing or incomplete data. The two participants who were excluded after baseline study did not affect the similarity of the baseline since each belonged to each group. All biases were eliminated and comparisons between the two groups was done through T and Chi-square tests. Pearson statistical tests were done to determine correlation between the two groups.
Benefits of the research intervention
For those administered with vitamin D supplement, it led to an increase n 24(OH)D levels in the experimental group. The mean FAS reduced drastically in the vitamin D group (p<0.0001) as compared to the placebo group (p=0.204). Additionally, there was reduction in secretion of PTH and an increase in 35(OH)D levels which meant the treatment was efficient.
Those among the participants who reported adverse effects of the intervention were similar in number in the two groups (vitamin D and placebo). Respiratory tract infection was the commonest mentioned adverse effect among the participants. It was attributed by the author of the study to a seasonal flu outbreak. No additional adverse effects or harm were reported from any of the two groups.
For costs of vitamin D deficiency treatment, a vitamin D3 supplement is available across all healthcare centres and pharmacies at an affordable price.
How the research can be applied to local population
The study only targeted individuals who are healthy overall but lack vitamin D and experience symptoms of fatigue. Targeting this highly controlled population was done deliberately so as to provide an accurate analysis of the effect of vitamin D deficiency on people with fatigue symptom. However, this means limits the results of the study and excludes older, mentally and physically sick persons. The targeted participants also had lower levels of vitamin D as opposed to the general population which tends to have milder vitamin D deficiency levels.
However, this research is the first one to provide clinical evidence supporting how vitamin D supplements are effective on people suffering from perceived fatigue. Prior to this study, doctors did not have scientific evidence backing the effectiveness of these drugs and were therefor forced to dispense a large variety of medications. The research provided them with evidence that narrowed down the number of medications to the specific ones which treat vitamin D3 deficiency.
Conclusion:
The above research was done using methodology that ensures all factors for a successful study are factored in. This meant that the results of the study were accurate and reliable due to the validity of the whole process. It is therefore fair to conclude that the results provided accurate evidence that vitamin D3 is effective in combating symptoms of fatigue in otherwise healthy individuals.
The results were however limited in their scope since the study had excluded other population groups such as older and sick people and mentally challenged individuals. Regardless of the limitations, the research was invaluable to provision of evidence based clinical care to medical practitioners treating people experiencing fatigue.