Main Research Findings

1) Daily administration of vitamin A resulted in positive clinical and endoscopic effects, as well as a decrease in disease index in patients with ulcerative colitis.

2) Application of vitamin A eye ointment resulted in the prevention of developing ocular surface disorder in patients in the ICU.

 

Selected Data

1) The research team of Masnadi et al conducted a double-blind, randomized controlled clinical trial designed to evaluate the therapeutic effects of vitamin A supplementation in patients with moderate ulcerative colitis. A total of 150 symptomatic patients aged 20 to 45 years, with Mayo scores ranging from 6 to 12, were selected to participate. These individuals had persistent symptoms despite being treated with both oral and topical 5-aminosalicylic acid, which is the standard therapy for ulcerative colitis .

Participants were excluded from the study if they were pregnant or planning pregnancy, breastfeeding, had other autoimmune or chronic infectious diseases, were regular users of vitamin A supplements, or were smokers. This ensured that the study population was relatively homogenous and free from confounding variables that could interfere with the outcomes of vitamin A supplementation [1].

Participants were randomly assigned into two groups: an intervention group and a placebo group. Randomization was carried out using computer-generated charts to minimize selection bias. Both patients and investigators were blinded to the treatment allocations, preserving the integrity of the double-blind design. The calculated sample size was based on detecting a 30% expected decrease in Mayo score. This calculation resulted in 70 subjects per group being necessary, but 75 were enrolled in each group to account for potential dropouts or protocol deviations.

The trial used a two-arm, parallel-group design. In both arms, the conventional treatment with 5-aminosalicylic acid remained stable for at least one month before the study began and continued throughout the trial duration. This helped isolate the effects of vitamin A as the independent variable. The intervention group received 25,000 IU of vitamin A daily in the form of retinyl palmitate, while the placebo group received identical-appearing soft gels containing no active vitamin. The supplementation period lasted for two months. Baseline anthropometric measurements were collected for all participants. Weight was measured to the nearest 0.1 kilogram, and height to the nearest 0.1 centimeter. From these measurements, body mass index was calculated using the standard formula [1].

The primary tool for assessing disease activity and treatment efficacy was the Mayo Clinic Score. This score is widely recognized for evaluating the severity and progression of ulcerative colitis. It includes four components: stool frequency, rectal bleeding, mucosal appearance based on endoscopic findings, and the physician’s global assessment of disease activity. For rectal bleeding and stool frequency, the worst score over the three days prior to each study visit was used to ensure accurate representation of the patient’s condition. The physician’s assessment included the patient’s own records of abdominal discomfort, general well-being, and physical examination findings, as well as performance status [1].

Mucosal inflammation, an important marker of disease activity, was assessed by an experienced gastroenterologist-endoscopist who specialized in inflammatory bowel disease. Each of the four Mayo score components was rated from 0 to 3, and the total score ranged from 0 to 12. A higher score indicated more severe disease.

Patient compliance with the treatment regimen was monitored by counting the number of unused soft gels. If patients consumed less than 80% of their prescribed capsules or altered their conventional medications during the trial, they were excluded from the final analysis to maintain study validity. The primary measure of treatment efficacy was the clinical response rate. A clinical response was defined as a decrease in the total Mayo score by at least three points or 30%, in addition to a decrease in the rectal bleeding subscore by at least one point or a final subscore of one or less. This definition ensured that both general symptom relief and specific improvements in bleeding were captured as meaningful outcomes [1].

Secondary efficacy outcomes included the proportion of patients achieving mucosal healing. Mucosal healing was defined as an endoscopic subscore of less than one, indicating minimal or no visible inflammation. This endpoint is important because it reflects not just symptomatic improvement but also resolution of the underlying disease process. The researchers also calculated the number needed to treat for both clinical response and mucosal healing. The number needed to treat provides a practical measure of treatment benefit, indicating how many patients would need to receive the intervention for one patient to benefit meaningfully [1].

2) The research team of Babamohamadi et al conducted a clinical trial on 38 intensive care unit patients to compare the effectiveness of two different eye care interventions, Vitamin A Eye Ointment and Moisture Chamber, in preventing ocular surface disorders, including dry eyes and corneal damage. Patients were selected through convenience sampling and had to meet specific inclusion criteria: they had to be over 18 years old, unconscious defined by a Glasgow Coma Scale < 8, admitted to internal or surgical ICUs, and have healthy corneal surfaces at the beginning of the study. Family consent was also required for participation [2].

Patients were excluded if they had preexisting ophthalmic conditions, facial or eye trauma, eyelid malposition, significant conjunctival edema or differences in edema severity between the eyes, Bell’s palsy, hemiplegia, or if they were discharged or deceased within the first three days of the intervention. Additionally, patients who regained partial consciousness defined as blinking more than five times per minute were also excluded.

The sample size of 38 was determined based on an initial pilot study involving 15 patients and calculated to ensure 80% statistical power. Data collection involved three main instruments: Fluorescein eye staining, Schirmer’s test, and a three-part questionnaire. The questionnaire’s first section captured demographic data such as age, gender, reason for ICU admission, comorbid conditions, and the Glasgow Coma Scale score, which were collected through patient medical records and interviews with family members [2].

The second section focused on factors that could influence the development of ocular surface disorders, such as eyelid position, presence and severity of conjunctival edema, use of respiratory aids, airway type, mechanical ventilation features, administration of analgesics and muscle relaxants, and use of tear-reducing or tear-inducing medications, including atropine, glibenclamide, tricyclic antidepressants, and antihypertensives [2].

The third section recorded clinical findings, including the results of Schirmer’s test on days one and five, daily fluorescein staining results, and the onset of keratitis if it occurred. All clinical assessments were carried out by the researcher to maintain consistency [2].

Fluorescein staining was then used to identify corneal damage, with abnormalities classified using the Oxford scale, a standard tool for grading corneal and conjunctival damage from A to E. This method involves applying a fluorescein strip moistened with normal saline to the conjunctiva and then examining the eye under cobalt blue light. A visible green pattern on the cornea indicates epithelial damage.

Dry eye was assessed using the Schirmer’s test, which involves placing a strip of special paper inside the lower eyelid without anesthesia and measuring tear production over five minutes. The moistened length of the paper indicated tear flow.

Ethical considerations were strictly adhered to throughout the study. These included obtaining approval from the university ethics committee, informed consent from the patients’ families, and assurances of confidentiality and voluntary participation. All eligible patients were screened within the first 12 hours of ICU admission, and baseline eye conditions were confirmed through fluorescein staining before beginning the interventions. Before the interventions began, all participating nurses received standardized training from the researcher on the application of both treatments and the eye rinse procedure. The nurses then conducted the interventions under the researcher’s supervision [2].

For the vitamin A eye ointment treatment, nurses applied a 2 cm strip of ointment to the lower conjunctival sac four times daily at specified intervals. The procedure required strict hygiene, including hand washing and wearing gloves, and care was taken to avoid contact between the ointment tube and the eye to minimize contamination or mechanical damage.

In the moisture chamber treatment, the eye was covered with a piece of plastic cover that extended from above the eyebrow to the cheekbone and was secured using hypoallergenic adhesive. This setup created a humid environment to protect the eye and was replaced twice daily. Both eyes were also rinsed with 5–10 cc of room-temperature normal saline during these sessions. The rinsing process was performed while the patient lay supine, with their head tilted slightly toward the treated eye to avoid contamination of the opposite eye. A syringe held 2.5 cm from the eye was used to deliver the saline. After rinsing, the eye area was dried using clean gauze in a motion from the inner to the outer corner to prevent infection spread [2].

Daily corneal evaluations using fluorescein staining occurred at 23:00, a time chosen for the lower ambient light levels, which helped in visualizing the staining patterns. The fluorescein strip was first moistened with saline to prevent epithelial damage, then applied to the lower conjunctiva. The patient’s eyelid was gently opened and closed to distribute the stain evenly, and excess dye was rinsed off after 30–60 seconds. The eye was then examined under blue light, and any damage was classified using the Oxford scale. Each eye was tested using a fresh strip to prevent cross-contamination, and the second eye was examined only after completing the evaluation of the first eye to avoid misinterpretation due to fluorescein diffusion [2].

To avoid bias, the nurse removed any residue from previous interventions before examinations. In cases of abnormal findings, an ophthalmologist conducted a confirmatory assessment. If the researcher and ophthalmologist disagreed on the classification, the ophthalmologist’s judgment prevailed [2].

 

Discussion

1) The research team of Masnadi et al presents the findings and conclusions of a randomized controlled clinical trial investigating the effects of vitamin A supplementation on patients with ulcerative colitis. Out of the original 150 participants, seven patients were withdrawn from the study: three from the vitamin A group and four from the placebo group. Consequently, data from 143 patients were included in the final analysis, with 72 in the vitamin A supplementation group and 71 in the placebo group [1].

Gastrointestinal side effects were relatively mild and more commonly reported in the vitamin A group. Ten participants in this group experienced nausea or a sense of abdominal fullness, compared to only three in the placebo group. These side effects were not severe enough in most cases to necessitate withdrawal from the study but are important to note when considering the tolerability of the intervention.

The mean age of the study participants was approximately 39.5 years, with a standard deviation of 12.7 years. The average body mass index was 26.8 kg/m², indicating that the population was generally overweight. At baseline, a statistically significant difference in anthropometric characteristics between the two groups was observed. Specifically, there was a higher prevalence of overweight and obese individuals in the intervention group compared to the placebo group. However, no significant differences were found between the groups in terms of age, duration of disease, serum vitamin A levels, or overall disease activity, suggesting that the groups were otherwise comparable at the start of the trial [1].

Following the intervention period, the vitamin A group exhibited significant improvements in several clinical parameters. There was a statistically significant decrease in the total Mayo score and its subscores, indicating reduced disease activity. Additionally, serum vitamin A levels increased significantly in this group, confirming the effectiveness of the supplementation. In contrast, the placebo group showed a significant decline in serum vitamin A levels, and there were no meaningful changes in their Mayo scores or subscores.

A one-way analysis of covariance was conducted to account for potential confounding factors, including age, sex, disease duration, BMI, and baseline values. After adjusting for these variables, significant differences between the two groups persisted in terms of serum vitamin A levels, total Mayo score, and its individual components. This further reinforces the effectiveness of vitamin A supplementation in improving clinical outcomes in ulcerative colitis patients [1].

In the vitamin A group, there was a noticeable shift toward milder disease. Specifically, the percentage of participants with mild or moderate inflammation increased, while the proportion of those with severe inflammation decreased. By the end of the study, 25% of the participants in the intervention group had achieved mild disease severity. Conversely, only 1.4% of participants in the placebo group experienced similar improvement, highlighting the superior anti-inflammatory effect of vitamin A.

In the vitamin A group, 34% of participants showed a clinical response, defined as a significant reduction in disease activity, while no clinical response was observed in the placebo group. Additionally, mucosal healing measured by endoscopic evaluation was achieved in 30.6% of the vitamin A group compared to only 8.5% in the placebo group. These differences were statistically significant demonstrating the clinical benefit of vitamin A supplementation in promoting mucosal repair and reducing inflammation [1].

The study also calculated the number needed to treat, which represents how many patients would need to be treated for one to benefit. For clinical response, the number needed to treat was three, meaning that treating three patients with vitamin A would result in one additional patient experiencing clinical improvement. For mucosal healing, the number needed to treat was five, suggesting that five patients would need to be treated for one to achieve healing of the intestinal lining. These values reflect strong therapeutic potential, especially for an accessible and affordable intervention like vitamin A [1].

In conclusion, this study provides evidence that daily supplementation with 25,000 IU of vitamin A for two months can lead to significant improvements in both clinical symptoms and mucosal healing in patients with ulcerative colitis. The intervention was generally well tolerated, with manageable side effects. Based on the number needed to treat values, the treatment appears effective, particularly for clinical response [1].

2) The research team of Babamohamadi et al conducted a clinical trial investigating the effectiveness of Vitamin A Eye Ointment and Moisture Chamber methods in preventing keratitis and dry eye among unconscious ICU patients. A total of 38 patients were studied, of whom 20 were female (52.6%) and 18 were male (47.4%). The average age of the patients was 69.8 years, ranging from 23 to 88 years old [2].

The severity of conjunctival edema did not significantly differ between the two treatment groups. However, in the vitamin A eye ointment group, a significant positive correlation was found between the severity of conjunctival edema and keratitis on the fourth day of the intervention, suggesting that worse edema was associated with more severe keratitis at that time point. This relationship, however, disappeared by the fifth day, indicating that the initial correlation did not persist. In the moisture chamber group, no statistically significant relationship between the severity of conjunctival edema and keratitis was found on either the fourth or fifth day, implying that the presence of edema in this group did not have a noticeable effect on keratitis development.

With respect to eyelid closure, most patients (47.2%) had full closure of both eyelids, thereby preventing corneal exposure. In only three patients, the eyelid positions differed by one grade, but the overall difference in eyelid position between the two treatment groups was not significant. In the vitamin A eye ointment group, a significant association was observed between eyelid position and the severity of keratitis on the fourth day, meaning that more open eyelids were linked to more severe keratitis. However, this relationship was no longer statistically significant on the fifth day . In contrast, the moisture chamber group showed no significant relationship between eyelid position and keratitis severity on either the fourth or fifth day, indicating that eyelid position was not a determining factor in keratitis progression in that group [2].

During the five-day observation period, keratitis developed in a total of three eyes (7.9%) in the vitamin A eye ointment group and seven eyes (18.4%) in the moisture chamber group. Despite this numerical difference, statistical analysis revealed that the difference in keratitis incidence between the two groups was not significant. This indicates that while fewer eyes were affected by keratitis in the vitamin A eye ointment group, the results do not provide strong enough evidence to confirm that vitamin A eye ointment was more effective than moisture chamber treatment in preventing keratitis overall [2].

Tear production was assessed using Schirmer’s test before and after the intervention. The vitamin A eye ointment group showed a statistically significant mean increase in tear production of 2.06 mm, demonstrating that vitamin A eye ointment positively impacted tear secretion. In contrast, the moisture chamber group experienced a slight average decrease in tear production of 0.15 mm, which was not statistically significant. When comparing the pre- and post-intervention results of both groups, it was found that vitamin A eye ointment significantly outperformed moisture chamber treatment in enhancing tear production, suggesting that vitamin A eye ointment may be more effective in preventing dry eye in unconscious ICU patients.

Fluorescein staining was performed daily to monitor the development of keratitis. On the first and second days, no signs of keratitis were detected in either treatment group, as all tests were negative. On the third day, one eye (2.6%) in the vitamin A eye ointment group tested positive for second-degree keratitis, while all others remained negative. By the fourth day, keratitis had developed in two eyes in the vitamin A eye ointment group and five eyes in the moisture chamber group. However, this increase was not statistically significant between the groups. Among the remaining 34 eyes in each group examined on the fifth day, keratitis was observed in two vitamin A eye ointment-treated eyes and four moisture chamber-treated eyes. Again, the difference in severity between the two groups was not statistically significant. Notably, one patient in the moisture chamber group who had exhibited first-degree keratitis on the fourth day showed complete recovery by the fifth day without any additional treatment, indicating that mild keratitis may resolve on its own with continued standard care [2].

In summary, the study found no statistically significant differences between the vitamin A eye ointment and moisture chamber treatment groups in terms of overall keratitis incidence or severity. However, certain transient relationships were noted in the vitamin A eye ointment group between conjunctival edema, eyelid position, and keratitis severity on the fourth day, though these relationships did not persist through the fifth day. Importantly, vitamin A eye ointment treatment significantly improved tear production as measured by Schirmer’s test, while moisture chamber treatment did not, suggesting that vitamin A eye ointment may be more beneficial in preventing dry eye. Despite the lack of statistically significant superiority in preventing keratitis, the trends observed favor vitamin A eye ointment in both lower keratitis incidence and better support of tear secretion [2].

 

Disclaimer

**LAB USE ONLY**
*This information is for educational purposes only and does not constitute medical advice. THE PRODUCTS DESCRIBED HEREIN ARE FOR RESEARCH USE ONLY. All clinical research must be conducted with oversight from the appropriate Institutional Review Board (IRB). All preclinical research must be conducted with oversight from the appropriate Institutional Animal Care and Use Committee (IACUC) following the guidelines of the Animal Welfare Act (AWA).



Citations

[1] Masnadi Shirazi K, Nikniaz Z, Masnadi Shirazi A, Rohani M. Vitamin A supplementation decreases disease activity index in patients with ulcerative colitis: A randomized controlled clinical trial. Complement Ther Med. 2018;41:215-219. doi:10.1016/j.ctim.2018.09.02

[2] Babamohamadi, H., Nobahar, M., Razi, J., & Ghorbani, R. (2018). Comparing Vitamin A and Moist Chamber in Preventing Ocular Surface Disorders. Clinical nursing research, 27(6), 714–729. https://doi-org.proxy.westernu.edu/10.1177/1054773817695618

 

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