SUBLINGUAL VITAMIN D 3 DRUG THERAPY IN VITAMIN D DEFICIENCY PATIENTS AT PRAVARA RURAL HOSPITAL

Vitamin D is involved in regulating the calcium homeostasis and exerts beneficial effects on skeletal health of the bones. Serum concentrations of 25hydroxyvitamin D (25[OH]D) are measured to assess vitamin D status, which is mainly determined by sunlight (ultraviolet-B [UV-B]) induced vitamin D production in the skin and, to a lesser extent, by dietary or supplemental vitamin D intake [1]. The Institution of Endocrinology Clinical Practice Guidelines pointed out that vitamin D deficiency was defined as a serum 25hydroxyvitamin D (25-OHD) content less than 20ng/mL (or 50nmol/L) [2].


INTRODUCTION
Vitamin D is involved in regulating the calcium homeostasis and exerts beneficial effects on skeletal health of the bones. Serum concentrations of 25hydroxyvitamin D (25[OH]D) are measured to assess vitamin D status, which is mainly determined by sunlight (ultraviolet-B [UV-B]) induced vitamin D production in the skin and, to a lesser extent, by dietary or supplemental vitamin D intake [1]. The Institution of Endocrinology Clinical Practice Guidelines pointed out that vitamin D deficiency was defined as a serum 25hydroxyvitamin D (25-OHD) content less than 20ng/mL (or 50nmol/L) [2].
The epidemic of vitamin D deficiency in India, irrespective of their age, gender, race is likely to significantly contribute to the increasing burden on the healthcare system. Traditional and social taboos often dictate lifestyle patterns such as clothing that may limit sun exposure and vegetarianism which certainly limits vitamin D abundant dietary options. Most Indians are vegetarians, and they are socioeconomically backward people constitute a large percentage of the population in India. The underprivileged generally suffer from overall poor nutrition.
Vitamin D rich dietary sources are limited and unaffordable to most of the Indians. Vitamin D supplements are available, but most Indians are not aware that they need additional vitamin D. Additionally, the cost of these supplements is essentially prohibitive to the majority. Fortification of staple foods with vitamin D may prove to be a more viable solution towards attaining vitamin D sufficiency in India [3].
Vitamin D is endogenously synthesized in human beings from photoconversion of 7-dehydrocholesterol in the skin to cholecalciferol on exposure to ultraviolet radiation of sun. In a tropical country like India, where sunlight exposure is abundant, vitamin D deficiency seems unlikely. However, as opposed to this, various studies have highlighted that 70-100% Indians in different age groups vitamin D insufficient or deficient [4].
Comparing to commonly used capsules, tablets of oral dosage forms, the sublingual absorption is generally faster and more efficient. The percentage of each dose absorbed is generally higher than that achieved by oral ingestion. To reach a systemic circulation of administered sublingually is reached within 10-15 minutes, which is much faster than when ingested orally [5].
The aim of this paper is to impress upon the practicing physicians in India about the gravity of the vitamin D deficiency problem throughout India, so that they may take necessary caution and care in the diagnosis and treatment of vitamin D deficiency [4].

Objective:
To study the age-wise distribution of the participants, estimation of serum vitamin D level before and after therapy of sublingual vitamin D 3 drug.

Study design: This was an Interventional study
Ethics approval: The study was registered in the Clinical Trial Registry of India and the International

ABSTRACT
The present study was aimed to study the effect of Sublingual Vitamin D 3 on Serum Vitamin D level in Vitamin D deficiency patients. This was a cross-sectional and interventional study. All the Vitamin D deficiency patients of age 18-60years and either gender, willing to participate in the study were included. Patients who had greater than 20 ng/ml were excluded from the study. The total number of participants in our study was 200, out of these 111 males and 89 females, the mean age in our study was 51.07 ± 7.39Yrs. All volunteers were given sublingual vitamin D3 (60,000IU) in six doses every fifteen days of follow up for 3 months. The subject's serum 25(OH)D levels were estimated before and after treatment of sublingual vitamin D3. There was statistically significant difference in serum vitamin D3 level before 16   The reason for the possible difference in the pattern for young and old subjects is uncertain. The higher body mass index in the older group could have had an effect or possibly the liver 25-hydroxylase reached its maximum capacity earlier (that is at a lower precursor concentration) in the older subjects, thus blunting the induced rise in calcidiol. Some other explanations must be sought for the slower rate of decline in the older subjects. Metabolic consumption appears to be slower. By itself, this would have been predicted to lead not only to a slower clearance but to a higher initial concentration as well. so, there is seemingly a need to invoke two differences in the handling of vitamin D between the younger and older ages [13].

RESULTS
Estimated of serum 25(OH)D level according to the participants ( Vitamin D deficient patients were treated with oral Vitamin D3 15,000 IU daily. There was statistically significant increase in mean serum Vitamin D from 16.55± 1.93to 51.9± 3.1 ng/ml [20]. Miles D. Witham et al randomized clinical trial observed in serum 25(OH) D levels increased from at the baseline level of 18 to 28 ng/ml after treatment of 100000 U of oral cholecalciferol every 3 months for one year [21]. Above the all the studies vitamin D was administered orally daily was given for longer duration whereas, in our study sublingual vitamin D3, 60,000 International Units was given every 15 days here the results are showing the increased serum vitamin D level might be the sublingual route of administration of vitamin D3 is the novelty of our study.

CONCLUSION
The sublingual route of vitamin D3 therapy showed the increase of serum vitamin D levels significantly in Vitamin D deficiency patients.