Setting Standards Across the Pharma Value Chain
( Sublingual Vitamin d3 spray)
One spray 250iu
MERKURY ARENA LABS
SL D3 Spray is an optimum strength daily oral vitamin D spray. Specially formulated to deliver vitamin D directly into the bloodstream by passing the digestive system
A spray provides the active ingredient in micro-sized droplets. The plume of the spray is designed to coat the inside of the mouth, in particular the buccal membrane of the inner cheek.
Vitamin D helps in the maintenance of bones and teeth, supports a normal,
healthy immune system and contributes to a normal muscle function.
SL D3 Spray vitamin D oral spray guarantees a nutritional dosage that traditional tablets, capsules and drops (which all rely on an increasingly inefficient digestive system) simply can’t. By delivering 250IU of vitamin D per spray, SL D3 Spray provides the optimum daily dosage.
How SL D3 Sprays work?
Each spray produces a plume of micro-droplets that permeate the soft-tissue of the inner cheek, delivering essential nutrients into the rich vein system below. Micro-emulsified to product optimal droplet size and plume delivery, ensuring effective absorption and a convenience, speed and effectiveness other vitamin D supplements can’t.
How To Use SL D3 Spray
Carefully SL D3 spray into your mouth or on the inside of your cheek. Take one spray daily or as directed by your health practitioner.
Multiple sprays can be taken where a higher dosage is required. As general guidance, we recommend 1000IU (25mcg) per 25kg of body weight as a daily maintenance dosage.
Does not need to be taken with food or water and can be taken at any time of the day.
Once opened, use within 6 months.
Store at room temperature and out of direct sunlight. Keep out of children’s reach.
Do not exceed recommended dosage.
Vitamin D supplementation for women during pregnancy
Vitamin D supplementation during pregnancy increases serum vitamin D concentrations at term. The clinical significance of this finding and potential use and safety of this intervention as a part of routine antenatal care are yet to be confirmed in high-quality trials.
RHL Commentary by Mazhar S.B
1. Introduction
Vitamin D deficiency or insufficiency is currently a global pandemic affecting some one billion of all ages and ethnic groups. Gestational vitamin D deficiency is common. Reports from developing (such as Bangladesh, India, Iran, Pakistan, Somalia) as well as developed countries (such as Australia, Finland, Japan, the Netherlands, United Kingdom and USA) show a high prevalence of vitamin D deficiency.
Maternal vitamin D deficiency in early pregnancy has been associated with elevated risk of gestational diabetes mellitus. Other associations with maternal vitamin D deficiency include increased risk of pre-eclampsia, preterm birth, low birth weight and cesarean section. A positive correlation has been seen between maternal and child vitamin D levels. Vitamin D has direct effects on the innate as well as adaptive immune systems. The American Academy of Pediatrics suggests measuring maternal vitamin D levels during prenatal care to ascertain the vitamin D status.
Many health organizations recommend vitamin D supplementation in pregnancy and lactation as it improves maternal vitamin D status during pregnancy and may protect against adverse gestational outcomes. The recommended doses range between 200–400 IU/day. The intake of vitamin D sufficient to achieve optimal blood concentration of 80 nmol /l or 32 ng /ml is greater than current recommendations. Suggested increased recommendations include 1000 IU/day, 5000 IU/week or a single dose of 200 000 or more. Vitamin D excess leads to hypercalcaemia and hypercalciuria associated with renal stones. Various animal and human studies show that fetal excess of vitamin D metabolites are unlikely to occur when maternal concentrations are within a normal range.
The objective of this Cochrane review (1) was to examine whether supplementation of vitamin D alone or in combination with calcium or other vitamins and minerals during pregnancy safely improves maternal and neonatal outcomes. This review updates a previously published review (2) and incorporates new evidence on the effects and safety of vitamin D supplementation in pregnancy for the well-being of the mother and the newborn.
2. Methods of the review
The review authors searched the Cochrane Pregnancy and Childbirth Group trials register, the WHO International Clinical Trials Registry Platform (ICTRP) and the Networked Digital Library of Theses and Dissertations. The authors also contacted different institutions including WHO Regional Offices, UNICEF, the Micronutrient Initiative (MI), the Global Alliance for Improved Nutrition (GAIN) and the US Centers for Disease Control and Prevention (CDC) to identify suitable studies. The inclusion criteria were randomized and quasi-randomized trials with randomization at the individual level, evaluating the effect of supplementation with vitamin D alone or in combination with other micronutrients for women during pregnancy.
Two review authors independently assessed the eligibility of studies against the inclusion criteria and extracted data from included studies. The risk of bias in the included studies was assessed using the criteria outlined in the Cochrane Handbook for Systematic Reviews of Interventions. For each outcome, the quality of the evidence was assessed using the Grading of Recommendations Assessment, Development and Evaluation (GRADE) approach. A study was assessed as high-quality if it had low risk of bias in both the randomization and allocation concealment and additionally a low risk of bias in either blinding or loss to follow up. For dichotomous data, the results were presented as average risk ratio (RR) with 95% confidence interval (CI). For continuous data, the mean differences (MD) were measured. The authors pragmatically decided not to conduct subgroup analyses for those outcomes which had been reported in only three or fewer trials. Sensitivity analysis was not performed as only one study was considered to be of high quality.
Trials evaluating the benefits of vitamin D alone or in combination with other micronutrients in pregnant women of any gestational age, parity (number of births) and number of fetuses were included as long as the intervention and the control group were treated similarly. The primary outcome measures included risk of pre-eclampsia, gestational diabetes, and maternal vitamin D status at term as well as preterm birth and low birth weight. The secondary outcome measures were impaired glucose tolerance, cesarean section, gestational hypertension, side-effects and death. For the infant, secondary outcome measures were birth weight, length, head circumference, Apgar score, stillbirth, neonatal death, admission to neonatal intensive care unit, neonatal infection and very preterm birth (less than 34 weeks’ gestation).
The methods used by the authors to perform the literature search, extract data from eligible studies, assess quality of included studies, and analyse data and present findings were appropriate.
3. Results of the review
The search strategy identified six trials involving a total of 1023 women. Eight studies were excluded due to lack of randomization or were without placebo control. Ten studies were still ongoing at the time of publication of the review. Five of the included trials involving 623 women had compared the effects of vitamin D alone versus no supplementation/placebo and one trial with 400 women had compared the effects of vitamin D and calcium versus no supplementation. The included studies had been mostly carried out in the 1980s; one trial had been completed in 2008. The study settings were France, India and the United Kingdom. The latitude of settings was north of tropic of cancer and the seasons during which the studies were conducted varied. With the exception of one study, lack of reporting on attrition, missing data and lack of intention to treat analysis were regarded by the review authors to be serious problems in the studies.
Only one trial with 400 women reported on pre-eclampsia. Women who had received 1200 IU vitamin D along with 375 mg of elemental calcium per day were as likely to develop pre-eclampsia as women who had received no supplementation (average RR 0.67, 95% CI 0.33–1.35). Four trials involving 414 women consistently showed that women who had received vitamin D supplements had higher concentrations of vitamin D in serum at term than those who had received no intervention or a placebo. However, the magnitude of the effects of higher levels of vitamin D in the serum was highly heterogeneous. Data from three trials involving 463 women suggested that women who had received vitamin D supplements during pregnancy were less likely to have a baby with a birth weight below 2500 grams than those receiving no treatment or placebo; statistical significance of this finding was borderline (RR 0.48, 95% CI 0.23–1.01).
In terms of other conditions, there were no significant differences in adverse side-effects: nephritic syndrome (RR 0.17; 95% CI 0.01–4.06; one trial, 135 women); stillbirths (RR 0.17; 95% CI 0.01–4.06; one trial, 135 women); neonatal deaths (RR 0.17; 95% CI 0.01–4.06; one trial, 135 women) between women who had received vitamin D supplements in comparison with those who had received no treatment or placebo. No studies reported on preterm birth, maternal death, admission to neonatal intensive care unit or special nursery or Apgar scores.
4. Discussion
4.1 Applicability of the results
Vitamin D supplementation during pregnancy improves maternal serum vitamin D levels at term. However, currently there is insufficient high-quality evidence relating to the clinical effects of vitamin D supplementation during pregnancy. The usefulness and feasibility of this intervention as a part of routine antenatal care awaits the results of further trials. The findings of this review are applicable to all settings.
4.2 Implementation of the intervention
The cost of Vitamin D supplementation, alone or in combination with calcium and micronutrients, and the side-effects profile of vitamin D is favorable for use in under-resourced settings. If ongoing high-quality trials confirm benefits of vitamin D supplementation in pregnancy, such an intervention would be feasible without much strain on health systems owing to existing experience of provision of dietary supplementations in under-resourced settings.
4.3 Implications for research
Further rigorous randomized trials are required to evaluate the role of vitamin D supplementation during pregnancy. Future research should evaluate if an increase of serum 25-hydroxyvitamin D concentration is associated with improved maternal and infant outcomes in heterogeneous populations with different degrees of skin pigmentation, body mass index and settings. Information on the timing of initiation of vitamin D supplementation, the most effective and safe dosage, supplementation regimen (daily, intermittent or single doses), and the effect of vitamin D when combined with other vitamins and minerals is also needed for policy-making.