Vitamin D Supplementation and Consequences of Vitamin D Deficiency in Pregnant Women

Running head: BIOLOGY ASSIGNMENT
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In the recent studies it has been observed that several conditions are responsible for
decreasing the Vitamin D concentration in mother that tends to cause severe effects in
mothers as well as in the fetus (Anatoliotaki et al. 2003). The low Vitamin D content during
pregnancy of a woman has been related with obstructed growth of the fetus and also show
severe impairment in the bone formation. The mothers with inadequate Vitamin D in their
body has shown to give birth to children with hypocalcaemia as well as rickets, and it has
been also observed in the masses where there is already Vitamin D deficiency (Hyppönen et
al. 2013). The elevated risk associated with skin diseases and lower respiratory tract infection
is associated with low cord serum 25-hydroxyvitamin D [25(OH) D], which mainly occurs
during first year of the child (Ioannou et al. 2012). Apart from these it has been observed
that with inadequate Vitamin D in mothers may also lead to the higher risk factors for
bacterial vaginitis, increase elevation of blood pressure, high protein urine (which can lead to
preeclampsia) and also gestational diabetes in pregnant mothers (Dawodu et al., 2013).
It has been observed that there is usual decrease of Vitamin D commonly happens
during pregnancy especially in Asian specifically in Indian women, which is less than
20ng/mL or < 50 nmol/L in the body fluid (Ioannou et al. 2012).
Numerous researches has been conducted in various part of the world in this
particular subject which shows that there is 74% vitamin D deficiency in women of
downtrodden mass during pregnancy, 98% Vitamin D deficiency of pregnant women in UAE
and 83% deficiency in Vitamin D in Kuwaiti pregnant women (Dawodu et al., 2013).
Further, it has also been reported that there is lack of supplements of this particular vitamin
and there is also less randomized control or RCTs trials in the population with high risk of
Vitamin D deficiency. The adequate amount of sufficient Vitamin D in the body has been
observed as more than 2000 IU/d which is optimum with 25(OH) D 32 ng/mL or may be
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greater than or equal to 80 nmol/L which is found in men as well as non pregnant women of
North America (Anatoliotaki et al. 2003).
Supplementing 100 IU of Vitamin D could increase the serum level of 25(OH) D by
0.4–0.8 ng/mL (1–2 nmol/L) which is a pharmacokinetic measure observed in adults.
Depending on such data as well as the high occurrence of vitamin D deficiency in the UAE
population, it is estimated that 4000 IU/d vitamin D3 supplementation would reach vitamin D
sufficiency. On the basis of this pharmacokinetic data, the increased rate of deficiency of
Vitamin D in endemic population can be overcome by supplementation of 4000 IU/d of
Vitamin D3.
This research has been an addition to the present ongoing protocol of National
Institutes of Health-funded study (NCT02292591), regarding the supplementation of 2000 as
well as 4000 I/d of Vitamin D3 among pregnant women in the country. A random control trial
was conducted by us, with the supplementation of Vitamin D on pregnant Indian women and
their children in UAE (Ioannou et al. 2012).
In the research conducted by us, the tested hypothesis confirmed that the required
vitamin D dose supplementation in order to improve the Vitamin D deficiency status in
pregnant women could be doses of 2000 or 4000 IU/d, and not 400 IU/d which a usual
standard recommended dose. It was also observed that 4000 IU is much superior in efficacy
that 2000 IU to gain the optimum and sufficient required Vitamin D for the mother’s infant
during birth without exceeding the toxic level of Vitamin D in the body. From the reports
from the literature review the priori cut off point of blood serum level 25(OH)D or 32 ng/mL
was found to be greater in case of Vitamin D sufficiency (Ioannou et al. 2012).
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2. THE STUDY OBJECTIVES
 The key objective and purpose of the research is to study VITAMIN D
SUPPLEMENTATION & CONSEQUENCES OF VITAMIN D DEFICIENCY IN
PREGNANT WOMEN.
 The study also aimed to understand the effectiveness and clinical
safety of 4000 IU and 2000 IU in the prenatal cases with respect to the standard
suggested dose of 400IU/d Vitamin D3.
3. LITERATURE REVIEW
The replacement of Vitamin D and the effect of deficiency of Vitamin D
among pregnant women during and the effect of deficiency of Vitamin D on fetus has
not been defined yet and remains questionable.
In a recent study by Hyppönen et al. (2013) it was proposed that vitamin D
has a vital role in skeletal development and its homeostasis of the infants during the
gestation period of the mother. It was also reported in the research publication which
was regarding craniobates that deficiency of Vitamin D can cause neo natal seizures
and newborns with hypocalcaemia.
During the gestation period the functioning of Vitamin D is very sensitive, and
the deficiency of the Vitamin D may lead to adverse effects on various systems of the
body which includes immune system, musculoskeletal, neural as well as
cardiovascular function of the newborn. Current studies determine the role of Vitamin
D and pregnancy consequences such as preeclampsia and cesarean section. The report
further states that vitamin D plays a significant role during pregnancy which includes:
preeclampsia and cesarean section (Dawodu et al., 2013).
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In a review paper published by Ioannou et al. (2012), it was published there
is lack of data when it comes to vitamin D supplement and its effect during
pregnancy. In this review it had listed 7 records in relation to the topic, within which 4
studies reported the clinical results, but it was not sufficient for the evaluation of the
effects of Vitamin D and its supplementation during the gestation period.
In the year Sørensen et al. (2012) started the 6 year randomized double-blind
and placebo-control trial of Vitamin D supplementation on pregnant women to
understand the clinical safety outcomes which was approved by Investigational Drug
Application with respect to FDA (#66,346). In our hypothesis it was observed that
4000 IU per day vitamin D3 was more effective than 2000 IU per day and the standard
dose of 400 UI per day which had gained circulating 25 (OH) D level of 80nmoL/L or
32ng/Ml in pregnant women irrespective of the race throughout the gestation period
as well as during delivery without raising clinical safety concern.
On the basis of the research observed over the years it was found minimal
value was 80 nmol/L with respect to 25(OH)D levels which had suppressed secondary
hyperthyroidism, the bone density and absorption of calcium in the intestine.
4. METHODOLOGY
Trial design and participants
The following trial was maintained as controlled, double-blind and
randomized study of the supplementation of Vitamin D with 400, 200 and 400 IU was
given to the pregnant Indian women. All the studies were processed in primary
healthcare units and the participants were pregnant expectant Indian mothers who
were at clinics and later on shifted to Max hospital for delivery. Eligible patients who
consented were enrolled in the study. The subject’s eligibility criteria were based on
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the following basis: i) the expectant mothers were to receive delivery and prenatal
care at Al Shaheen Paramedical College & Hospital, mashrakii) the mothers who
were expecting singleton pregnancy iii) the mothers were at gestation period of 12th to
16th week, since their last menstrual cycle or period and by ultrasonography. There
was an exclusion criterion as well: the mothers who had pre-existing calcium as well
as parathyroid conditions, type 1 diabetes, liver, thyroid disease and kidney disease
which had probable effect to the calcium or the Vitamin D levels were excluded.
Initial visit
A questionnaire was included that mentioned the social, demographic,
pregnancy and status which were to be informed. To calculate the calcium intake and
vitamin D the mothers had to complete a standardized food frequency questionnaire
that was followed in Middle Eastern culture. The pregnant mother’s height and weight
were documented, to understand the body mass index of the woman (BMI) [weight in
kilograms /height in square meters). The maternal blood sample was collected by
puncture and the urinary samples were also collected.
Interventions
Vitamin D supplementation
The Vitamin D supplementation were done by giving Vitamin D tablets of
1600 IU and 3600 Vitamin D3, there was also placebo drug which was similar in taste
and color were manufactured. The subjects were given a supply of vitamin D3 tablets
and that was followed by 1 of the 3 dosage as treatment which was determined by the
process of randomization. There was supply of prenatal vitamins which had 400 IU
vitamin D3 in one tablet, was followed for 90 days.
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