Nouripour 2016.

Trial name or title	Clinical trial on the evaluation of calcium and vitamin D in the cord serum of neonates, whose mothers were under vitamin D treatment during their pregnancy
Methods	2 groups of 90 pregnant mothers with vitamin D deficiency,were selected and named intervention and control groups. Inclusion criteria: pregnant mothers with vitamin D deficiency; age of 16‐35 years; singleton pregnancy; gestational age of among 8 to 12 weeks which is confirmed by LMP or sonography; BMI lower than 30 at the first prenatal visit; no history of gestational diabetes; not suffering from glycosuria, fasting blood sugar less than 92; no precedent of polyhydramnios; no history of macrosomia (weight of 4 kg) in children; with no history of stillbirth or a baby with malformations; non‐smoking participants. Exclusion criteria: patients with diabetes type 1 or 2; those with hypertension; patients with parathyroid disease and other metabolic diseases; women with untreated thyroid disease and liver or kidney deficiency; patients taking anti‐epileptic drugs and corticosteroids; and women with a particular disease. Also, those who refused consent for participating in this study, were excluded. Intervention group: 8 doses of vitamin D pearls every 2 weeks; each dose contained 50,000 units, plus multi prenatal tablet including 400 units of vitamin D, every day. Control group: only received the multi prenatal tablet, every day. The methods which were used in collecting data were a demographic questionnaire and recording data check‐lists which were filled with laboratory assessments. Additionally, this is a single‐blinded study that include just research groups. In order to collect data, 3 mL of cord blood in related tubes were collected, at the time of childbirth. These were then were transferred to the laboratory of Semnan Amir al‐mo'menin Hospital and the levels of serum 25‐OH vitamin D and calcium were evaluated with England Euroimmun and Semnan Rezatec kits using ELISA method, respectively.
Participants	The population of this study includes all neonates of pregnant women who were aged 16 to 35 years and between 14 to 16 weeks of pregnancy referred to Amiral‐mo'menin Hospital in 1393 for prenatal care
Interventions	Group 1 –offspring of mothers who received injection of 50,000 units of vitamin D, 8 doses every 2 weeks Group 2 – (control group) offspring of mothers who received multi prenatal tab including 400 units of vitamin D every day
Outcomes	Primary outcome measure 25oH vitamin D3 mg/dL Calcium mg/dL
Starting date	21 March 2015
Contact information	Shamsollah Nooripour, Amiralmomenin Hospital, Iran Email: amir.hospital@semums.ac.ir Phone +98 23 3346 0077
Notes	Funding: Vice chancellor for research, Semnan University of Medical Science Declarations of interest among primary researchers: NA