title: Efficacy and safety of Vitamin D supplementation during pregnancy: A randomized trial of two different levels of dosing on maternal and neonatal Vitamin D outcome.
abstract: BACKGROUND
  Pregnant women represent a typical group susceptible to dietary and mineral deficiencies. This study was sought to assess the efficacy and safety of various doses of 25-hydroxyvitamin D (25[OH]D) supplementation during pregnancy and ratify the inadequacy of the recommended daily allowance for Vitamin D in vulnerable groups.
  
  
  METHODS
  A total of 100 pregnant women were included in this open-label, parallel group, prospective, randomized, and controlled trial. Study subjects were assigned to four treatment groups: Group 1 (n = 26), 1000 IU of Vitamin D daily; Group 2 (n = 21), 30,000 IU of Vitamin D monthly; Group 3 (n = 27), 2000 IU of Vitamin D daily; and Group 4 (n = 26), 60,000 IU Vitamin D monthly. Group 1 and 2 were further analyzed together as Group 1K (1000 IU daily and 30,000 IU monthly), and Group 3 and 4 as Group 2K (2000 IU daily and 60,000 IU monthly). The analysis was done on an intention to treat basis.
  
  
  RESULTS
  A total of 87 patients completed the study; 21 in Group 1, 25 in Group 2, 18 in Group 3, and 23 in Group 4. The levels of 25(OH)D at baseline ranged from 1.3 to 58.0 with a mean of 24.2 ± 15.1 ng/ml. Postsupplementation, 25(OH)D levels ranged from 11.5 to 70.3 with a mean of 40.2 ± 12.2 ng/ml. The postsupplementation levels of 25(OH)D were higher in Group 2K (42.86 ± 12.83) than in Group 1K (36.96 ± 10.56) with P value of 0.023.
  
  
  CONCLUSIONS
  We concluded that Vitamin D supplementation with 2000 IU/day or 60,000 IU/month is very effective and safe in achieving Vitamin D sufficiency in pregnant women.
authors.affiliation: Division of Internal Medicine and Endocrinology, Government Medical College, Srinagar, Jammu and Kashmir, India.
authors.forename: Shahnaz Ahmad
authors.initials: SA
authors.lastname: Mir
authors.affiliation: Department of Endocrinology and Metabolism, Sheri-i-Kashmir Institute of Medical Sciences, Srinagar, Jammu and Kashmir, India.
authors.forename: Shariq Rashid
authors.initials: SR
authors.lastname: Masoodi
authors.affiliation: Department of Gynaecology and Obstetrics, Government Lal Ded Hospital, Srinagar, Jammu and Kashmir, India.
authors.forename: Shafia
authors.initials: S
authors.lastname: Shafi
authors.affiliation: Department of Biochemistry, University of Kashmir, Srinagar, Jammu and Kashmir, India.
authors.forename: Iqra
authors.initials: I
authors.lastname: Hameed
authors.affiliation: Department of Endocrinology and Metabolism, Sheri-i-Kashmir Institute of Medical Sciences, Srinagar, Jammu and Kashmir, India.
authors.forename: Maqsood Ahmad
authors.initials: MA
authors.lastname: Dar
authors.affiliation: Department of Endocrinology and Metabolism, Sheri-i-Kashmir Institute of Medical Sciences, Srinagar, Jammu and Kashmir, India.
authors.forename: Mir Iftikhar
authors.initials: MI
authors.lastname: Bashir
authors.affiliation: Department of Endocrinology and Metabolism, Sheri-i-Kashmir Institute of Medical Sciences, Srinagar, Jammu and Kashmir, India.
authors.forename: Arshad Iqbal
authors.initials: AI
authors.lastname: Wani
authors.affiliation: Department of Immunology and Molecular Medicine, Sheri-i-Kashmir Institute of Medical Sciences, Srinagar, Jammu and Kashmir, India.
authors.forename: Zaffar Amin
authors.initials: ZA
authors.lastname: Shah
authors.affiliation: Department of Gynaecology and Obstetrics, Sheri-i-Kashmir Institute of Medical Sciences, Srinagar, Jammu and Kashmir, India.
authors.forename: Shameema
authors.initials: S
authors.lastname: Parveen
authors.affiliation: Department of Endocrinology and Metabolism, Sheri-i-Kashmir Institute of Medical Sciences, Srinagar, Jammu and Kashmir, India.
authors.forename: Abdul Hamid
authors.initials: AH
authors.lastname: Zargar
authors.affiliation: Division of Internal Medicine and Endocrinology, Government Medical College, Srinagar, Jammu and Kashmir, India.
authors.forename: Parviz Ahmad
authors.initials: PA
authors.lastname: Shah
keywords: Dose; Vitamin D; efficacy; pregnancy