Impact evaluation of the efficacy of different doses of vitamin D supplementation during pregnancy on pregnancy and birth outcomes: a randomised, controlled, dose comparison trial in Pakistan.

BACKGROUND: Vitamin D deficiency during pregnancy is a public health problem in Pakistan and is prevalent among most women of reproductive age in the country. Vitamin D supplementation during pregnancy is suggested to prevent adverse pregnancy outcomes and vitamin D deficiency in both the mother and her newborn. METHODS: We conducted a double-blinded, randomised controlled trial in Karachi, Pakistan to evaluate the effect of different doses of vitamin D supplementation during pregnancy on biochemical markers (serum 25(OH)D, calcium, phosphorus and alkaline phosphatase) in women and neonates, and on pregnancy and birth outcomes (gestational diabetes, pre-eclampsia, low birth weight, preterm births and stillbirths). RESULTS: Pregnant women (N=350) in their first trimester were recruited and randomised to three treatment groups of vitamin D supplementation: 4000 IU/day (group A, n=120), 2000 IU/day (group B, n=115) or 400 IU/day (group C, n=115). Women and their newborn in group A had the lowest vitamin D deficiency at endline (endline: 75.9%; neonatal: 64.9%), followed by group B (endline: 84.9%; neonatal: 73.7%) and then the control group (endline: 90.2%; neonatal: 91.8%). Vitamin D deficiency was significantly lower in group A than in group C (p=0.006) among women at endline and lower in both groups A and B than in the control group (p=0.001) in neonates. Within groups, serum 25(OH)D was significantly higher between baseline and endline in group A and between maternal baseline and neonatal levels in groups A and B. Participant serum 25(OH)D levels at the end of the trial were positively correlated with those in intervention group A (4000 IU/day) (ß=4.16, 95% CI 1.6 to 6.7, p=0.002), with food group consumption (ß=0.95, 95% CI 0.01 to 1.89, p=0.047) and with baseline levels of serum 25(OH)D (ß=0.43, 95% CI 0.29 to 0.58, p<0.0001). CONCLUSION: The evidence provided in our study indicates that vitamin D supplementation of 4000 IU/day was more effective in reducing vitamin D deficiency among pregnant women and in improving serum 25(OH)D levels in mothers and their neonates compared with 2000 IU/day and 400 IU/day. Trial registration number NCT02215213.

Improvement in Neuropathy Specific Quality of Life in Patients with Diabetes after Vitamin D Supplementation.

OBJECTIVE: To assess the effect of vitamin D supplementation on neuropathy specific quality of life (NeuroQoL) in patients with painful diabetic neuropathy. METHODS: This prospective, open label study was conducted between June 2012 and April 2013. Patients with symptomatic diabetic neuropathy were given a single dose of 600,000 IU intramuscular vitamin D, and NeuroQol was assessed at baseline and at five follow-up visits every 4 weeks. RESULTS: Of 143 participants, 41.3% were vitamin D deficient (vitamin D < 20 ng/ml). Treatment with vitamin D resulted in a significant increase in 25(OH)D (P < 0.0001) and a significant improvement in the NeuroQoL subscale score for emotional distress (P = 0.04), with no significant change in the other NeuroQoL domains of painful symptoms and paresthesia, loss of temperature and touch sensation, unsteadiness, limitation in daily activities, and interpersonal problems. There was a significant reduction in patient perception about foot problems on QoL of "quite a lot" (P < 0.05) and "very much" (P < 0.0001) with a significant reduction in the baseline response of having a "poor" QoL from 5.2% to 0.7% (P < 0.0001) and an increase in the response of an "excellent QoL" from 1.5% to 7.4% (P < 0.0001). CONCLUSION: Vitamin D is effective in improving quality of life in patients with painful diabetic neuropathy.

Vitamin D for the treatment of painful diabetic neuropathy.

OBJECTIVE: To assess the effect of high-dose vitamin D in patients with painful diabetic neuropathy. METHODS: A single intramuscular dose of 600 000 IU vitamin D was administered, and the effects on metabolic parameters and neuropathic pain assessed over 20 weeks. RESULTS: 143 participants with predominantly type 2 diabetes, aged 52.31±11.48 years, with a Douleur Neuropathique 4 (DN4) score (3.0±1.8), total McGill pain score (21.2±14.9), and Short Form McGill Pain Questionnaire (SFMPQ) score (2.1±0.9), were enrolled. The baseline 25-hydroxyvitamin D (25(OH)D) level was 31.7±23.3 ng/mL and 58 (40.5%) patients showed evidence of vitamin D deficiency (25(OH)D<20 ng/mL). Intramuscular administration of vitamin D resulted in a significant increase in 25(OH)D (46.2±10.2 ng/mL, p<0.0001) and a reduction in positive symptoms on the DN4 (p<0.0001), total pain score (p<0.0001), and SFMPQ (p<0.0001). CONCLUSIONS: Treatment with a single intramuscular dose of 600 000 IU of vitamin D in patients with painful diabetic neuropathy is associated with a significant decrease in the symptoms of painful diabetic neuropathy. TRIAL REGISTRATION NUMBER: BIDE-12/2014.