Oral Vitamin D supplementation as a safe, affordable treatment for profound vitamin D deficiency in pregnancy
Medical Research Council
CBCI Society for Medical Education
We aim to address to the extent supplementation with 2000 IU/day vitamin D3 corrects deficiency in pregnant women in India, which has not previously been tested. We propose this is linked to lack of awareness amongst stakeholders of the benefits of offering higher vitamin D doses than current Indian RDA (<500 IU/day). Aim 1: In a pilot study determine whether the highest acceptable level of vitamin D supplementation approved by the Govt. of India leads to repletion of pregnant women at St. John's Medical College Hospital, Bangalore. Study design: Pregnant women (n=186-200) will receive 2000 IU vitamin D/day from end of the 1st trimester to term. Vitamin D status will be monitored in pregnancy [T1, T2, T3] in serum (5ml), and in the baby by sensitive LC-MS. Samples: Cord blood from a subset of babies will be sued to study the impact of maternal intervention on innate secreted cytokine responses as a measure of newborn immunity, powered on our immune data from the USA VDAART trial. Aim 2: Form a cross India network comprising scientists, clinicians, health care workers, policy makers to discuss realizing the known benefits of vitamin D supplementation in pregnancy. We will invite international experts to a workshop to discuss heterogeneity globally and within India on vitamin D dose and supplementation regimens; a meta-analysis of vitamin D studies in India in the context of global vitamin D trial outcomes and a projected review with the potential to influence national strategy are planned. Days 1-2: A closed 2-day workshop discussing whether vitamin D dose and timing regimen is the same across different clinical (e.g. skeletal vs non-skeletal), biochemical and immune outcomes. We anticipate strong representation of vitamin D interests across India. Day 3: This session will be open to all interested parties across India to ensure knowledge dissemination and transfer, and to help understand the depth of interest in vitamin D and existing concerns in India
6.1 Pharmaceuticals / Research Grant