Rasmussen 2009.
| Trial name or title | Effects of vitamin D supplement before and during and after pregnancy on complications, birthweight and bone mineral density during lactation. |
| Methods | Double‐blind, randomised, placebo‐controlled trial. |
| Participants | 400 apparently healthy women 30 to 35 years of age, all with concentrations of P‐25‐hydroxyvitamin D‐ lower than 50 nmol/L. All women included attempts to get pregnant. Visits take place at Clinic of Osteoporosis, Department of Endocrinology, at Aarhus University Hospital, Aarhus, Denmark. Women with infertility, an intake of 400 IU or more vitamin D/day, cancer, history of alcohol or drug abuse, calcium metabolic disturbances or spontaneous abortion within last 6 months will be excluded. |
| Interventions | Participants will be randomly assigned to 1 of 3 groups: group 1: will receive 35 mcg per day cholecalciferol; group 2: will receive 70 mcg per day cholecalciferol; group 3: will receive placebo. All women will receive 2 tablets daily from baseline until 16 weeks after delivery. Intervention with cholecalciferol or placebo starts before pregnancy is achieved and continues until 4 months after the women has given birth. |
| Outcomes | Primary: Infant: birthweight. Maternal: none. Secondary: Infant: weight, crown‐heel length and head circumference, and infections within 16 weeks after birth. Concentration of 25‐hydroxyvitamin D in umbilical cord and venous sample 16 weeks after birth. Maternal: postpartum effects of vitamin D supplement on maternal bone mineral density, concentration of 25‐hydroxyvitamin D in mothers milk, incidence of pre‐eclampsia and abortions. |
| Starting date | Date of start: 12/2009. Status: recruiting participants. Estimated study completion date: December 2011. |
| Contact information | Gitte Bloch Rasmussen, MD Department of Endocrinology, Aarhus University Hospital University of Aarhus Tel: +45 89 4976 81 Email: gittebr@ki.au.dk |
| Notes | Sponsor: University of Aarhus, Denmark. |
BMI: body mass index DRI: dietary references intakes GDM: gestational diabetes mellitus HTN: hypertension IU: international units LMP: last menstrual period mcg: microgram PA: physical activity PCO: polycystic ovary