PREDIN: Pregnancy and Vitamin D Intervention Study
- Conditions
- Pregnancy ComplicationsVitamin D DeficiencyVitamin D3 Deficiency
- Interventions
- Dietary Supplement: Vitamin D Supplementation 40 µg/dayOther: Usual Antenatal CareDietary Supplement: Vitamin D Supplementation 20 µg/day
- Registration Number
- NCT05329428
- Lead Sponsor
- Göteborg University
- Brief Summary
Vitamin D deficiency is common among certain risk groups in Sweden, and occurs approximately in every tenth pregnant woman.The aim of the randomized double-blind controlled trial Pregnancy vitamin D intervention (PREDIN) is to investigate the dose of vitamin D supplementation required in achieving vitamin D sufficiency (25OHD ≥50 nmol/l) in pregnant women at risk of vitamin D deficiency. In addition, the investigators aim to examine if the overall vitamin D status and vitamin D intake have increased since the expanded vitamin D fortification program was initiated in year 2020.
- Detailed Description
The effect of maternal vitamin D in pregnancy for maternal and offspring health needs to be clarified. In observational studies, the investigators and others show associations between poor maternal vitamin D status in pregnancy and an increased risk of pregnancy complications. Poor maternal vitamin D status is also linked to impaired growth in the first year of life, and potentially also to higher risk of developing obesity in childhood. Risk factors for vitamin D deficiency in Swedish pregnant women are related to lower intake of vitamin D and to less sun exposure.
Since the evidence for positive effects of maternal vitamin D status or intake is limited, vitamin D interventions in pregnancy are warranted to clarify the causal effects of vitamin D in pregnancy and the doses required to achieve sufficient vitamin D status in deficient women. In the first trimester, pregnant women will be screened at a routine visit in the antenatal care for the risk of vitamin D deficiency using a validated questionnaire. Women who are classified as having a high risk of vitamin D deficiency will be randomized to one of three study arms: usual antenatal care, 20 µg vitamin D per day or 40 µg vitamin D per day. The participants will be followed up until delivery. Blood will be collected for analysis of vitamin D status (25OHD) at screening and in the third trimester of pregnancy. Information regarding pregnancy, gestational complication and fetal growth will be retrieved from medical records after delivery. About 500 women will be screened and their vitamin D status and vitamin D intake will be compared to a previous population-based cohort study, to investigate if the status or intake of vitamin D has increased since the expanded food fortification program was introduced.
The study hypothesis is that vitamin D status and/or vitamin D intake is related to risk of developing complications during pregnancy or delivery and that maternal supplementation with vitamin D during pregnancy will be effective in achieving vitamin D sufficiency in pregnant women at risk of vitamin D deficiency. In addition, the investigators hypothesize that the expanded vitamin D food fortification program has increased the vitamin D status and vitamin D intake of pregnant women in Gothenburg since 2013-2014.
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- Female
- Target Recruitment
- 102
- pregnant women in gestational week <15
- multi-fetal pregnancy
- known disorder to the metabolism of vitamin D, calcium or phosphate (e.g. adrenal gland disorders, kidney disease)
- ongoing treatment with vitamin D of ≥10 µg/day
- difficulties understanding the study information
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Vitamin D Supplementation 40 µg/day Vitamin D Supplementation 40 µg/day Dietary supplements containing 40 µg of vitamin D per day will be provided to study subjects. Usual Antenatal Care Usual Antenatal Care Women randomized to usual antenatal care will receive advise about vitamin D supplementation according to usual antenatal care routines. Vitamin D Supplementation 20 µg/day Vitamin D Supplementation 20 µg/day Dietary supplements containing 20 µg of vitamin D per day will be provided to study subjects.
- Primary Outcome Measures
Name Time Method Difference in maternal vitamin D binding proteins between the three groups; intakes of vitamin D supplements 40 µg/day or 20 µg/day or usual antenatal care routines From inclusion in first trimester to follow-up in third trimester, up to 9 months Analyses of vitamin D binding proteins from blood samples drawn in first- and third trimester of pregnancy
Difference in maternal 3-epi-25-Hydroxyvitamin D between the three groups; intakes of vitamin D supplements 40 µg/day or 20 µg/day or usual antenatal care routines From inclusion in first trimester to follow-up in third trimester, up to 9 months Analyses of vitamin D metabolites 3-epi-25-Hydroxyvitamin D3 from blood samples drawn in first- and third trimester of pregnancy
Difference in maternal 1,25-dihydroxyvitamin D between the three groups; intakes of vitamin D supplements 40 µg/day or 20 µg/day or usual antenatal care routines From inclusion in first trimester to follow-up in third trimester, up to 9 months Analyses of 1,25-dihydroxyvitamin D from blood samples drawn in first- and third trimester of pregnancy
Difference in maternal vitamin D status (25OHD) between intake of vitamin D supplements (both 40 µg per day or 20 µg per day) during pregnancy and usual antenatal care routines From inclusion in first trimester to follow-up in third trimester, up to 9 months Analyses of 25OHD (25OHD3 and 25OHD2) from blood samples drawn in first- and third trimester of pregnancy
Difference in maternal vitamin D status (25OHD) between intake of vitamin D supplements containing either 40 µg per day or 20 µg per day during pregnancy From inclusion in first trimester to follow-up in third trimester, up to 9 months Analyses of 25OHD (25OHD3 and 25OHD2) from blood samples drawn in first- and third trimester of pregnancy
- Secondary Outcome Measures
Name Time Method Incidence of gestational diabetes Up to delivery (up to 9 months) Diagnosis of gestational diabetes
C-reactive protein From inclusion in first trimester to follow-up in third trimester, up to 9 months Analyses of inflammation e.g. c-reactive protein
Incidence of small for gestational age (SGA) At delivery SGA born infant
Ferritin From inclusion in first trimester to follow-up in third trimester, up to 9 months Analyses of ferritin
Cytokines From inclusion in first trimester to follow-up in third trimester, up to 9 months Analyses of inflammation e.g. cytokines
Incidence of pre-eclampsia Up to delivery Diagnosis of pre-eclampsia
Hemoglobin From inclusion in first trimester to follow-up in third trimester, up to 9 months Analyses of hemoglobin
Metabolomics From inclusion in first trimester to follow-up in third trimester, up to 9 months Analyses of metabolomics in blood
Parathyroid hormone From inclusion in first trimester to follow-up in third trimester, up to 9 months Analysis of parathyroid hormone in sampled blood at the routine laboratory
Incidence of pregnancy-induced hypertension Up to delivery Diagnosis of pregnancy-induced hypertension
Apgar scores At 1, 5 and 10 minutes after delivery Vitality signs are estimated as Apgar scores at 1, 5 and 10 minutes after birth of the newborn. Apgar stands for Appearance, pulse, grimace, activity and respiration. The maximium score at each time point is 10 scores and a high score indicates high vitality, where as a low score indicates very low vitality.
Gene variant related to vitamin D metabolism At inclusion in first trimester of pregnancy Analyses of gene variants in blood sample drawn at inclusion in first trimester of pregnancy
Dietary intake At inclusion in first trimester and at follow-up in third trimester, up to 9 months Dietary intake of mother during pregnancy assessed by dietary record at two time points
Incidence of preterm delivery Up to 37 completed weeks Delivery before 37 weeks completed weeks of gestation
Incidence of large for gestational age (LGA) At delivery LGA born infant
Incidence of Intrauterine fetal demise (IUFD) Any time during pregnancy after pregnancy week 22+0 (up to 9 months) IUFD
Interleukines From inclusion in first trimester to follow-up in third trimester, up to 9 months Analyses of inflammation e.g. interleukines
Incidence of Intrauterine growth restriction (IUGR) At delivery IUGR
Incidence of Caesarean sections At delivery Delivery by caesarean sections
Cortisol From inclusion in first trimester to follow-up in third trimester, up to 9 months Analyses of cortisol
Estrogen From inclusion in first trimester to follow-up in third trimester, up to 9 months Analyses of estrogen, in sampled blood, at the routine laboratory
Progesterone From inclusion in first trimester to follow-up in third trimester, up to 9 months Analyses of progesterone, in sampled blood, at the routine laboratory
Body weight development From inclusion in first trimester to follow-up in third trimester, up to 9 months Self-reported weight (in kilograms) during pregnancy until delivery.
Incidence of miscarriage During the first 21+6 weeks of pregnancy Miscarriage
Trial Locations
- Locations (1)
Antenatal Care
🇸🇪Gothenburg, Sweden