PREDIN: Pregnancy and Vitamin D Intervention Study - A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 105
- 试验地点
- 1
- 主要终点
- 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
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Care Provider)
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •pregnant women in gestational week <15
排除标准
- •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
研究组 & 干预措施
Vitamin D Supplementation 20 µg/day
Dietary supplements containing 20 µg of vitamin D per day will be provided to study subjects.
干预措施: Vitamin D Supplementation 20 µg/day (Dietary Supplement)
Vitamin D Supplementation 40 µg/day
Dietary supplements containing 40 µg of vitamin D per day will be provided to study subjects.
干预措施: Vitamin D Supplementation 40 µg/day (Dietary Supplement)
Usual Antenatal Care
Women randomized to usual antenatal care will receive advise about vitamin D supplementation according to usual antenatal care routines.
干预措施: Usual Antenatal Care (Other)
结局指标
主要结局
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
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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
次要结局
- C-reactive protein(From inclusion in first trimester to follow-up in third trimester, up to 9 months)
- Interleukines(From inclusion in first trimester to follow-up in third trimester, up to 9 months)
- Cytokines(From inclusion in first trimester to follow-up in third trimester, up to 9 months)
- Cortisol(From inclusion in first trimester to follow-up in third trimester, up to 9 months)
- Gene variant related to vitamin D metabolism(At inclusion in first trimester of pregnancy)
- Ferritin(From inclusion in first trimester to follow-up in third trimester, up to 9 months)
- Hemoglobin(From inclusion in first trimester to follow-up in third trimester, up to 9 months)
- Metabolomics(From inclusion in first trimester to follow-up in third trimester, up to 9 months)
- Parathyroid hormone(From inclusion in first trimester to follow-up in third trimester, up to 9 months)
- Estrogen(From inclusion in first trimester to follow-up in third trimester, up to 9 months)
- Progesterone(From inclusion in first trimester to follow-up in third trimester, up to 9 months)
- 24,25-Dihydroxyvitamin D(From inclusion in first trimester to follow-up in third trimester, up to 9 months)
- Dietary intake(At inclusion in first trimester and at follow-up in third trimester, up to 9 months)
- Body weight development(From inclusion in first trimester to follow-up in third trimester, up to 9 months)
- Incidence of pregnancy-induced hypertension(Up to delivery)
- Incidence of pre-eclampsia(Up to delivery)
- Incidence of gestational diabetes(Up to delivery (up to 9 months))
- Incidence of preterm delivery(Up to 37 completed weeks)
- Incidence of small for gestational age (SGA)(At delivery)
- Incidence of large for gestational age (LGA)(At delivery)
- Incidence of Intrauterine growth restriction (IUGR)(At delivery)
- Apgar scores(At 1, 5 and 10 minutes after delivery)
- Incidence of Caesarean sections(At delivery)
- Incidence of miscarriage(During the first 21+6 weeks of pregnancy)
- Incidence of Intrauterine fetal demise (IUFD)(Any time during pregnancy after pregnancy week 22+0 (up to 9 months))