Advertisement

Vitamin D Supplementation During Pregnancy and Bone Status in Children at Birth and at One Year of Age

16:51 EDT 23rd May 2013 | BioPortfolio

Summary

Vitamin D deficiency is frequently reported in pregnant women despite recommendation of daily vitamin D supplementation of 400IU/d. Recent studies have shown that in the absence of sun exposure these doses are seldom able to achieve 25(OH)D optimal serum levels.

We hypothesize that larger doses of vitamin D are needed to be supplemented to all women during pregnancy. We hypothesize that this may have advantageous effects on maternal vitamin D and bone reserve as well on offspring vitamin D and bone status at birth and possible further on.

The aim of the present study is to compare vitamin D and bone status of infants born to mothers supplemented with 400IU/d (present recommendations) and 2000IU/d vitamin D during the third trimester of pregnancy.

Description

This is a prospective randomized controlled study.

120 pregnant women will be recruited at 27 weeks gestation and randomized into two treatment groups; 400IU/d or 2000IU/d vitamin D supplementation from 27 weeks until delivery.

25-hydroxyvitamin D (25OHD), parathyroid hormone (PTH), urinary calcium/creatinine and serum calcium and alkaline phosphatase (ALP) levels will be assessed in mothers at 27 weeks and at delivery.

25OHD, calcium and ALP levels, and urinary calcium/creatinine will be evaluated in offspring at birth and at one year age.

Vitamin D and calcium intake and sun exposure will be evaluated in mothers and offsprings.

Quantitative ultrasound (QUS) measurement of tibia and radius will be performed to newborns and at the age of one year.

Bone status of newborns at birth and at one year age in children will be compared between the 2 groups.

Study Design

Allocation: Randomized, Control: Dose Comparison, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Conditions

Healthy

Intervention

Vitamin D

Location

Schneider Children's Medical Center of Israel
Petah Tikva
Israel
49202

Status

Not yet recruiting

Source

Rabin Medical Center

Results (where available)

View Results

Links

Medical and Biotech [MESH] Definitions

Vitamin K

A lipid cofactor that is required for normal blood clotting. Several forms of vitamin K have been identified: VITAMIN K 1 (phytomenadione) derived from plants, VITAMIN K 2 (menaquinone) from bacteria, and synthetic naphthoquinone provitamins, VITAMIN K 3 (menadione). Vitamin K 3 provitamins, after being alkylated in vivo, exhibit the antifibrinolytic activity of vitamin K. Green leafy vegetables, liver, cheese, butter, and egg yolk are good sources of vitamin K.

Vitamin D Deficiency

A nutritional condition produced by a deficiency of VITAMIN D in the diet, insufficient production of vitamin D in the skin, inadequate absorption of vitamin D from the diet, or abnormal conversion of vitamin D to its bioactive metabolites. It is manifested clinically as RICKETS in children and OSTEOMALACIA in adults. (From Cecil Textbook of Medicine, 19th ed, p1406)

Vitamin K 1

A family of phylloquinones that contains a ring of 2-methyl-1,4-naphthoquinone and an isoprenoid side chain. Members of this group of vitamin K 1 have only one double bond on the proximal isoprene unit. Rich sources of vitamin K 1 include green plants, algae, and photosynthetic bacteria. Vitamin K1 has antihemorrhagic and prothrombogenic activity.

Vitamin E Deficiency

A nutritional condition produced by a deficiency of VITAMIN E in the diet, characterized by posterior column and spinocerebellar tract abnormalities, areflexia, ophthalmoplegia, and disturbances of gait, proprioception, and vibration. In premature infants vitamin E deficiency is associated with hemolytic anemia, thrombocytosis, edema, intraventricular hemorrhage, and increasing risk of retrolental fibroplasia and bronchopulmonary dysplasia. An apparent inborn error of vitamin E metabolism, named familial isolated vitamin E deficiency, has recently been identified. (Cecil Textbook of Medicine, 19th ed, p1181)

Vitamin B 12 Deficiency

A nutritional condition produced by a deficiency of VITAMIN B 12 in the diet, characterized by megaloblastic anemia. Since vitamin B 12 is not present in plants, humans have obtained their supply from animal products, from multivitamin supplements in the form of pills, and as additives to food preparations. A wide variety of neuropsychiatric abnormalities is also seen in vitamin B 12 deficiency and appears to be due to an undefined defect involving myelin synthesis. (From Cecil Textbook of Medicine, 19th ed, p848)

Clinical Trials [ 459 Associated Clinical Trials listed on BioPortfolio]

To Study the Effect of Vitamin E and Vitamin C on Restless Leg Syndrome in Hemodialysis Patients

Oxidative stress has a role in uremic neuropathy and may be involved in RLS of ESRD patients.Vitamin E &Vitamin C are potential antioxidant supplement that are used in hemodialysis patient...

Clinical Approaches to Correcting Vitamin D Inadequacy and Maintaining Adequacy

Vitamin D is available in two forms, vitamin D2 and vitamin D3. It has previously been assumed that these two forms maintain blood vitamin D equally. However, this may not be the case....

Treatment of Vitamin D Insufficiency

The purpose of this study is to answer the following questions: Does vitamin D increase calcium absorption, bone mass and muscle mass and function in women past menopause who have mildly l...

Vitamin D Levels and Vitamin D Education in Geriatric Patients

Vitamin D is important to maintain good health. Although it is found in foods and vitamins, many people still have low vitamin D levels. One purpose of this study is to describe vitamin...

Antenatal Vitamin D3 Dose-finding and Safety Study

This is a preliminary study of oral vitamin D3 supplementation in pregnant and non-pregnant women of reproductive age in Bangladesh. The primary objective of the study is to identify a dos...

PubMed Articles [ 2302 Associated PubMed Articles listed on BioPortfolio]

The Level of Orally Ingested Vitamin C Affected the Expression of Vitamin C Transporters and Vitamin C Accumulation in the Livers of ODS Rats.

We investigated the effects of vitamin C administration on vitamin C-specific transporters in ODS/ShiJcl-od/od rat livers. The vitamin C-specific transporter levels increased in the livers of the rats...

Hip fracture : assessment of fracture risk for treatment. Vitamin K and fracture.

Vitamin K is well known for its role in the synthesis of a number of blood coagulation factors. Vitamin K is also an important factor for bone metabolism via gamma-carboxylation of vitamin K-dependent...

Vitamin D content of food and its contribution to vitamin D status: a brief overview and Australian focus.

There are only a few natural foods that contain nutritionally significant quantities of vitamin D. These include egg yolk, some fatty fish, and in much lower concentrations, meat. The published values...

Bioavailability and Efficacy of Vitamin D(2) from UV-Irradiated Yeast in Growing, Vitamin D-Deficient Rats.

New food sources are needed to bridge the gap between vitamin D intake and recommended intake. We assessed the bioavailability and efficacy of vitamin D in an 8 week dose-response study of bread made...

Broth from canned clams is suitable for use as an excellent source of free vitamin b(12).

Vitamin B(12) was assayed and characterized in the broth of canned clams (boiled plain). The broth contained considerable amounts of vitamin B(12) (2.7-14.1 μg/100 g, 1.3-6.7 μg/can). HPLC and LC/ES...

More From BioPortfolio on "Vitamin D Supplementation During Pregnancy and Bone Status in Children at Birth and at One Year of Age"

Search BioPortfolio: