RecruitingPhase 2ACTRN12610000483055

Randomised placebo controlled study of vitamin D during pregnancy and infancy

Randomised placebo controlled study of vitamin D3 during pregnancy and infancy to determine the vitamin D dose in pregnancy and early life that safely and effectively increases serum vitamin D concentration in infants.


Sponsor

University of Auckland

Enrollment

260 participants

Start Date

Apr 1, 2010

Study Type

Interventional

Conditions

Summary

In New Zealand the Ministry of Health does not currently recommend vitamin D supplementation in pregnancy or infancy. Vitamin D deficiency is common in New Zealand as are poor health outcomes associated with vitamin D deficiency. Aim: To determine the vitamin D dose in pregnancy and early life that safely and effectively increases serum 25-hydroxy vitamin D (25[OH]D) concentration in infants. Design: A double blind randomised placebo controlled trial of 2 different daily vitamin D doses in pregnancy and early infancy. Outcomes: (1) Provide advice to the Ministry of Health as to the most appropriate vitamin D dose in pregnancy and infancy for New Zealand, and (2) to determine the most appropriate vitamin D dose in pregnancy and infancy for a proposed randomised clinical trial of vitamin D in pregnancy and infancy aimed at reducing infectious diseases in early childhood, and preventing asthma and allergic diseases


Eligibility

Sex: Females

Plain Language Summary

Simplified for easier understanding

This study is testing two different doses of daily vitamin D supplements — given during pregnancy and continued in early infancy — to find the safest and most effective amount to prevent vitamin D deficiency in New Zealand babies. Vitamin D deficiency is common in New Zealand and can affect bone health, immune function, and the risk of infections and allergies in young children. The goal is to provide recommendations to the Ministry of Health about whether pregnant women and infants should receive vitamin D supplements. You may be eligible if: - You are pregnant and planning to deliver at Middlemore Hospital - You are either a public patient or your midwife (lead maternity caregiver) is part of South Auckland Maternity Care Limited (SAMCL) You may NOT be eligible if: - You are already taking more than 200 IU of vitamin D per day - You have a history of kidney stones or high calcium levels in your blood - You have a serious complication of pregnancy at the time of enrolment Talk to your doctor about whether this trial might be right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

1. Enrolled mothers will be randomised to receive either placebo or 1000 IU/day or 2000 IU/day of vitamin D3. 2. The infants of these mothers will be randomised to receive placebo, if their mother wa

1. Enrolled mothers will be randomised to receive either placebo or 1000 IU/day or 2000 IU/day of vitamin D3. 2. The infants of these mothers will be randomised to receive placebo, if their mother was randomised to placebo, 400 IU/day (if mother’s dose was 1000 IU/day) or 800 IU/day of vitamin D3 (if mother’s dose was 2000 IU/day). Vitamin D supplementation and placebo will be an oral liquid medicine Each enrolled pregnant woman will receive the study medicine from enrollment at apporximately 28 gestation until childbirth. Each enrolled infant will receive the study medicine from birth until 6 months of age.


Locations(1)

New Zealand

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ACTRN12610000483055