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Maternal vitamin D supplementation during pregnancy and lactation to promote infant growth in Dhaka, Bangladesh (MDIG trial): study protocol for a randomized controlled trial.

Roth DE, Gernand AD, Morris SK, Pezzack B, Islam MM, Dimitris MC, Shanta SS, Zlotkin SH, Willan AR, Ahmed T, Shah PS, Murphy KE, Weksberg R, Choufani S, Shah R, Al Mahmud A - Trials (2015)

Bottom Line: Vitamin D regulates bone mineral metabolism and skeletal development.Generally healthy pregnant women (n = 1300) in the second trimester (17-24 weeks of gestation) are randomized to one of five parallel arms: placebo 4200 IU/wk, 16,800 IU/wk, or 28,000 IU/wk in the prenatal period and placebo in the postpartum period or 28,000 IU/wk in the prenatal period and 28,000 IU/wk in the postpartum period.Household- and clinic-based follow-up of mother-infant pairs is conducted weekly by trained personnel until 26 weeks postpartum and every 3 months thereafter.

View Article: PubMed Central - PubMed

Affiliation: Department of Paediatrics, University of Toronto and the Centre for Global Child Health, Hospital for Sick Children, 686 Bay Street, Toronto, ON, Canada. daniel.roth@sickkids.ca.

ABSTRACT

Background: Vitamin D regulates bone mineral metabolism and skeletal development. Some observational studies have suggested that prenatal vitamin D deficiency increases the risk of adverse pregnancy and/or birth outcomes; however, there is scant evidence from controlled trials, leading the World Health Organization to advise against routine vitamin D supplementation in pregnancy. Importantly, little is known about the effect of maternal vitamin D status on infant linear growth in communities in South Asia where stunting is highly prevalent and maternal-infant vitamin D status is commonly suboptimal.

Methods/design: The Maternal Vitamin D for Infant Growth study is a randomized, placebo-controlled, dose-ranging trial of maternal vitamin D supplementation during pregnancy and lactation in Dhaka, Bangladesh. The primary aims are to estimate (1) the effect of maternal prenatal oral vitamin D3 supplementation (4200 IU/wk, 16,800 IU/wk, or 28,000 IU/wk, administered as weekly doses) versus placebo on infant length at 1 year of age and (2) the effect of maternal postpartum oral vitamin D3 supplementation (28,000 IU/wk) versus placebo on length at 1 year of age among infants born to women who received vitamin D 28,000 IU/wk during pregnancy. Generally healthy pregnant women (n = 1300) in the second trimester (17-24 weeks of gestation) are randomized to one of five parallel arms: placebo 4200 IU/wk, 16,800 IU/wk, or 28,000 IU/wk in the prenatal period and placebo in the postpartum period or 28,000 IU/wk in the prenatal period and 28,000 IU/wk in the postpartum period. Household- and clinic-based follow-up of mother-infant pairs is conducted weekly by trained personnel until 26 weeks postpartum and every 3 months thereafter. The primary trial outcome measure is length for age z-score at 1 year of age. Anthropometric measurements, clinical information, and biological specimens collected at scheduled intervals will enable the assessment of a range of maternal, perinatal, and infant outcomes.

Discussion: The role of vitamin D in maternal and infant health remains unresolved. This trial is expected to contribute unique insights into the effects of improving maternal-infant vitamin D status in a low-income setting where stunting and adverse perinatal outcomes represent significant public health burdens.

Trial registration: ClinicalTrials.gov identifier: NCT01924013. Registered on 13 August 2013.

No MeSH data available.


Maternal Vitamin D for Infant Growth (MDIG) trial flow diagram. The allocated intervention in each group is shown as “prenatal intervention; postpartum intervention”
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Fig1: Maternal Vitamin D for Infant Growth (MDIG) trial flow diagram. The allocated intervention in each group is shown as “prenatal intervention; postpartum intervention”

Mentions: The MDIG trial is a randomized, placebo-controlled, double-blinded, dose-ranging trial with a 1:1 allocation ratio across five parallel groups (Fig. 1). A total of 1300 pregnant women will be randomized, with a target of allocating 260 women in each group (Fig. 1). The primary outcome analysis will be a between-group comparison of mean LAZs at 1 year of age, assuming up to 15 % attrition from each group before this time point. To assess the effect of prenatal vitamin D, we plan to perform five primary between-group analyses, comprising each vitamin D dose versus placebo (three comparisons) and comparisons between adjacent doses (two comparisons). A conservative approach to addressing multiple testing is to partition the α (risk of type I error) among the five comparisons (conventional overall 0.05 divided by 5); thus, each between-group comparison will be tested as a two-sided test with an α of 0.01, assuming 90 % power. With 220 analyzable participants per group (about 85 % of total enrolled), the minimum detectable difference in LAZ will be 0.40 z-score units, which equates to approximately 1.0 cm at 1 year of age based on WHO growth standards. In our preliminary trial, we observed an increase in LAZ of 0.44 at 1 year attributable to prenatal vitamin D supplementation, which corresponded to an increase of 1.1 cm (95 % CI, 0.06–2.0), adjusted for sex [26].Fig. 1


Maternal vitamin D supplementation during pregnancy and lactation to promote infant growth in Dhaka, Bangladesh (MDIG trial): study protocol for a randomized controlled trial.

Roth DE, Gernand AD, Morris SK, Pezzack B, Islam MM, Dimitris MC, Shanta SS, Zlotkin SH, Willan AR, Ahmed T, Shah PS, Murphy KE, Weksberg R, Choufani S, Shah R, Al Mahmud A - Trials (2015)

Maternal Vitamin D for Infant Growth (MDIG) trial flow diagram. The allocated intervention in each group is shown as “prenatal intervention; postpartum intervention”
© Copyright Policy - open-access
Related In: Results  -  Collection

License 1 - License 2
Show All Figures
getmorefigures.php?uid=PMC4499946&req=5

Fig1: Maternal Vitamin D for Infant Growth (MDIG) trial flow diagram. The allocated intervention in each group is shown as “prenatal intervention; postpartum intervention”
Mentions: The MDIG trial is a randomized, placebo-controlled, double-blinded, dose-ranging trial with a 1:1 allocation ratio across five parallel groups (Fig. 1). A total of 1300 pregnant women will be randomized, with a target of allocating 260 women in each group (Fig. 1). The primary outcome analysis will be a between-group comparison of mean LAZs at 1 year of age, assuming up to 15 % attrition from each group before this time point. To assess the effect of prenatal vitamin D, we plan to perform five primary between-group analyses, comprising each vitamin D dose versus placebo (three comparisons) and comparisons between adjacent doses (two comparisons). A conservative approach to addressing multiple testing is to partition the α (risk of type I error) among the five comparisons (conventional overall 0.05 divided by 5); thus, each between-group comparison will be tested as a two-sided test with an α of 0.01, assuming 90 % power. With 220 analyzable participants per group (about 85 % of total enrolled), the minimum detectable difference in LAZ will be 0.40 z-score units, which equates to approximately 1.0 cm at 1 year of age based on WHO growth standards. In our preliminary trial, we observed an increase in LAZ of 0.44 at 1 year attributable to prenatal vitamin D supplementation, which corresponded to an increase of 1.1 cm (95 % CI, 0.06–2.0), adjusted for sex [26].Fig. 1

Bottom Line: Vitamin D regulates bone mineral metabolism and skeletal development.Generally healthy pregnant women (n = 1300) in the second trimester (17-24 weeks of gestation) are randomized to one of five parallel arms: placebo 4200 IU/wk, 16,800 IU/wk, or 28,000 IU/wk in the prenatal period and placebo in the postpartum period or 28,000 IU/wk in the prenatal period and 28,000 IU/wk in the postpartum period.Household- and clinic-based follow-up of mother-infant pairs is conducted weekly by trained personnel until 26 weeks postpartum and every 3 months thereafter.

View Article: PubMed Central - PubMed

Affiliation: Department of Paediatrics, University of Toronto and the Centre for Global Child Health, Hospital for Sick Children, 686 Bay Street, Toronto, ON, Canada. daniel.roth@sickkids.ca.

ABSTRACT

Background: Vitamin D regulates bone mineral metabolism and skeletal development. Some observational studies have suggested that prenatal vitamin D deficiency increases the risk of adverse pregnancy and/or birth outcomes; however, there is scant evidence from controlled trials, leading the World Health Organization to advise against routine vitamin D supplementation in pregnancy. Importantly, little is known about the effect of maternal vitamin D status on infant linear growth in communities in South Asia where stunting is highly prevalent and maternal-infant vitamin D status is commonly suboptimal.

Methods/design: The Maternal Vitamin D for Infant Growth study is a randomized, placebo-controlled, dose-ranging trial of maternal vitamin D supplementation during pregnancy and lactation in Dhaka, Bangladesh. The primary aims are to estimate (1) the effect of maternal prenatal oral vitamin D3 supplementation (4200 IU/wk, 16,800 IU/wk, or 28,000 IU/wk, administered as weekly doses) versus placebo on infant length at 1 year of age and (2) the effect of maternal postpartum oral vitamin D3 supplementation (28,000 IU/wk) versus placebo on length at 1 year of age among infants born to women who received vitamin D 28,000 IU/wk during pregnancy. Generally healthy pregnant women (n = 1300) in the second trimester (17-24 weeks of gestation) are randomized to one of five parallel arms: placebo 4200 IU/wk, 16,800 IU/wk, or 28,000 IU/wk in the prenatal period and placebo in the postpartum period or 28,000 IU/wk in the prenatal period and 28,000 IU/wk in the postpartum period. Household- and clinic-based follow-up of mother-infant pairs is conducted weekly by trained personnel until 26 weeks postpartum and every 3 months thereafter. The primary trial outcome measure is length for age z-score at 1 year of age. Anthropometric measurements, clinical information, and biological specimens collected at scheduled intervals will enable the assessment of a range of maternal, perinatal, and infant outcomes.

Discussion: The role of vitamin D in maternal and infant health remains unresolved. This trial is expected to contribute unique insights into the effects of improving maternal-infant vitamin D status in a low-income setting where stunting and adverse perinatal outcomes represent significant public health burdens.

Trial registration: ClinicalTrials.gov identifier: NCT01924013. Registered on 13 August 2013.

No MeSH data available.