Limits...
Effect of weekly vitamin D supplements on mortality, morbidity, and growth of low birthweight term infants in India up to age 6 months: randomised controlled trial.

Kumar GT, Sachdev HS, Chellani H, Rehman AM, Singh V, Arora H, Filteau S - BMJ (2011)

Bottom Line: Main secondary outcome was growth.Infants were visited weekly at home for observed supplementation and were brought to the clinic monthly for clinical examination and anthropometric measurements.A weekly dose of vitamin D resulted in better vitamin D status and benefited the classic vitamin D function of bone growth but did not decrease the incidence of severe morbidity or death among young low birthweight infants.

View Article: PubMed Central - PubMed

Affiliation: Institute of Home Economics, Delhi University, F-4 Haus Khas Enclave, New Delhi 110016, India. geetatrilokkumar@gmail.com

ABSTRACT

Objective: To investigate whether vitamin D supplementation can decrease the mortality and morbidity of low birthweight infants in low income countries.

Design: Randomised controlled trial.

Setting: Large government hospital in New Delhi, India.

Participants: 2079 low birthweight infants born at term (>37 weeks' gestation).

Main outcome measures: Primary outcome was admission to hospital or death during the first six months of life. Main secondary outcome was growth.

Interventions: Weekly vitamin D supplements for six months at a dose of one recommended nutrient intake per day (35 µg/week). Infants were visited weekly at home for observed supplementation and were brought to the clinic monthly for clinical examination and anthropometric measurements.

Results: Between group differences were not significant for death or hospital admissions (92 among 1039 infants in the vitamin D group v 99 among 1040 infants in the placebo group; adjusted rate ratio 0.93, 95% confidence interval 0.68 to 1.29; P = 0.68), or referral to the outpatient clinic for moderate morbidity. Vitamin D supplementation resulted in better vitamin D status as assessed by plasma calcidiol levels at six months. In adjusted analyses, vitamin D treatment significantly increased standard deviation (z) scores at six months for weight, length, and arm circumference and decreased the proportion of children with stunted growth (length for age z score ≤ 2) or with arm circumference z scores of 2 or less.

Conclusion: A weekly dose of vitamin D resulted in better vitamin D status and benefited the classic vitamin D function of bone growth but did not decrease the incidence of severe morbidity or death among young low birthweight infants. Trial registration ClinicalTrials.gov NCT00415402.

Show MeSH

Related in: MedlinePlus

Fig 2 Kaplan-Meier plot of time to admission to hospital or death of infants receiving vitamin D supplementation or placebo
© Copyright Policy - open-access
Related In: Results  -  Collection

License 1 - License 2
getmorefigures.php?uid=PMC3104477&req=5

fig2: Fig 2 Kaplan-Meier plot of time to admission to hospital or death of infants receiving vitamin D supplementation or placebo

Mentions: Figure 2 shows the cumulative incidence of hospital admission or death. Twenty deaths occurred in the vitamin D arm and 19 in the placebo arm but 15 were before any supplementation (fig 1). Causes of death for those dying after receiving supplements were based on hospital records (n=8), or on verbal autopsy for those dying at home (n=16): pneumonia (n=7), septicaemia (n=6), diarrhoea (n=4), fever (n=2), not feeding (n=1), and unknown (n=4). Causes of death were known for only two (one septicaemia and one pneumonia) of the 15 infants who died before supplementation. Rates of death and admission to hospital did not differ between groups in either unadjusted or adjusted analyses (table 3). Vitamin D had no significant effects on mortality alone or on any severe morbidity in either unadjusted or adjusted analyses. Similar effect estimates were obtained when the analyses were repeated excluding the 153 children who never received a dose of vitamin D or placebo (see web extra table 2). For the binary analysis of any hospital admission or death, the unadjusted odds ratio was 0.92 (95% confidence interval 0.67 to 1.26; P=0.59) and the odds ratio adjusted for sex, quintile of socioeconomic status, family type, and maternal education was 0.91 (95% confidence interval 0.66 to 1.26; P=0.57).


Effect of weekly vitamin D supplements on mortality, morbidity, and growth of low birthweight term infants in India up to age 6 months: randomised controlled trial.

Kumar GT, Sachdev HS, Chellani H, Rehman AM, Singh V, Arora H, Filteau S - BMJ (2011)

Fig 2 Kaplan-Meier plot of time to admission to hospital or death of infants receiving vitamin D supplementation or placebo
© Copyright Policy - open-access
Related In: Results  -  Collection

License 1 - License 2
Show All Figures
getmorefigures.php?uid=PMC3104477&req=5

fig2: Fig 2 Kaplan-Meier plot of time to admission to hospital or death of infants receiving vitamin D supplementation or placebo
Mentions: Figure 2 shows the cumulative incidence of hospital admission or death. Twenty deaths occurred in the vitamin D arm and 19 in the placebo arm but 15 were before any supplementation (fig 1). Causes of death for those dying after receiving supplements were based on hospital records (n=8), or on verbal autopsy for those dying at home (n=16): pneumonia (n=7), septicaemia (n=6), diarrhoea (n=4), fever (n=2), not feeding (n=1), and unknown (n=4). Causes of death were known for only two (one septicaemia and one pneumonia) of the 15 infants who died before supplementation. Rates of death and admission to hospital did not differ between groups in either unadjusted or adjusted analyses (table 3). Vitamin D had no significant effects on mortality alone or on any severe morbidity in either unadjusted or adjusted analyses. Similar effect estimates were obtained when the analyses were repeated excluding the 153 children who never received a dose of vitamin D or placebo (see web extra table 2). For the binary analysis of any hospital admission or death, the unadjusted odds ratio was 0.92 (95% confidence interval 0.67 to 1.26; P=0.59) and the odds ratio adjusted for sex, quintile of socioeconomic status, family type, and maternal education was 0.91 (95% confidence interval 0.66 to 1.26; P=0.57).

Bottom Line: Main secondary outcome was growth.Infants were visited weekly at home for observed supplementation and were brought to the clinic monthly for clinical examination and anthropometric measurements.A weekly dose of vitamin D resulted in better vitamin D status and benefited the classic vitamin D function of bone growth but did not decrease the incidence of severe morbidity or death among young low birthweight infants.

View Article: PubMed Central - PubMed

Affiliation: Institute of Home Economics, Delhi University, F-4 Haus Khas Enclave, New Delhi 110016, India. geetatrilokkumar@gmail.com

ABSTRACT

Objective: To investigate whether vitamin D supplementation can decrease the mortality and morbidity of low birthweight infants in low income countries.

Design: Randomised controlled trial.

Setting: Large government hospital in New Delhi, India.

Participants: 2079 low birthweight infants born at term (>37 weeks' gestation).

Main outcome measures: Primary outcome was admission to hospital or death during the first six months of life. Main secondary outcome was growth.

Interventions: Weekly vitamin D supplements for six months at a dose of one recommended nutrient intake per day (35 µg/week). Infants were visited weekly at home for observed supplementation and were brought to the clinic monthly for clinical examination and anthropometric measurements.

Results: Between group differences were not significant for death or hospital admissions (92 among 1039 infants in the vitamin D group v 99 among 1040 infants in the placebo group; adjusted rate ratio 0.93, 95% confidence interval 0.68 to 1.29; P = 0.68), or referral to the outpatient clinic for moderate morbidity. Vitamin D supplementation resulted in better vitamin D status as assessed by plasma calcidiol levels at six months. In adjusted analyses, vitamin D treatment significantly increased standard deviation (z) scores at six months for weight, length, and arm circumference and decreased the proportion of children with stunted growth (length for age z score ≤ 2) or with arm circumference z scores of 2 or less.

Conclusion: A weekly dose of vitamin D resulted in better vitamin D status and benefited the classic vitamin D function of bone growth but did not decrease the incidence of severe morbidity or death among young low birthweight infants. Trial registration ClinicalTrials.gov NCT00415402.

Show MeSH
Related in: MedlinePlus