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 1 Flow of participants through study
© Copyright Policy - open-access
Related In: Results  -  Collection

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

fig1: Fig 1 Flow of participants through study

Mentions: Figure 1 shows the flow of participants through the study. The addresses of 138 of 2079 (6.6%) infants allocated to treatment were not found and the parents could not be contacted as the poorest families lacked mobile phones. A further 413 (19.9%) infants were lost to follow-up, primarily because many from outlying rural areas returned to their homes after obtaining healthcare despite saying at recruitment that they intended to stay in the area for at least six months. Two hundred and seven (10%) infants were additionally lost to follow-up for anthropometric data, but morbidity and visits to clinics or hospital were collected by weekly mobile phone calls so that data were available for the primary outcome for 72% of those initially randomised but anthropometric data for only 62%. Losses to follow-up were biased to poorer families; those lost to morbidity follow-up were more likely to be from smaller and nuclear families, to have less well educated parents, and to be from the lowest quintiles for socioeconomic status (see web extra table 1). Similar results were found for those missing anthropometric data at follow-up. A larger number had missing results for plasma calcidiol levels owing to the late start of blood collection and refusals; factors associated with missing values were low quintile for socioeconomic status, low maternal education, low paternal education, and nuclear family type.


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 1 Flow of participants through study
© Copyright Policy - open-access
Related In: Results  -  Collection

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

fig1: Fig 1 Flow of participants through study
Mentions: Figure 1 shows the flow of participants through the study. The addresses of 138 of 2079 (6.6%) infants allocated to treatment were not found and the parents could not be contacted as the poorest families lacked mobile phones. A further 413 (19.9%) infants were lost to follow-up, primarily because many from outlying rural areas returned to their homes after obtaining healthcare despite saying at recruitment that they intended to stay in the area for at least six months. Two hundred and seven (10%) infants were additionally lost to follow-up for anthropometric data, but morbidity and visits to clinics or hospital were collected by weekly mobile phone calls so that data were available for the primary outcome for 72% of those initially randomised but anthropometric data for only 62%. Losses to follow-up were biased to poorer families; those lost to morbidity follow-up were more likely to be from smaller and nuclear families, to have less well educated parents, and to be from the lowest quintiles for socioeconomic status (see web extra table 1). Similar results were found for those missing anthropometric data at follow-up. A larger number had missing results for plasma calcidiol levels owing to the late start of blood collection and refusals; factors associated with missing values were low quintile for socioeconomic status, low maternal education, low paternal education, and nuclear family type.

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