Dataset Information

Impact of supplementation with milk-cereal mix during 6-12 months of age on growth at 12 months: a 3-arm randomized controlled trial in Delhi, India.

ABSTRACT:

Background

A large proportion of infants in low- and middle-income countries are stunted. These infants are often fed complementary foods that are low-quality, primarily in terms of protein and micronutrients.

Objectives

We aimed to test 2 milk-cereal mixes supplemented with modest and high amounts of protein during 6-12 mo of age, compared with no supplementation, for their effect on length-for-age z score (LAZ) at 12 mo of age.

Methods

Eligible infants (6 mo plus ≤29 d) were randomly assigned to either of the 2 interventions (modest- and high-protein) or a no supplement group. The milk-cereal mixes provided ∼125 kcal, 30%-45% energy from fats, and 80%-100% RDA of multiple micronutrients (MMN). The modest-protein group received 2.5 g protein [protein energy ratio (PER): 8%; 0.75 g from milk source] and the high-protein group received 5.6 g protein (PER: 18%, 1.68 g from milk source). One packet was given daily for 180 d. Counseling on continued breastfeeding and optimal infant-care practices was provided to all.

Results

We enrolled 1548 infants (high-protein: n = 512; modest-protein: n = 519; and no supplement: n = 517). Compared with the no supplement group, there was an improvement in LAZ [adjusted mean difference (MD): 0.08; 95% CI: 0.01, 0.15], weight-for-age z score (MD: 0.12; 95% CI: 0.06, 0.19), weight-for-length z score (MD: 0.11; 95% CI: 0.02, 0.19), and midupper arm circumference z score (MD: 0.10; 95% CI: 0.02, 0.18) in the high-protein group at 12 mo of age. No significant differences for these anthropometric indicators were noted between the modest-protein and no supplement groups or between the high- and modest-protein groups.

Conclusions

Cereal mixes with higher amounts of milk-based protein and MMN may lead to improvement in linear growth and other anthropometric indexes in infants, compared with no supplementation.This trial was registered at ctri.nic.in as CTRI/2018/04/012932.

SUBMITTER: Taneja S

PROVIDER: S-EPMC8754995 | biostudies-literature | 2022 Jan

REPOSITORIES: biostudies-literature

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Publications

Impact of supplementation with milk-cereal mix during 6-12 months of age on growth at 12 months: a 3-arm randomized controlled trial in Delhi, India.

Taneja Sunita S Upadhyay Ravi P RP Chowdhury Ranadip R Kurpad Anura V AV Bhardwaj Himani H Kumar Tivendra T Dwarkanath Pratibha P Bose Beena B Devi Sarita S Kumar Gunjan G Kaur Baljeet B Bahl Rajiv R Bhandari Nita N

The American journal of clinical nutrition 20220101 1

<h4>Background</h4>A large proportion of infants in low- and middle-income countries are stunted. These infants are often fed complementary foods that are low-quality, primarily in terms of protein and micronutrients.<h4>Objectives</h4>We aimed to test 2 milk-cereal mixes supplemented with modest and high amounts of protein during 6-12 mo of age, compared with no supplementation, for their effect on length-for-age z score (LAZ) at 12 mo of age.<h4>Methods</h4>Eligible infants (6 mo plus ≤29 d) w ...[more]

PMID: 34637505

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Project description:ObjectiveTo test for potential non-specific effects of an additional, early measles, mumps, and rubella (MMR) vaccine at age 5-7 months on risk of infection related hospitalisation before age 12 months.DesignRandomised, double blinded, placebo controlled trial.SettingDenmark, a high income setting with low exposure to MMR.Participants6540 Danish infants aged 5 to 7 months.InterventionsInfants were randomly allocated 1:1 to intramuscular injection with standard titre MMR vaccine (M-M-R VaxPro) or placebo (solvent only).Main outcome measuresHospitalisations for infection, defined as all hospital contacts of infants referred from primary care for hospital evaluation and with an infection diagnosed, analysed as recurrent events, from randomisation to 12 months of age. In secondary analyses implications of censoring for date of subsequent diphtheria, tetanus, pertussis, polio, Haemophilus influenzae type B, and immunisation with pneumococci conjugate vaccine (DTaP-IPV-Hib+PCV), potential effect modification by sex, prematurity (<37 weeks' gestation), season, and age at randomisation were tested, and the secondary outcomes of hospitalisations ≥12 hours and antibiotic use were evaluated.Results6536 infants were included in the intention-to-treat analysis. 3264 infants randomised to MMR vaccine experienced 786 hospitalisations for infection before age 12 months compared with 762 for the 3272 infants randomised to placebo. In the intention-to-treat analysis the rate of hospitalisations for infection did not differ between the MMR vaccine and placebo groups (hazard ratio 1.03, 95% confidence interval 0.91 to 1.18). For infants randomised to MMR vaccine compared with those randomised to placebo, the hazard ratio of hospitalisations for infection with a duration of at least 12 hours was 1.25 (0.88 to 1.77), and for prescriptions of antibiotics was 1.04 (0.88 to 1.23). No significant effect modifications were found by sex, prematurity, age at randomisation, or season. The estimate did not change when censoring at the date infants received DTaP-IPV-Hib+PCV after randomisation (1.02, 0.90 to 1.16).ConclusionFindings of this trial conducted in Denmark, a high income setting, do not support the hypothesis that live attenuated MMR vaccine administered early to infants aged 5-7 months decreases the rate of hospitalisations for non-targeted infection before age 12 months.Trial registrationEU Clinical Trials Registry EudraCT 2016-001901-18 and ClinicalTrials.gov NCT03780179.

Dataset Information

Impact of supplementation with milk-cereal mix during 6-12 months of age on growth at 12 months: a 3-arm randomized controlled trial in Delhi, India.

Background

Objectives

Methods

Results

Conclusions

Publications

Impact of supplementation with milk-cereal mix during 6-12 months of age on growth at 12 months: a 3-arm randomized controlled trial in Delhi, India.

Similar Datasets

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