Effect of maternal multiple micronutrient supplementation on fetal loss and infant death in Indonesia: a double-blind cluster-randomised trial.

BACKGROUND: Maternal nutrient supplementation in developing countries is generally restricted to provision of iron and folic acid (IFA). Change in practice toward supplementation with multiple micronutrients (MMN) has been hindered by little evidence of the effects of MMN on fetal loss and infant death. We assessed the effect of maternal supplementation with MMN, compared with IFA, on fetal loss and infant death in the setting of routine prenatal care services. METHODS: In a double-blind cluster-randomised trial in Lombok, Indonesia, we randomly assigned 262 midwives to distribute IFA (n=15 ,86) or MMN (n=15,804) supplements to 31 290 pregnant women through government prenatal care services that were strengthened by training and community-based advocacy. Women obtained supplements, to be taken daily, every month from enrolment to 90 days post partum. The primary outcome was early infant mortality (deaths until 90 days post partum). Secondary outcomes were neonatal mortality, fetal loss (abortions and stillbirths), and low birthweight. Analysis was by intention to treat. The study is registered as an International Standard Randomised Controlled Trial, number ISRCTN34151616. FINDINGS: Infants of women consuming MMN supplements had an 18% reduction in early infant mortality compared with those of women given IFA (35.5 deaths per 1000 livebirths vs 43 per 1000; relative risk [RR] 0.82, 95% CI 0.70-0.95, p=0.010). Infants whose mothers were undernourished (mid upper arm circumference <23.5 cm) or anaemic (haemoglobin <110 g/L) at enrolment had a reduction in early infant mortality of 25% (RR 0.75, 0.62-0.90, p=0.0021) and 38% (RR 0.62, 0.49-0.78, p<0.0001), respectively. Combined fetal loss and neonatal deaths were reduced by 11% (RR 0.89, 0.81-1.00, p=0.045), with significant effects in undernourished (RR 0.85, 0.73-0.98, p=0.022) or anaemic (RR 0.71, 0.58-0.87, p=0.0010) women. A cohort of 11 101 infants weighed within 1 h of birth showed a 14% (RR 0.86, 0.73-1.01, p=0.060) decreased risk of low birthweight for those in the MMN group, with a 33% (RR 0.67, 0.51-0.89, p=0.0062) decrease for infants of women anaemic at enrolment. INTERPRETATION: Maternal MMN supplementation, as compared with IFA, can reduce early infant mortality, especially in undernourished and anaemic women. Maternal MMN supplementation might therefore be an important part of overall strengthening of prenatal-care programmes.

The eco-cultural context of the undernourished children in a study on the effects of early supplementary feeding in Indonesia.

OBJECTIVES: This paper describes the ecological and cultural backdrop of the subjects enrolled in an experimental study to test the validity of a conceptual model about the intellectual delay of undernourished children. DESIGN: The experiment was a 12-month clinical, randomized trial on the effects of early supplementary feeding on two cohorts of children classified as nutritionally-at-risk. Three different supplements (condensed milk + micronutrients; skimmed milk + micronutrients; skimmed milk) were given to the children during 6 or 12 months of the study. SETTING: The plantations are 1500-1800 m above sea level in Pangalengan, 50 km south of Bandung, West Java. Temperature fluctuates from 10 to 17 degrees C. A high yearly precipitation is approximately 3000 mm. Communities are laid out at 5-15 km from one another. Living conditions are modest. SUBJECTS: The 156 subjects were recruited from 24 day-care-centers (DCC) that serviced families of 24 communities in six tea plantations. The 12- and 18-month-old cohorts included 73 and 83 children, respectively; each cohort included three subgroups that received distinct supplements. OBSERVATIONS: The interactions of the caretakers with the children in the DCCs were consistent with the socialization for survival mode. A primary concern was the physical growth, health, cleanliness, sanitation and safety of the children. Stimulating children, providing toys and initiating play or other activities that would emphasize educational development had a low priority.

Community-level determinants of child growth in an Indonesian tea plantation.

OBJECTIVES: The paper presents the results of an ecological-economic approach to identifying community-level factors that influence the physical growth of young children. DESIGN: A cross-sectional design was used to obtain both the anthropometry and the ecological-economic data. SETTING: The sites were 24 communities located in a tea plantation near Bandung, West Java, Indonesia. SUBJECTS: 415 children between the ages of 6 and 18 months. METHODS: Epidemiological and ethnographic methods were used to measure community infrastructure and services related to child growth. Anthropometry was used to measure child growth. Econometric methods, including probit and ordinary least squares regression, were used to analyze the effect of community-level factors on child growth. RESULTS: Community vaccination programs, child care services, environmental sanitation and latrines were associated with better child growth. We concluded that community-level goods and services substantially contributed to health in early childhood.

Effects of an energy and micronutrient supplement on motor development and motor activity in undernourished children in Indonesia.

OBJECTIVES: This paper reports the effects of an energy and micronutrient supplement on the motor development, motor milestones and motor activity of nutritionally at risk infants and toddlers in Pangalengan, Indonesia. DESIGN: Two cohorts of children were randomly assigned to three treatments E = 1171 kJ + 12 mg iron; M = 209 kJ + 12 mg iron; S = 104 kJ. Supplementation was given for 12 months. SETTING: The sites were six tea plantations in Pangalengan, West Java. SUBJECTS: A 12-month-old (n = 53) and an 18-month-old (n = 83) cohort were recruited from day-care-centers. Twenty children that received S belonged to the 12- and 18-month-old cohorts. Inclusion criteria were: no chronic disease; length-for-age < or = -1 standard deviation (s.d.) and weight-for-length between -1 and -2 s.d. of the median of the reference of the World Health Organization. METHODS: Evaluations of intake were made at baseline and every 2 months thereafter. Motor development was assessed with the Bayley Scale and with a custom-made scale to assess gross motor development leading to bipedal locomotion. Motor activity was assessed through 4 h continuous observations of the child's interaction with the social and physical environment. RESULTS: In the 12-month-old cohort, as compared to the M and S groups the children that received the E supplement walked at an earlier age, had higher scores in the Bayley Scale and were motorically more active. Similar intergroup differences were observed in the 18-month-old cohort in the total motor activity score.

Effects of an energy and micronutrient supplement on skeletal maturation in undernourished children in Indonesia.

OBJECTIVES: This paper reports the effects of an energy and micronutrient supplement on skeletal maturation of nutritionally at risk infants and toddlers in Pangalengan, Indonesia. DESIGN: Two cohorts of children were randomly assigned to three treatments: E = 1171 kJoule + 12 mg iron; M = 12 mg iron + 209 kJ; S = 104 kJ. Supplementation was given for 12 months. SETTING: The sites were six tea plantations in Pangalengan, West Java. SUBJECTS: A 12-month-old (n = 53) and an 18-month-old (n = 83) cohort were recruited from day-care-centers. Twenty children that received S belonged to the 12- and 18-month-old cohorts. Inclusion criteria were: no chronic disease; length-for-age < or = -1 standard deviation (s.d.) and weight-for-length between -1 and -2 s.d. of the median of the reference of the World Health Organization. METHODS: Skeletal maturation was measured by X-ray of the left hand and wrist. The number of ossified centers and two different measures of skeletal age (Skel-1 and Skel-2) were the outcome variables measured. RESULTS: In the 12-month-old cohort, there were intergroup differences 6 and 12 months after baseline. First, the children in the E group were about 2 months more advanced in ossified centers than the children in the S group (P < 0.10). At 12 months, the children in the E group were about 3 months more advanced in skeletal age than the children in the M group. M group children were about 2.5 months behind the children in the S group.

Effects of an energy and micronutrient supplement on play behavior in undernourished children in Indonesia.

OBJECTIVES: This paper reports the effects of an energy and micronutrient supplementation on quantitative and qualitative aspects of play among poorly nourished children. At issue is whether the supplement led to a progression in complexity of play. DESIGN: Two cohorts of children were randomly assigned to three treatments: E = 1171 kJ + 12 mg iron; M = 12 mg iron + 209 kJ; S = 104 kJ. Supplementation was given for 6 months. Evaluations of play behavior were repeated four times. SETTING: The sites were six tea plantations in Pangalengan, West Java. SUBJECTS: The present study utilized a subsample of 55 children recruited for the larger Pangalengan project 6 months into the study. Thirty-eight children were recruited late enough to allow for longitudinal observations. The remaining cases were used for cross sectional observations only. Inclusion criteria were: no chronic disease; length-for-age < or = -1 standard deviation (s.d.) and weight-for-length between -1 and -2 s.d. of the median of the reference of the World Health Organization. METHODS: The children were videotaped during play. These tapes were coded for eight mutually exclusive categories of activities. Four activities coded represented manipulative, relational, functional and symbolic play. RESULTS: Treatment did not affect qualitative play. Girls that received E increased functional play but boys showed the opposite effect. Children in the S group were breastfed more during play as compared to the E group. Children in the E group waited less to begin play.

Effects of an energy and micronutrient supplement on iron deficiency anemia, physical activity and motor and mental development in undernourished children in Indonesia.

OBJECTIVES: This paper reports the effects of an energy and micronutrient supplementation on mental and motor development, activity and behavior under natural conditions of children classified as iron deficient anemic and iron replete. DESIGN: Children were randomly assigned to two different nutritional supplements: (1) 12 mg iron + either 1171 or 209 kJ; (2) 104 kJ + 0 iron. Treatment lasted for 6 months. SETTING: The sites were six tea plantations in Pangalengan, West Java. SUBJECTS: Eighteen anemic subjects (hemoglobin < 110 g/L; transferrin saturation (TS) < 16%) and 18 matched (sex and age) controls (hemoglobin > 110 g/L; TS > 16%) were selected from a pool of children with the following characteristics: no chronic disease; length-for-age < or = -1 standard deviation (s.d.) and weight-for-length between -1 and -2 s.d. of the median of the reference of the World Health Organization. METHODS: Hemoglobin, ferritin, transferrin saturation and erythrocyte protoporphyrin were evaluated before and 6 months after treatment. The following psychological measurements were obtained at baseline and 2, 4 and 6 months later. Mental and motor development was evaluated with the Bayley Scale. Motor activity was measured by 4 h continuous observations at home and at day care centers. The interactions between the child and its social and physical environment were also evaluated during 4 h of observations. RESULTS: Anemic children showed faster motor development and greater physical activity than the control children did. None of the other tests showed inter-group differences.

The effects of high energy and micronutrient supplementation on iron status in nutritionally at risk infants.

The study assessed the effects of supplementary feeding over 180 consecutive days on iron status of infants and toddlers at six tea plantation in West Java, Indonesia. The design used was a clinical trial: two eohorts (i.e., 12 and 18 months old children) and three treatment groups (i.e., energy + micronutrient, micronutrient alone, and placebo) per cohort. Every day except Sunday, the infants attended day-care centers. Twenty four centers and 136 infants were selected. The infants were screened for weight and length and those meeting the criteria (i.e., < -1 SD of length-for-age, and between -1 and -2 SD of weight-for-length of the NCHS reference) were included. The experimental unit was the day-care centers (DCC), where each DCC was randomly assigned to one of the three treatment. As expected, groups of energy + micronutrient and micronutrient alone of the 12 months cohort experienced a significant upward shift in hemoglobin, ferritin and TS and a downward change in FEP, while the values for the group of placebo remain about the same as at base line. In the first 6 month of treatments, the ANOVA for each iron indicator yielded significant main effects of treatment (P < 0.01) and for Hb with (P = 0.059) on 12 months cohort. On the other hand, the main effects of treatment on hemoglobin, TS, ferritin and FEP were not significant for the 18 months cohort. In the second 6 months of treatments, the only significant of the treatment effect (P < 0.01) was in serum ferritin on 18-month cohort. Under these circumstances, energy has a positive role in improving iron stores. It is likely that the equilibrium of hemoglobin and each iron indicators were reached in 6 months of treatment except ferritin still continued to increase up to 12 month. The effects of treatment on the improvement of iron status was stronger in 12 months than in 18 months.

Vitamin A-fortified monosodium glutamate and vitamin A status: a controlled field trial.

A controlled trial of fortification of crystalline monosodium glutamate (MSG) with 810 micrograms RE vitamin A/g was undertaken in an area of endemic vitamin A deficiency in Indonesia. Powdered MSG was used to mask the yellow color of the vitamin A. Fortified MSG was marketed through ordinary channels in five villages in the program area and five nearby villages served as the control area. The product retained 84% of its potency after 4 mo and 57% after 11 mo in the marketplace. Base-line serum and breast-milk vitamin A levels were slightly higher in the control areas. Follow-up serum levels increased dramatically in program villages, 0.67 +/- 0.33 at prefortification base line to 0.92 +/- 0.33 mumol/L (p less than 0.001) at 11 mo after introduction of the fortified product. Breast-milk levels also rose, from 0.60 +/- 0.29 at base line to 0.67 +/- 0.30 mumol/L at 11 mo (p less than 0.05). Serum and breast-milk levels in control villages did not change.