Effects of Vitamin D supplementation on resolution of fever and cough in children with pulmonary tuberculosis: A randomized double-blind controlled trial in Indonesia.

BACKGROUND: Various studies in adults have shown a strong association between vitamin D and tuberculosis (TB), both in terms of vitamin D status and the benefits of vitamin D in managing TB. Studies on vitamin D and its relationship with childhood TB still lack in Indonesia as a country with the second-highest TB incidence globally. This study evaluated the effect of vitamin D supplementation on resolution of cough and fever in Indonesian children with pulmonary TB. METHODS: We conducted a randomized controlled trial of vitamin D supplementation in children with pulmonary TB and vitamin D insufficiency. Patients were randomly allocated with 1:1 ratio to receive either 1000 IU vitamin D or placebo daily after starting standard TB treatment. The primary outcome in this study was the resolution of fever and cough symptoms reviewed weekly after starting the treatment until the symptoms are resolved. The secondary outcome in this study was 25-hydroxyvitamin D serum level and nutritional status which was reviewed at the end of the trial. Intention to treat analyses were applied. Differences in clinical outcomes between two groups were calculated using Mann-Whitney U test or χ2 test, where appropriate. FINDINGS: A total of 84 patients met the inclusion criteria, aged 6 to 18 years old, newly diagnosed with pulmonary TB and vitamin D insufficiency. Eighty patients (95,2%) completed the six months follow-up. Faster resolution of fever, cough, improved malnutrition status, and higher vitamin D level were found in the intervention group compared to the placebo group (all P < 0.001). CONCLUSIONS: Vitamin D is beneficial in improving fever and cough resolution, and improving nutritional status in children with pulmonary TB and vitamin D insufficiency. Determination of adequate supplementation levels of more than 1000 IU requires further research to achieve normal vitamin D levels during the duration of treatment for pulmonary TB in children. TRIAL REGISTRATION: ClinicalTrials.gov (NCT05073965).

Association of complex lipids containing gangliosides with cognitive development of 6-month-old infants.

BACKGROUND: Human breastmilk contains gangliosides which may play an important role in infant neurodevelopment. AIM: A pilot study was conducted to assess the impact of infant formula supplemented with gangliosides from complex milk lipid on cognitive functions of normal healthy infants. STUDY DESIGN: The study was a double-blind, randomized, controlled, parallel group clinical trial in which infants received the treatment or control product from 2 to 8 weeks of age until 24 weeks of age. The control group (n=30) received standard infant formula and the treatment group (n=29) received the same formula supplemented with complex milk lipid to increase the ganglioside content to approximately 11 to 12 µg/ml. A reference group (n=32) consisted of normal healthy exclusively breast-fed infants. OUTCOME MEASURES: Cognitive development using the Griffith Scales and serum gangliosides was measured before (2-8 weeks of age) and after intervention (24 weeks of age). RESULTS: Ganglioside supplementation using complex milk lipids significantly increased ganglioside serum levels (control group vs treatment group, P=0.002) and resulted in increased scores for Hand and Eye coordination IQ (P<0.006), Performance IQ (P<0.001) and General IQ (P=0.041). Cognitive development scores and serum ganglioside levels for the treatment group did not differ from the reference group. CONCLUSIONS: Supplementation of infant formula with complex milk lipid to enhance ganglioside content appears to have beneficial effects on cognitive development in healthy infants aged 0-6 months, which may be related to increased serum ganglioside levels.