Table 1

Timing of interventions and measurements

PregnancyBirth-
2 weeks
Month of life
1234567891011121518
Recruitment, consentXX
EnrolmentX
Interventions
A. Nicotinamide intervention
 Nicotinamide (or placebo) to mother: daily 0–6 monthsXXXXXX
 Nicotinamide (or placebo) to child: daily 6–12 monthsXXXXXXXX
B. Antimicrobial intervention
 Azithromycin single dose to childXXXX
 Nitazoxanide 3 day course to childXX
Measurements
A. Mother
 Weight: Month 11X
 Height: Month 11X
 BloodX
 StoolX
 Saliva (FUT2 secretor status)XX
B. Child
 1. Anthropometry
  WeightXXXXXXXXXXXXXXX
  Length, head circumference, mid-upper arm circ.XXXXXXX
 2. Questionnaire
  Education, environment, socioeconomicX
  Illness, treatment, breast feeding, food securityXXXXXXXXXXXXXX
 3. Breast milk: Months 1 and 5
  Tryptophan, niacin, nicotinamide, vitamersXX
  VitaminsXX
  ProteinXX
 4. Blood
  Safety assessment (CMP, CBC in subset)XX
  HaemoglobinXX
  IGF-1XX
  CRPXX
  Collagen XXX
  Tryptophan metabolitesXX
  MetabolomicsXX
 5. Stool
  MicrobiomeX*XX
  Taqman Array CardsX*X*X
  MyeloperoxidaseXXX
 6. Urine
  MetabolomicsXXX
 7. Saliva
  FUT2 secretor statusX
 8. Breath
  H2, methane (small intestinal bacterial overgrowth)XXX
 9. Developmental testing
  Observation of Maternal Child InteractionX
  Malawi Developmental Assessment ToolX
  Bayley Scales of DevelopmentX
  • *Evaluation also performed two weeks after anti-microbial dose.

  • CBC, complete blood count; CMP,comprehensive metabolic panel; CRP, C reactive protein; FUT2, fucosyltransferase 2; IGF-1, insulin-like growth factor-1; ITT, intention-to-treat.