Haematological Disorders Nutritional, Metabolic, Endocrine Menstruation, anaemia
Conditions
Interventions
Multiple micronutrient supplements and ibuprofen
Multiple micronutrient supplements and ibuprofen placebo
Ibuprofen
Sponsors
Training and Research Unit of Excellence
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: 1. Aged 15-20 years 2. Successful assessment of menstrual blood loss during the run-in period 3. Must be registered in (boarding) schools participating in the study at least until the scheduled end of the intervention period 4. Nulliparous (self-reported) 5. Post-menarcheal (by self-report) 6. Written informed consent obtained from girls = 18 years 7. Written informed assent obtained from girls <18 years and written informed consent from parent or guardian.
Exclusion criteria
Exclusion criteria: 1. Married (because married girls are more likely to become pregnant) 2. Pregnant (as determined by human chorionic gonadotropin (hCG) urine test) 3. Severe anemic (hemoglobin concentration <70 g/L) 4. Amenorrheal for the last 3 months or more (by self-report) 5. Using hormonal contraceptives (oral, injection, implants) 6. Body weight = 30kg 7. Chronically ill or suffering from any severe systemic disease (e.g., sickle cell disease, self-reported AIDS, tuberculosis, severe renal or heart disease) 8. Consuming or having consumed supplements containing iron or folic acid in the last month. 9. Self-reported history of thrombosis or renal impairment 10. Allergic to ibuprofen or NSAIDs 11. Unwilling to forego NSAIDs during menstruation other than ibuprofen (or its placebo) that is provided as part of the study 12. Febrile (axillary temperature =37.5 °C) at randomization visit. 13. Recent blood in stool or vomit following use of pain/anti-inflammatory medications 14. History of ulcers or bleeding in the stomach or duodenum 15. Any active bleeding other than menstruation 16. Unwilling to take part in the sub-study (will only be excluded for the sub-study)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Menstrual blood volume loss (mL/cycle);Menstrual duration (days/cycle);Menstrual blood volume loss (mL/cycle);Menstrual duration (days/cycle) | — |
Secondary
| Measure | Time frame |
|---|---|
| Menstrual iron loss (mg/day) calculated as the product of total blood loss for each menstruation (mL), haemoglobin concentration (g/mL) and a constant indicating iron content of haemoglobin, divided by menstrual cycle length (in days).;Iron stores (as indicated by serum concentrations of ferritin);Iron status (as indicated by blood hemoglobin concentration and concentrations of soluble transferrin receptor and serum ferritin) with adjustment for concurrently measured inflammation markers.;Menstrual cycle length, measured as the time period (days) between the first days of two successive periods.;Menstrual pad count per menstruation;Menstrual pain, measured using a visual analogue scale;Depressive symptoms measured using the Depression, Anxiety and Stress Scale - 21 Items (DASS-21) and Beck’s Depression Inventory (BDI-IA);Quality of Life (social participation, physical activities, work in or outside the home) will be measured using the Adolescent Menstrual Bleeding Questionnaire (a-MBQ), the Menstrual Practices Questionnaire (MPQ) and the Menstrual Practices Needs Scale (MPNS-36) questionnaire ;School absenteism will be assessed as missed school hours due to self-reported reasons for absenteeism related to menstruation, including absence due to dysmenorrhea, period cramps before the onset of a period.;Incidence of episodes of malaria and other morbidities during follow-up. Episodes of malaria will be defined as confirmed fever (axillary temperature >37.5°C) in the presence of Plasmodium infection as indicated by rapid dipstick test.;Prevalence of P. falciparum infection measured by the presence of serum concentration of histidine-rich protein-2 (HRP-2) ;Prevalence of bacterial vaginosis, defined by patterns of vaginal microbiota taxa in (self)-administered vagina swabs that are characteristic for this condition.;Prevalence of gut pathogens and gut inflammation measured by presence and density in stool samples of DNA sequences specific for these pathogens) and a stool | — |
Countries
Malawi
Contacts
Public ContactKesso Gabrielle van Zutphen Kuffer
Wageningen University and Research
Outcome results
None listed