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Ten2Twenty-Ghana

The Interplay between Nutritional, Social and Economic Trajectories during Adolescence among Girls in Ghana

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON26929
Enrollment
620
Registered
2019-02-01
Start date
2019-02-11
Completion date
Unknown
Last updated
2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anaemic girls

Interventions

Participants in the treatment arm of the RCT will receive an multiple-micronutrient fortified biscuits (MMB) enriched with 11 vitamins (vitamins B1, B2, B6, B12, A, D, K1, E, niacin, folate and as

Sponsors

Wageningen University and Research and University for Development Studies
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. Must be an adolescent girl in either age cohort (Pre-menarche: 10-13 years or post-menarche:14-17 years). 2. Apparently healthy without any visible any visible sign(s) of poor health, non-pregnant and non-lactating 3. Must have Hb = 80g/L using a HemoCue in the field (will be referred to hospital if Hb <80g/L) 4. Not taking medication (medical drug use) or nutrient supplements (e.g. iron) at time of enrolment 5. Not currently participating in another intervention study with food, supplement or drug 6. Willing to consume biscuits from Monday-Friday (5 times per week) as a snack at school for 26 weeks 7. Must have no history of medical or surgical events that may significantly affect the study outcome 8. No sign of chronic infection or metabolic disorder 9. No Mental status that is incompatible with the proper conduct of the study 10. Not afraid to donate approximately 12ml of blood (~2.5 teaspoons) on 2 different occasions during the study 11. Willing to participate and informed consent of parent/guardian obtained

Exclusion criteria

Exclusion criteria: 1. Having a history of medical or surgical events that may significantly affect the study outcome. 2. Severely anaemic (Hb < 80g/L); excluded from the study and referred to the hospital. 3. Medical drug use. 4. Any sign of chronic infection or metabolic disorder. 5. Currently participating in another intervention study with food, a supplement or drug 6. Clinical signs of vitamin A deficiency (cornea ulceration, night blindness) and clinical signs of iodine deficiency (visible goitre). 7. Severely underweight (BAZ < -3 SD). 8. Have any known food allergy to biscuits. 9. Not willing or afraid to give up blood donation during the study. 10. Refusal of parents.

Design outcomes

Primary

MeasureTime frame
Changes in micronutrient status ?Hb ?Serum ferritin (SF) ?Serum transferrin receptor (sTfR), ?Retinol-binding protein (RBP) ?Serum zinc ?Serum folate ?Vitamin B12

Secondary

MeasureTime frame
? Anthropometric indicators (e.g. attained height, height-for-age z-score, body-mass-index-for-age z-score) and body composition (bio-electric impedance) ? Cognitive development/skills ? Academic performance ? Perceptions and aspirations (qualitative)

Contacts

Public ContactFusta Azupogo

Wageningen University and Research

fusta.azupogo@wur.nl+233246280485

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)