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Completed

NCT Number: NCT04270643

Trial of High-Dose Vitamin D in the Treatment of Complicated Severe Acute Malnutrition

This double-blind randomized placebo-controlled controlled trial will test the hypothesis that administration of high-dose oral vitamin D supplementation to children in Lahore, Pakistan, who are recovering from complicated severe acute malnutrition will safely accelerate weight gain (primary outcome) and enhance neurodevelopment, muscle mass accumulation, resolution of systemic inflammation and antimicrobial immune function (secondary outcomes).

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Key information

Age range

6 month–5 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Sir Ganga Ram Hospital, Lahore, Pakistan

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Consent of parent / guardian
  • Age 6-59 months at enrolment
  • Diagnosis of complicated SAM at the point of hospital admission as defined by the World Health Organisation.
  • Medical team managing the child has made the decision to discharge the child from inpatient care

Exclusion criteria

  • Ingestion of a dose of vitamin D>200,000 IU (5 mg) in the last 3 months
  • Known diagnosis of primary hyperparathyroidism or sarcoidosis (i.e. conditions pre-disposing to vitamin D hypersensitivity)
  • Known neurodevelopmental disorder (e.g. cerebral palsy)
  • HIV infection
  • Taking anti-tuberculosis treatment
  • Inability to assess child's developmental status at baseline using the Malawi Development Assessment Tool
  • Signs of rickets
  • Corrected serum calcium concentration >2.65 mmol/L on blood sample taken during the current hospital admission

Treatment and study plan

Vitamin D3

Dietary Supplement

ATC code A11CC05 (cholecalciferol)

Placebo

Dietary Supplement

Ethyl oleate

Primary outcomes

  1. Mean weight-for-height/length z-score

    Time frame: 2 months

Secondary outcomes

  1. Mean weight-for-height/length z-score

    Time frame: 6 months

  2. Mean weight-for-age z-score

    Time frame: 2 and 6 months

  3. Mean height/length-for-age z-score

    Time frame: 2 and 6 months

  4. Mean head circumference-for-age z-score

    Time frame: 2 and 6 months

  5. Mean mid-upper arm circumference

    Time frame: 2 and 6 months

  6. Mean change in overall and domain-specific (gross motor, fine motor, language and social) neurodevelopmental scores, Malawi Developmental Assessment Tool

    Time frame: 2 and 6 months

  7. Mean fat mass index

    Time frame: 2 and 6 months

  8. Mean fat-free mass index

    Time frame: 2 and 6 months

  9. Proportion of participants experiencing relapse of severe acute malnutrition

    Time frame: 6 months

  10. Proportion of participants readmitted to hospital due to any cause

    Time frame: 6 months

  11. Antimicrobial immune function (concentrations of inflammatory mediators in supernatants of whole blood stimulated with lipo-polysaccharide, zymosan and heat-killed Salmonella typhi)

    Time frame: 2 and 6 months

  12. Serum concentrations of albumin, C-reactive protein, 25-hydroxyvitamin D, total alkaline phosphatase, parathyroid hormone, ferritin and hepcidin

    Time frame: 2 and 6 months

  13. Mean haemoglobin concentration, full blood count

    Time frame: 2 and 6 months

  14. Mean corpuscular volume, full blood count

    Time frame: 2 and 6 months

  15. Mean corpuscular haemoglobin concentration, full blood count

    Time frame: 2 and 6 months

  16. Mean neutrophil count, full blood count

    Time frame: 2 and 6 months

  17. Mean lymphocyte count, full blood count

    Time frame: 2 and 6 months

  18. Mean monocyte count, full blood count

    Time frame: 2 and 6 months

  19. Faecal concentrations of inflammatory markers (myeloperoxidase, neopterin and alpha-1 antitrypsin)

    Time frame: 2 and 6 months

  20. Faecal microbiome composition

    Time frame: 2 and 6 months

  21. Proportion of participants dying

    Time frame: 6 months

  22. Incidence of serious adverse events

    Time frame: 6 months

  23. Incidence of adverse reactions

    Time frame: 6 months

Sponsors and collaborators

Lead sponsor

Queen Mary University of London

Other

Collaborators

  • University College, London
  • University of the Punjab

Registry information

Acronym: ViDiSAM

Important dates

Study start
2021
Primary completion
2024
Study completion
2024
First posted
Feb 17, 2020
Registry last updated
Jul 8, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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