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Vitamin D for Growth and Rickets in Stunted Children: a Randomized Trial

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Vitamin D for Growth and Rickets in Stunted Children: a Randomized Trial Vitamin D for Growth and Rickets in Stunted Children: A Randomized Trial Francesca L. Crowe, BSc, PhD,a,* M. Zulf Mughal, MBChB, FRCP, FRCPCH,b,* Zabihullah Maroof, MD, MPH, PhD,c,d Jacqueline Berry, BSc, PhD,e Musa Kaleem, MBBS, MD,f Sravya Abburu, MBSS,g Gijs Walraven, MD, MPH, PhD,h Mohammad I. Masher, MD,i Daniel Chandramohan, MBBS, MSc, PhD,c Semira Manaseki-Holland, BMedSci, MBBS, MSc, MRCP, MFPHM, PhDc,d BACKGROUND AND OBJECTIVES: Vitamin D is essential for healthy development of bones, but little is abstract known about the effects of supplementation in young stunted children. Our objective was to assess the effect of vitamin D supplementation on risk of rickets and linear growth among Afghan children. METHODS: In this double-blind, placebo-controlled trial, 3046 children ages 1 to 11 months from inner-city Kabul were randomly assigned to receive oral vitamin D3 (100 000 IU) or placebo every 3 months for 18 months. Rickets Severity Score was calculated by using wrist and knee radiographs for 631 randomly selected infants at 18 months, and rickets was defined as a score .1.5. Weight and length were measured at baseline and 18 months by using standard techniques, and z scores were calculated. RESULTS: Mean (95% confidence interval [CI]) serum 25-hydroxyvitamin D (seasonally corrected) and dietary calcium intake were insufficient at 37 (35–39) nmol/L and 372 (327–418) mg/day, respectively. Prevalence of rickets was 5.5% (placebo) and 5.3% (vitamin D): odds ratio 0.96 (95% CI: 0.48 to 1.92); P = .9. The mean difference in height-for-age z score was 0.05 (95% CI: 20.05 to 0.15), P = .3, although the effect of vitamin D was greater for those consuming .300 mg/day of dietary calcium (0.14 [95% CI: 0 to 0.29]; P = .05). There were no between-group differences in weight-for-age or weight-for-height z scores. CONCLUSIONS: Except in those with higher calcium intake, vitamin D supplementation had no effect on rickets or growth. aInstitute of Applied Health Research, College of Medical and Dental Sciences, University of Birmingham, WHAT’S KNOWN ON THIS SUBJECT: Few trials have Birmingham, United Kingdom; bDepartment of Paediatric Endocrinology, Royal Manchester Children’s Hospital, been used to examine whether vitamin D Manchester, United Kingdom; cDepartment of Disease Control, London School of Hygiene and Tropical Medicine, supplementation can prevent rickets or improve London, United Kingdom; dAga Khan Health Service, Kabul, Afghanistan; eEndocrinology and Diabetes Research f growth. Vitamin D supplementation potentially Group, Institute of Human Development, University of Manchester, Manchester, United Kingdom; Department of fi Radiology, Alder Hey Children’s Hospital, Liverpool, United Kingdom; gDepartment of Obstetrics and Gynaecology, prevents rickets in children de cient in vitamin D and New Cross Hospital, Wolverhampton, United Kingdom; hAga Khan Development Network, Geneva, Switzerland; and increases height in subpopulations of young teenagers iDepartment of Pediatrics, Kabul Medical University, Kabul, Afghanistan and premature infants. *Contributed equally as co-first authors WHAT THIS STUDY ADDS: In a highly stunted population insufficient (not deficient) in vitamin D and Dr Crowe designed the analysis plan, analyzed the data, and drafted the manuscript; Prof Mughal calcium using vitamin D supplementation every 3 made substantial contributions to the conceptualization and design of the study and drafted the fi manuscript; Dr Maroof was the trial manager, managed the implementation of the study, and months, there was no statistically signi cant reduction revised the manuscript critically for important intellectual content; Dr Berry led the analysis of in rickets or improved growth. In those with calcium blood 25-hydroxyvitamin D and parathyroid hormone, made a substantial contribution to the intake .300mg/day, height improved. interpretation of the data, and revised the manuscript critically for important intellectual content; Dr Kaleem led the analysis of the wrist and knee radiographs, made a substantial contribution to the interpretation of the data, and revised the manuscript critically for important intellectual To cite: Crowe FL, Mughal MZ, Maroof Z, et al. Vitamin D content; Dr Abburu led the analysis of the dietary data, made a substantial contribution to the for Growth and Rickets in Stunted Children: A interpretation of the data, and revised the manuscript critically for important intellectual content; Randomized Trial. Pediatrics. 2021;147(1):e20200815 (Continued) Downloaded from www.aappublications.org/news by guest on September 25, 2021 PEDIATRICS Volume 147, number 1, January 2021:e20200815 ARTICLE Afghanistan, a low-income country, and weekly home supplementation Approvals, Consent, and Registration has one of the highest rates of child regimens often have poor The study protocol was approved by mortality among children ,5 years of adherence12,13 and bolus doses 1 the ethics and review board of the age in the region. Although implemented during regular child Ministry of Public Health of improvements in nutrition and the health contacts (eg, vaccination) are Afghanistan (reference: 422328) and alleviation of poverty have led to important supplementation methods the ethics committee of the London a reduction in mortality in recent for programmatic purposes. School of Hygiene and Tropical years,2 undernutrition still poses Vitamin D deficiency and Medicine (application 5117). a big threat to the health of Afghan malnutrition are common problems Thumbprint or signature consent children, with one of the highest in Afghanistan,3,14 making it an ideal from the mother, father, or other head prevalence of childhood stunting study population in which to examine of the household was obtained after ranging from 40%3 to .80% in some the effects of vitamin D on bones and either parent read the consent form districts.4 Factors associated with growth, which may be relevant to or it was explained to him or her by stunting include sanitation, food other low- and middle-income the field-worker. This study was insecurity, and low dietary countries (LMICs). Here, we assess registered at www.clinicaltrials.gov diversity,2,4 and children in the effect of vitamin D (identifier NCT00548379). Afghanistan ,5 years have high rates supplementation on the risk of of anemia and deficiencies in vitamins rickets, as measured by the Thacher Participants A and D.3 radiologic score (hereafter known as The children enrolled in the study the Rickets Severity Score [RSS]), and Vitamin D is essential for children mainly were from socioeconomically growth parameters of children who achieving optimal linear growth and deprived inner-city districts in Kabul participated in a randomized development of bones.5 Nutritional and aged 1 to 11 months. A total of controlled trial in Afghanistan. rickets is a condition in which there is 3060 children were assessed for Chronically low dietary calcium impaired mineralization of the eligibility and 3046 children were intake, with or without vitamin D growth plate and osteoid in a growing randomly assigned to the vitamin D deficiency or insufficiency, also leads n n child. It can lead to deformities of the ( = 1524) or placebo group ( = to rickets in a growing child.6 lower limbs and pelvis and in severe 1522). Therefore, we have also examined the cases is associated with fragility role that dietary calcium intake may Randomization fractures.6,7 Deficiency in vitamin D have in the causation of rickets. or dietary calcium intake, or An independent statistician a combination of both these factors, individually randomized unique can cause nutritional rickets.6 METHODS identification numbers in blocks of 20 Vitamin D deficiency arises when to the vitamin D or placebo group by there is inadequate exposure of the Study Design use of a random number generator skin to sunlight or insufficient dietary A more detailed description of the with the SAS (SAS Institute, Inc, Cary, intake.8,9 Besides being a major cause trial methods, including the trial NC) routine. of rickets and osteomalacia, vitamin D profile, has been published deficiency might also lead to impaired elsewhere.15 Briefly, this trial was Intervention growth. Randomized control trials a community-based, double-blind, We prepared 2.5 mg of vitamin D3 of vitamin D supplementation randomized, placebo-controlled (cholecalciferol) dissolved in 1 mL of revealed improvements in growth parallel trial that was conducted olive oil (vitamin D) or 1 mL of olive in premature low birth weight between November 2007 and June oil alone (placebo) in sealed plastic neonates in India10 and in school- 2009 in 5 inner-city districts of Kabul, syringes. The vitamin D in olive oil aged children (11–13 years) in Afghanistan. The primary objective of and placebo syringes were identical Mongolia.11 The duration of vitamin D the trial was to evaluate the effect of in appearance, and all families and supplementation and follow-up in quarterly supplementation of study personnel, including the these 2 trials was only 6 months, and 100 000 IU (2.5 mg) of cholecalciferol clinicians, were blinded to the group it is not clear whether a longer period (vitamin D3) on the incidence and/or allocation of the child. Vitamin D or of vitamin D supplementation as severity of childhood pneumonia. A placebo was given by the field-worker bolus doses in young children priori secondary objectives of the to the child on a quarterly basis; undergoing rapid periods of growth study were to assess the effect of doses were given in November 2007, (6–24 months) leads to greater vitamin D3 supplementation on the February 2008, May 2008, August improvements in growth or prevents risk of rickets and linear growth 2008, and December 2008, and the cases of rickets. Additionally, daily among children. final (sixth) dose was given in March Downloaded from www.aappublications.org/news by guest on September 25, 2021 2 CROWE et al 2009.
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