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Many preemies need at least 800 IU of vitamin D – RCT May 2013

Preterm infants may need 800 IU of vitamin D3 per day


The American Academy of Pediatrics PAS MEETING UPDATE:

Carla Kemp, Senior Editor

Preterm infants may need to be given 800 international units (IU) of vitamin D a day to ensure they develop strong bones, according to a study to be presented Sunday, May 5, at the Pediatric Academic Societies (PAS) annual meeting in Washington, D.C.

Preemies are known to be at risk for vitamin D insufficiency. If levels of vitamin D are too low, infants and children can get rickets, which leads to softening and weakening of the bones.

Recommendations from medical organizations on how much vitamin D should be given to preemies range from 400 IU to 1000 IU per day.
This lack of consensus prompted researchers from All India Institute of Medical Sciences, New Delhi, to conduct the largest study to date on vitamin D supplementation in preterm infants.

Subjects included 96 infants born between 28 and 34 weeks’ gestation who were receiving milk feeding. Blood samples were taken from the infants to determine their serum vitamin D levels.
The infants then were randomly assigned to receive either 800 IU or 400 IU of oral vitamin D3.
Neither the parents nor the primary investigator was aware of which dose the infants were receiving.

Researchers compared whether the prevalence of vitamin D insufficiency (VDI) at 40 weeks and at 3 months corrected age differed between the groups.
They also looked at whether infants with higher vitamin D levels also had stronger bones at 3 months corrected age and whether supplementation led to vitamin D levels that were too high.

Results showed that VDI was common in both groups before they received supplements (79% of the 800 IU group and 83% of the 400 IU group).

After supplementation, the prevalence of VDI at 40 weeks was 43% lower in the 800 IU group than the 400 IU group (38% vs. 67%). In addition,
VDI was significantly lower in the 800 IU group when the infants were 3 months old (12% vs. 35%).

Four infants needed to be supplemented with 800 IU daily to reduce one case of vitamin D insufficiency, said lead author Chandra Kumar Natarajan, DM.

“The study results show conclusively that in preterm infants with high rates of vitamin D insufficiency at baseline, supplementation with 800 IU of vitamin D3 per day compared to 400 IU per day reduces vitamin D insufficiency at term equivalent age and at 3 months,” Dr. Natarajan said. “There also is a trend toward a decrease in the prevalence of vitamin D insufficiency even in the 400 IU group at 3 months. Therefore, 400 IU per day may be sufficient after 3 months.”

Despite significant improvement in serum vitamin D levels in the 800 IU group, higher levels did not result in better bone mineralization at 3 months of age as measured by dual energy X-ray absorptiometry. In addition, weight, length and head circumference did not differ significantly between the groups.

Dr. Natarajan also noted that one infant in the 800 IU group had vitamin D levels that were higher than recommended levels at 3 months of age despite the levels at term age being normal. Excess vitamin D for at least one month can cause decreased muscle tone, decreased appetite, irritability and constipation, among other problems. The infant did not experience any major effects.

“The incidence of vitamin D excess in the 800 IU group may indicate the need for monitoring vitamin D levels in infants on vitamin D supplementation, but we need larger studies to answer this,” he said. “Similarly, larger studies with longer duration of follow-up may be needed to find out any meaningful difference in clinical outcomes such as bone mineralization.”

To view the abstract, “Daily Vitamin D Supplementation with 800 IU vs. 400 IU in Preterm Infants: A Randomized Trial,”
go to http://www.abstracts2view.com/pas/view.php?nu=PAS13L1_2183.8.  which is at the bottom of this page


Comments by VitaminDWiki

This study did not use any of the vitamin D cofactors which have been shown to balance the blood chemistry

 

Vitamin D Dose Deficiency
400 IU Measured 67%
800 IU Measured 38%
1200 IU Wonder? 20%

Note: More vitamin D is fine/needed for infants born at 9 months in other studies

See also VitaminDWiki



2183.8 Daily Vitamin D Supplementation with 800 IU vs. 400 IU in Preterm Infants: A Randomized Trial

Chandra Kumar N, M. Jeeva Sankar, Ramesh Agarwal, O. Tejo Pratap, Vandana Jain, Nandita Gupta, Arun K. Gupta, Ashok K. Deorari, Vinod K. Paul, V. Sreenivas. Division of Neonatology, Pediatrics, All India Institute of Medical Sciences, New Delhi, India; Endocrinology& Metabolism, All India Institute of Medical Sciences, New Delhi, India; Radiodiagnosis, All India Institute of Medical Sciences, New Delhi, India; Biostatistics, All India Institute of Medical Sciences, New Delhi, India.

BACKGROUND: Consensus is lacking in regard to the dose of vitamin D supplementation required for preterm infants given the paucity of evidence. AAP, ESPGHAN and WHO have recommended different dosages of vitamin D ranging from 400 IU to 1000 IU per day.
OBJECTIVE: Primary To compare the prevalence of vitamin D insufficiency (VDI; serum 25 hydroxy vitamin D <20 ng/mL) at 40 weeks postmenstrual age (PMA) in preterm infants of 28 to 34 weeks' gestation randomized to receive 800 IU or 400 IU of oral vitamin D3 per day. Secondary To compare the (1) prevalence of VDI at 3m corrected age (CA), (2) incidence of vitamin D toxicity, as assessed by urine calcium creatinine ratio (UCa/Cr) for hypercalciuria and renal ultrasound for nephrocalcinosis during therapy and (3) bone mineral content (BMC) and bone mineral density (BMD) by dual energy x-ray absorptiometry (DEXA) at 3m CA.
DESIGN/METHODS: In this randomized double blind trial, we allocated infants to 800 IU/ day or 400 IU/day of oral vitamin D3 (n=48 in both groups) from the time of full enteral feeds until 3m CA. UCa/Cr in a spot sample and renal ultrasound were performed both at 40 weeks PMA and 3m CA while DEXA was done at 3m CA.
RESULTS: The prevalence of VDI in '800 IU group' was significantly lower than '400 IU group' at 40 weeks and at 3m CA.
 

Prevalence of vitamin D insufficiency
Vitamin D insufficiency
(Serum 25(OH)D <20 ng/mL)
 
800 IU
 
 
(n=42)
 
   
400 IU
 
 
(n=45)
 
  RR (95% CI) NNT (95% CI) p
40±2 weeks n (%) 16 (38) 30 (67) 0.57 (0.37 to 0.88) 4 (2 to 12) 0.008
3 months corrected age n (%) 5 (12) 14 (35) 0.36 (0.14 to 0.90) 4 (3 to 20) 0.03



One infant (2.4%, 95% CI: 0.06 to 12.5) in the '800 IU group' had vitamin D excess (100 to 150 ng/mL) at 3m CA. Spot UCa/Cr ratio >0.8 mg/mg did not differ significantly at 40 weeks (64% vs. 45%) and at 3m CA (15.4% vs. 20.8%). Nephrocalcinosis was not found in any of the cases. BMC (mean (SD): 79.6 (16.8) vs. 84.7 (20.7) g; p=0.27) and BMD (0.152 (0.019) vs. 0.158 (0.021) g/cm2;p=0.26) were not different between the groups.
CONCLUSIONS: Daily supplementation with 800 IU of vitamin D reduces the prevalence of vitamin D insufficiency at 40 weeks and at 3 m CA in preterm infants without having any improvement in bone mineralization. However there is a possibility that this dose may result in vitamin D excess in minority of supplemented infants.
First Author is a Fellow in Training

E-PAS2013:2183.8

Session: Platform Session: Neonatal Fetal Nutrition & Metabolism I (8:00 AM - 10:00 AM)
Date/Time: Sunday, May 5, 2013 - 9:45 AM
Room: 204C - Walter E. Washington Convention Center
Course Code: 2183

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